Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301 et seq., United States of America

Federal Food, Drug, and Cosmetic Act As amended through December 31, 2004 (See note below)

Chapter I--Short Title Chapter II--Definitions Chapter III--Prohibited Acts and Penalties Chapter IV--Food Chapter V--Drugs and Devices:

Subchapter A--Drugs and Devices: Sections 501-510: Drugs and Devices Section 512: New Animal Drugs Sections 513-523: Medical Devices Subchapter B--Drugs for Rare Diseases and Conditions Subchapter C--Electronic Product Radiation Control Subchapter D--Dissemination of Treatment Information Subchapter E--General Provisions Relating to Drugs and Devices Subchapter F—New Animal Drugs for Minor Use and Minor Species

Chapter VI--Cosmetics Chapter VII--General Authority: Subchapter A--General Administrative Provisions Subchapter B--Colors Subchapter C--Fees Subchapter D--Information and Education Subchapter E--Environmental Impact Review Subchapter F--National Uniformity for Nonprescription Drugs and Preemption for Labeling or Packaging of Cosmetics Subchapter G--Safety Reports

Chapter VIII--Imports and Exports Chapter IX--Miscellaneous

Appendix: Section 107(c) of Drug Amendments of 1962 Public Law 88-136; Revolving Fund Section 108 of Animal Drug Amendments of 1968

Section 5 of Orphan Drug Act

Cross-reference of FD&C Act and U.S. Code section numbers

The FDA's online reference edition of the Federal Food, Drug and Cosmetic Act is based on the publication Compilation of Selected Acts Within the Jurisdiction of the Committee on Energy and Commerce; Food, Drug, and Related Law, As Amended Through December 31, 2004, prepared for the use of the Committee on Energy and Commerce, U.S. House of Representatives, March 2005. Some updates to the Act were incorporated in November 2007.

CHAPTER I— SHORT TITLE

Section 1 . [21 U.S.C. 301] This Act may be cited as the Federal Food, Drug, and Cosmetic

Act.

CHAPTER II—DEFINITIONS1

SEC. 201. [21 U.S.C. 321] For the purposes of this Act— 2

(a)(1) The term "State", except as used in the last sentence of section 702(a), means any

State or Territory of the United States , the District of Columbia , and the Commonwealth of

Puerto Rico .

(2) The term "Territory" means any Territory or possession of the United States , including the

District of Columbia , and excluding the Commonwealth of Puerto Rico and the Canal Zone.

(b) The term "interstate commerce" means (1) commerce between any State or Territory and

any place outside thereof, and (2) commerce within the District of Columbia or within any other

Territory not organized with a legislative body.

(c) The term "Department" means the Department of Health and Human Services.

(d) The term "Secretary" means the Secretary of Health and Human Services.

(e) The term "person" includes individual, partnership, corporation, and association.

(f) 1 The term "food" means (1) articles used for food or drink for man or other animals, (2)

chewing gum, and (3) articles used for components of any such article.

(g)(1) The term "drug" means (A) articles recognized in the official United States

Pharmacopeia, official Homeopathic Pharmacopeia of the United States, or official National

Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis,

cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles

(other than food) intended to affect the structure or any function of the body of man or other

animals; and (D) articles intended for use as a component of any articles specified in clause

(A), (B), or (C). A food or dietary supplement for which a claim, subject to sections 403(r)(1)(B)

and 403(r)(3) or sections 403(r)(1)(B) and 403(r)(5)(D), is made in accordance with the

requirements of section 403(r) is not a drug solely because the label or the labeling contains

such a claim. A food, dietary ingredient, or dietary supplement for which a truthful and not

misleading statement is made in accordance with section 403(r)(6) is not a drug under clause

(C) solely because the label or the labeling contains such a statement.

(2) The term "counterfeit drug" means a drug which, or the container or labeling of which,

without authorization, bears the trademark, trade name, or other identifying mark, imprint, or

device, or any likeness thereof, of a drug manufacturer, processor, packer, or distributor other

than the person or persons who in fact manufactured, processed, packed, or distributed such

drug and which thereby falsely purports or is represented to be the product of, or to have been

packed or distributed by, such other drug manufacturer, processor, packer, or distributor.

(h) The term "device" (except when used in paragraph (n) of this section and in sections 301(i),

403(f), 502(c), and 602(c)) means an instrument, apparatus, implement, machine, contrivance,

implant, in vitro reagent, or other similar or related article, including any component, part, or

accessory, which is—

(1) recognized in the official National Formulary, or the United States Pharmacopeia, or any

supplement to them,

(2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation,

treatment, or prevention of disease, in man or other animals, or

(3) intended to affect the structure or any function of the body of man or other animals, and

which does not achieve its primary intended purposes through chemical action within or on the

body of man or other animals and which is not dependent upon being metabolized for the

achievement of its primary intended purposes.

(i) The term "cosmetic" means (1) articles intended to be rubbed, poured, sprinkled, or sprayed

on, introduced into, or otherwise applied to the human body or any part thereof for cleansing,

beautifying, promoting attractiveness, or altering the appearance, and (2) articles intended for

use as a component of any such articles; except that such term shall not include soap.

(j) The term "official compendium" means the official United States Pharmacopeia, official

Homeopathic Pharmacopeia of the United States , official National Formulary, or any

supplement to any of them.

(k) The term "label" means a display of written, printed, or graphic matter upon the immediate

container of any article; and a requirement made by or under authority of this Act that any word,

statement, or other information appear on the label shall not be considered to be complied with

unless such word, statement, or other information also appears on the outside container or

wrapper, if any there be, of the retail package of such article, or is easily legible through the

outside container or wrapper.

(l) The term "immediate container" does not include package liners.

(m) The term "labeling" means all labels and other written, printed, or graphic matter (1) upon

any article or any of its containers or wrappers, or (2) accompanying such article.

(n) If an article is alleged to be misbranded because the labeling or advertising is misleading,

then in determining whether the labeling or advertising is misleading there shall be taken into

account (among other things) not only representations made or suggested by statement, word,

design, device, or any combination thereof, but also the extent to which the labeling or

advertising fails to reveal facts material in the light of such representations or material with

respect to consequences which may result from the use of the article to which the labeling or

advertising relates under the conditions of use prescribed in the labeling or advertising thereof

or under such conditions of use as are customary or usual.

(o) The representation of a drug, in its labeling, as an antiseptic shall be considered to be a

representation that it is a germicide, except in the case of a drug purporting to be, or

represented as, an antiseptic for inhibitory use as a wet dressing, ointment, dusting powder, or

such other use as involves prolonged contact with the body.

(p) 3 The term "new drug" means—

(1) Any drug (except a new animal drug or an animal feed bearing or containing a new animal

drug) the composition of which is such that such drug is not generally recognized, among

experts qualified by scientific training and experience to evaluate the safety and effectiveness

of drugs, as safe and effective for use under the conditions prescribed, recommended, or

suggested in the labeling thereof, except that such a drug not so recognized shall not be

deemed to be a "new drug" if at any time prior to the enactment of this Act it was subject to the

Food and Drugs Act of June 30, 1906, as amended, and if at such time its labeling contained

the same representations concerning the conditions of its use; or

(2) Any drug (except a new animal drug or an animal feed bearing or containing a new animal

drug) the composition of which is such that such drug, as a result of investigations to

determine its safety and effectiveness for use under such conditions, has become so

recognized, but which has not, otherwise than in such investigations, been used to a material

extent or for a material time under such conditions.

(q)(1)(A) Except as provided in clause (B), the term "pesticide chemical" means any substance

that is a pesticide within the meaning of the Federal Insecticide, Fungicide, and Rodenticide

Act, including all active and inert ingredients of such pesticide. Notwithstanding any other

provision of law, the term 'pesticide' within such meaning includes ethylene oxide and

propylene oxide when such substances are applied on food.

(B) In the case of the use, with respect to food, of a substance described in clause (A) to

prevent, destroy, repel, or mitigate microorganisms (including bacteria, viruses, fungi, protozoa,

algae, and slime), the following applies for purposes of clause (A):

(i) The definition in such clause for the term "pesticide chemical" does not include the

substance if the substance is applied for such use on food, or the substance is included for

such use in water that comes into contact with the food, in the preparing, packing, or holding of

the food for commercial purposes. The substance is not excluded under this subclause from

such definition if the substance is ethylene oxide or propylene oxide, and is applied for such

use on food. The substance is not so excluded if the substance is applied for such use on a

raw agricultural commodity, or the substance is included for such use in water that comes into

contact with the commodity, as follows:

(I) The substance is applied in the field.

(II) The substance is applied at a treatment facility where raw agricultural commodities are the

only food treated, and the treatment is in a manner that does not change the status of the food

as a raw agricultural commodity (including treatment through washing, waxing, fumigating, and

packing such commodities in such manner).

(III) The substance is applied during the transportation of such commodity between the field

and such a treatment facility.

(ii) The definition in such clause for the term "pesticide chemical" does not include the

substance if the substance is a food contact substance as defined in section 409(h)(6), and

any of the following circumstances exist: The substance is included for such use in an object

that has a food contact surface but is not intended to have an ongoing effect on any portion of

the object; the substance is included for such use in an object that has a food contact surface

and is intended to have an ongoing effect on a portion of the object but not on the food contact

surface; or the substance is included for such use in or is applied for such use on food

packaging (without regard to whether the substance is intended to have an ongoing effect on

any portion of the packaging). The food contact substance is not excluded under this

subclause from such definition if any of the following circumstances exist: The substance is

applied for such use on a semipermanent or permanent food contact surface (other than being

applied on food packaging); or the substance is included for such use in an object that has a

semipermanent or permanent food contact surface (other than being included in food

packaging) and the substance is intended to have an ongoing effect on the food contact

surface.

With respect to the definition of the term "pesticide" that is applicable to the Federal Insecticide,

Fungicide, and Rodenticide Act, this clause does not exclude any substance from such

definition.

(2) The term "pesticide chemical residue" means a residue in or on raw agricultural commodity

or processed food of—

(A) a pesticide chemical; or

(B) any other added substance that is present on or in the commodity or food primarily as a

result of the metabolism or other degradation of a pesticide chemical.

(3) Notwithstanding subparagraphs (1) and (2), the Administrator may by regulation except a

substance from the definition of "pesticide chemical" or "pesticide chemical residue" if—

(A) its occurrence as a residue on or in a raw agricultural commodity or processed food is

attributable primarily to natural causes or to human activities not involving the use of any

substances for a pesticidal purpose in the production, storage, processing, or transportation of

any raw agricultural commodity or processed food; and

(B) the Administrator, after consultation with the Secretary, determines that the substance

more appropriately should be regulated under one or more provisions of this Act other than

sections 402(a)(2)(B) and 408.

(r) The term "raw agricultural commodity" means any food in its raw or natural state, including

all fruits that are washed, colored, or otherwise treated in their unpeeled natural form prior to

marketing.

(s) The term "food additive" means any substance the intended use of which results or may

reasonably be expected to result, directly or indirectly, in its becoming a component or

otherwise affecting the characteristics of any food (including any substance intended for use in

producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or

holding food; and including any source of radiation intended for any such use), if such

substance is not generally recognized, among experts qualified by scientific training and

experience to evaluate its safety, as having been adequately shown through scientific

procedures (or, in the case of a substance used in food prior to January 1, 1958, through either

scientific procedures or experience based on common use in food) to be safe under the

conditions of its intended use; except that such term does not include—

(1) a pesticide chemical residue in or on a raw agricultural commodity or processed food; or

(2) a pesticide chemical; or

(3) a color additive; or

(4) any substance used in accordance with a sanction or approval granted prior to the

enactment of this paragraph 4 pursuant to this Act, the Poultry Products Inspection Act (21

U.S.C. 451 and the following) or the Meat Inspection Act of March 4, 1907 (34 Stat. 1260), as

amended and extended (21 U.S.C. 71 and the following);

(5) a new animal drug; or

(6) an ingredient described in paragraph (ff) in, or intended for use in, a dietary supplement.

(t)(1) The term "color additive" means a material which—

(A) is a dye, pigment, or other substance made by a process of synthesis or similar artifice, or

extracted, isolated, or otherwise derived, with or without intermediate or final change of identity,

from a vegetable, animal, mineral, or other source, and

(B) when added or applied to a food, drug, or cosmetic, or to the human body or any part

thereof, is capable (alone or through reaction with other substance) of imparting color thereto;

except that such term does not include any material which the Secretary, by regulation,

determines is used (or intended to be used) solely for a purpose or purposes other than

coloring.

(2) The term "color" includes black, white, and intermediate grays.

(3) Nothing in subparagraph (1) of this paragraph shall be construed to apply to any pesticide

chemical, soil or plant nutrient, or other agricultural chemical solely because of its effect in

aiding, re other natural physiological processes of produce of the soil and thereby affecting its

color, whether before or after harvest.

(u) The term "safe," as used in paragraph (s) of this section and in sections 409, 512, 571, and

721, has reference to the health of man or animal.

(v) The term "new animal drug" means any drug intended for use for animals other than man,

including any drug intended for use in animal feed but not including such animal feed—

(1) the composition of which is such that such drug is not generally recognized, among experts

qualified by scientific training and experience to evaluate the safety and effectiveness of

animal drugs, as safe and effective for use under the conditions prescribed, recommended, or

suggested in the labeling thereof; except that such a drug not so recognized shall not be

deemed to be a "new animal drug" if at any time prior to June 25, 1938, it was subject to the

Food and Drug Act of June 30, 1906, as amended, and if at such time its labeling contained

the same representations concerning the conditions of its use; or

(2) the composition of which is such that such drug, as a result of investigations to determine

its safety and effectiveness for use under such conditions, has become so recognized but

which has not, otherwise than in such investigations, been used to a material extent or for a

material time under such conditions.

Provided that 5 any drug intended for minor use or use in a minor species that is not the

subject of a final regulation published by the Secretary through notice and comment

rulemaking finding that the criteria of paragraphs (1) and (2) have not been met (or that the

exception to the criterion in paragraph (1) has been met) is a new animal drug.

(w) The term "animal feed", as used in paragraph (w) 6 of this section, in section 512, and in

provisions of this Act referring to such paragraph or section, means an article which is

intended for use for food for animals other than man and which is intended for use as a

substantial source of nutrients in the diet of the animal, and is not limited to a mixture intended

to be the sole ration of the animal.

(x) The term "informal hearing" means a hearing which is not subject to section 554, 556, or

557 of title 5 of the United States Code and which provides for the following:

(1) The presiding officer in the hearing shall be designated by the Secretary from officers and

employees of the Department who have not participated in any action of the Secretary which is

the subject of the hearing and who are not directly responsible to an officer or employee of the

Department who has participated in any such action.

(2) Each party to the hearing shall have the right at all times to be advised and accompanied

by an attorney.

(3) Before the hearing, each party to the hearing shall be given reasonable notice of the

matters to be considered at the hearing, including a comprehensive statement of the basis for

the action taken or proposed by the Secretary which is the subject of the hearing and a general

summary of the information which will be presented by the Secretary at the hearing in support

of such action.

(4) At the hearing the parties to the hearing shall have the right to hear a full and complete

statement of the action of the Secretary which is the subject of the hearing together with the

information and reasons supporting such action, to conduct reasonable questioning, and to

present any oral or written information relevant to such action.

(5) The presiding officer in such hearing shall prepare a written report of the hearing to which

shall be attached all written material presented at the hearing. The participants in the hearing

shall be given the opportunity to review and correct or supplement the presiding officer's report

of the hearing.

(6) The Secretary may require the hearing to be transcribed. A party to the hearing shall have

the right to have the hearing transcribed at his expense. Any transcription of a hearing shall be

included in the presiding officer's report of the hearing.

(y) The term "saccharin" includes calcium saccharin, sodium saccharin, and ammonium

saccharin.

(z) The term "infant formula" means a food which purports to be or is represented for special

dietary use solely as a food for infants by reason of its simulation of human milk or its suitability

as a complete or partial substitute for human milk.

(aa) The term "abbreviated drug application" means an application submitted under section

505(j) for the approval of a drug that relies on the approved application of another drug with the

same active ingredient to establish safety and efficacy, and—

(1) in the case of section 306, includes a supplement to such an application for a different or

additional use of the drug but does not include a supplement to such an application for other

than a different or additional use of the drug, and

(2) in the case of sections 307 and 308, includes any supplement to such an application.

(bb) The term "knowingly" or "knew" means that a person, with respect to information—

(1) has actual knowledge of the information, or

(2) acts in deliberate ignorance or reckless disregard of the truth or falsity of the information.

(cc) For purposes of section 306, the term "high managerial agent"—

(1) means—

(A) an officer or director of a corporation or an association,

(B) a partner of a partnership, or

(C) any employee or other agent of a corporation, association, or partnership, having duties

such that the conduct of such officer, director, partner, employee, or agent may fairly be

assumed to represent the policy of the corporation, association, or partnership, and

(2) includes persons having management responsibility for—

(A) submissions to the Food and Drug Administration regarding the development or approval

of any drug product, any drug product, or

(B) production, quality assurance, or quality control of any drug product, or

(C) research and development of any drug product.

(dd) For purposes of sections 306 and 307, the term "drug product" means a drug subject to

regulation under section 505, 512, or 802 of this Act or under section 351 of the Public Health

Service Act.

(ee) The term "Commissioner" means the Commissioner of Food and Drugs.

(ff) The term "dietary supplement"—

(1) means a product (other than tobacco) intended to supplement the diet that bears or

contains one or more of the following dietary ingredients:

(A) a vitamin;

(B) a mineral;

(C) an herb or other botanical;

(D) an amino acid;

(E) a dietary substance for use by man to supplement the diet by increasing the total dietary

intake; or

(F) a concentrate, metabolite, constituent, extract, or combination of any ingredient described

in clause (A), (B), (C), (D), or (E);

(2) means a product that—

(A)(i) is intended for ingestion in a form described in section 411(c)(1)(B)(i); or

(ii) complies with section 411(c)(1)(B)(ii);

(B) is not represented for use as a conventional food or as a sole item of a meal or the diet;

and

(C) is labeled as a dietary supplement; and

(3) does—

(A) include an article that is approved as a new drug under section 505 or licensed as a

biologic under section 351 of the Public Health Service Act (42 U.S.C. 262) and was, prior to

such approval, certification, or license, marketed as a dietary supplement or as a food unless

the Secretary has issued a regulation, after notice and comment, finding that the article, when

used as or in a dietary supplement under the conditions of use and dosages set forth in the

labeling for such dietary supplement, is unlawful under section 402(f); and

(B) not include—

(i) an article that is approved as a new drug under section 505, certified as an antibiotic under

section 507 7, or licensed as a biologic under section 351 of the Public Health Service Act (42

U.S.C. 262), or

(ii) an article authorized for investigation as a new drug, antibiotic, or biological for which

substantial clinical investigations have been instituted and for which the existence of such

investigations has been made public, which was not before such approval, certification,

licensing, or authorization marketed as a dietary supplement or as a food unless the Secretary,

in the Secretary's discretion, has issued would be lawful under this Act.

Except for purposes of section 201(g), a dietary supplement shall be deemed to be a food

within the meaning of this Act.

(gg) The term "processed food" means any food other than a raw agricultural commodity and

includes any raw agricultural commodity that has been subject to processing, such as canning,

cooking, freezing, dehydration, or milling.

(hh) The term "Administrator" means the Administrator of the United States Environmental

Protection Agency.

(ii) The term "compounded positron emission tomography drug"—

(1) means a drug that—

(A) exhibits spontaneous disintegration of unstable nuclei by the emission of positrons and is

used for the purpose of providing dual photon positron emission tomographic diagnostic

images; and

(B) has been compounded by or on the order of a practitioner who is licensed by a State to

compound or order compounding for a drug described in subparagraph (A), and is

compounded in accordance with that State's law, for a patient or for research, teaching, or

quality control; and

(2) includes any nonradioactive reagent, reagent kit, ingredient, nuclide generator, accelerator,

target material, electronic synthesizer, or other apparatus or computer program to be used in

the preparation of such a drug.

(jj) The term "antibiotic drug" means any drug (except drugs for use in animals other than

humans) composed wholly or partly of any kind of penicillin, streptomycin, chlortetracycline,

chloramphenicol, bacitracin, or any other drug intended for human use containing any quantity

of any chemical substance which is produced by a micro-organism and which has the capacity

to inhibit or destroy micro-organisms in dilute solution (including a chemically synthesized

equivalent of any such substance) or any derivative thereof.

(kk) 8 Priority Supplement- The term "priority supplement" means a drug application referred

to in section 101(4) of the Food and Drug Administration Modernization Act of 1997 (111 Stat.

2298).

(ll)(1) The term "single-use device" means a device that is intended for one use, or on a single

patient during a single procedure.

(2)(A) The term "reprocessed", with respect to a single-use device, means an original device

that has previously been used on a patient and has been subjected to additional processing

and manufacturing for the purpose of an additional single use on a patient. The subsequent

processing and manufacture of a reprocessed single-use device shall result in a device that is

reprocessed within the meaning of this definition.

(B) A single-use device that meets the definition under clause (A) shall be considered a

reprocessed device without regard to any description of the device used by the manufacturer

of the device or other persons, including a description that uses the term "recycled" rather than

the term "reprocessed".

(3) The term "original device" means a new, unused single-use device.

(mm)(1) The term "critical reprocessed single-use device" means a reprocessed single-use

device that is intended to contact normally sterile tissue or body spaces during use.

(2) The term "semi-critical reprocessed single-use device" means a reprocessed single-use

device that is intended to contact intact mucous membranes and not penetrate normally sterile

areas of the body.

(nn) The term "major species" means cattle, horses, swine, chickens, turkeys, dogs, and cats,

except that the Secretary may add species to this definition by regulation.

(oo) The term "minor species" means animals other than humans that are not major species.

(pp) The term "minor use" means the intended use of a drug in a major species for an

indication that occurs infrequently and in only a small number of animals or in limited

geographical areas and in only a small number of animals annually.

(qq) The term "major food allergen" means any of the following:

(1) Milk, egg, fish (e.g., bass, flounder, or cod), Crustacean shellfish (e.g., crab, lobster, or

shrimp), tree nuts (e.g., almonds, pecans, or walnuts), wheat, peanuts, and soybeans.

(2) A food ingredient that contains protein derived from a food specified in paragraph 9 (1),

except the following:

(A) Any highly refined oil derived from a food specified in paragraph (1) and any ingredient

derived from such highly refined oil.

(B) A food ingredient that is exempt under paragraph (6) or (7) of section 403(w).

Footnotes: Chapter II

1. The following additional definitions applicable to this Act are provided for in other Acts:

Butter. The Act of March 4, 1923 (21 U.S.C. 321a), defines butter as "the food product usually

known as butter, and which is made exclusively from milk or cream, or both, with or without

common salt, and with or without additional coloring matter, and containing not less than 80

per centum by weight of milk fat, all tolerances having been allowed for."

Package. The Act of July 24, 1919 (21 U.S.C. 321b), states "The word 'package' shall include

and shall be construed to include wrapped meats inclosed in papers or other materials as

prepared by the manufacturers thereof for sale."

Nonfat Dry Milk, Milk. The Act of July 2, 1956 (21 U.S.C. 321c), defines nonfat dry milk as "the

product resulting from the removal of fat and water from milk, and contains the lactose, milk

proteins, and milk minerals in the same relative proportions as in the fresh milk from which

made. It contains not over 5 per centum by weight of moisture. The fat content is not over 11⁄2

per centum by weight unless otherwise indicated.", and defines milk to mean sweet milk of

cows.

2. See footnote for section 403(h)(3) regarding the stylistic use of a list consisting of "(a)",

"(b)", etc.

3. The amendments made to this Act by the Drug Amendments of 1962 included amendments

establishing the requirement that new drugs be effective. Section 107(c) of such Public Law

concerned the applicability of the amendments, and is included in the appendix to this

compilation.

4. Paragraph (s) was added by Public Law 85–929, which was enacted September 6, 1958.

5. The proviso appears so as to reflect the probable intent of the Congress. See section

102(b)(5)(B) of Public Law 108–282, which in amending section 201(v) above referred to

"paragraph (2)" of the section. The reference probably should have been to "subparagraph (2)".

(See

footnote for section 403(h)(3) regarding the stylistic use of a list consisting of "(a)", "(b)", etc.)

With respect to the placement of the proviso, section 102(b)(5)(B) of such Public Law provided

for placement "after" paragraph (2) (not at the end of paragraph (2)), yet did not indicate

separate

indentation. The proviso has been placed after and below subparagraph (2), with separate

indentation, to indicate the probable intent of the Congress, although such placement of matter

that is not a complete sentence calls for striking the period at the end of subparagraph (2) and

inserting a semicolon, which section 102(b)(5)(B) of such Public Law did not do. (Compare

with

matter after and below section 201(t)(1)(B), for example.)

6. So in law. Probably should be paragraph "(v)".

7. So in law. Section 507 was repealed by section 125(b)(1) of Public Law 105–115 (111 Stat.

2325).

8. Indentation is so in law. See section 5(b)(1) of Public Law 107–109 (115 Stat. 1413).

9. So in law. See section 203(c)(1) of Public Law 108–282. Probably should be

"subparagraph". See footnote for section 403(h)(3).

CHAPTER III—PROHIBITED ACTS AND PENALTIES

PROHIBITED ACTS

SEC. 301. [ 21 U.S.C. 331] [Caution: See prospective amendment note below.] The

following acts and the causing thereof are hereby prohibited: 1

(a) The introduction or delivery for introduction into interstate commerce of any food, drug,

device, or cosmetic that is adulterated or misbranded.

(b) The adulteration or misbranding of any food, drug, device, or cosmetic in interstate

commerce.

(c) The receipt in interstate commerce of any food, drug, device, or cosmetic that is

adulterated or misbranded, and the delivery or proffered delivery thereof for pay or otherwise.

(d) The introduction or delivery for introduction into interstate commerce of any article in

violation of section 404, 505 or 564.

(e) The refusal to permit access to or copying of any record as required by section 412, 414,

416, 504, 564, 703 or 704(a); or the failure to establish or maintain any record, or make any

report, required under section 412, 414(b), 416, 504, 505(i) or (k), 512(a)(4)(C), 512 (j), (l) or

(m), 572(i), 2 515(f), 519, or 564, or the refusal to permit access to or verification or copying of

any such required record.

(f) The refusal to permit entry or inspection as authorized by section 704.

(g) The manufacture, within any Territory of any food, drug, device, or cosmetic that is

adulterated or misbranded.

(h) The giving of a guaranty or undertaking referred to in section 333(c)(2), which guaranty or

undertaking is false, except by a person who relied upon a guaranty or undertaking to the

same effect signed by, containing the name and address of, the person residing in the United

States from whom he received in good faith the food, drug, device, or cosmetic; or the giving of

a guaranty or undertaking referred to in section 333(c)(3), which guaranty or undertaking is

false.

(i) (1) Forging, counterfeiting, simulating, or falsely representing, or without proper authority

using any mark, stamp, tag, label, or other identification device authorized or required by

regulations promulgated under the provisions of section 404, or 721.

(2) Making, selling, disposing of, or keeping in possession, control, or custody, or concealing

any punch, die, plate, stone, or other thing designed to print, imprint, or reproduce the

trademark, trade name, or other identifying mark, imprint, or device of another or any likeness

of any of the foregoing upon any drug or container or labeling thereof so as to render such

drug a counterfeit drug.

(3) The doing of any act which causes a drug to be a counterfeit drug, or the sale or dispensing,

or the holding for sale or dispensing, of a counterfeit drug.

(j) The using by any person to his own advantage, or revealing, other than to the Secretary or

officers or employees of the Department, or to the courts when relevant in any judicial

proceeding under this Act, any information acquired under authority of section 404, 409, 412,

414, 505, 510, 512, 513, 514, 515, 516, 518, 519, 520, 571, 572, 573 , 3 704, 708, or 721

concerning any method or process which as a trade secret is entitled to protection; or the

violating of section 408(i)(2) or any regulation issued under that section. 4 This paragraph

does not authorize the withholding of information from either House of Congress or from, to the

extent of matter within its jurisdiction, any committee or subcommittee of such committee or

any joint committee of Congress or any subcommittee of such joint committee.

(k) The alteration, mutilation, destruction, obliteration, or removal of the whole or any part of

the labeling of, or the doing of any other act with respect to, a food, drug, device, or cosmetic, if

such act is done while such article is held for sale (whether or not the first sale) after shipment

in interstate commerce and results in such article being adulterated or misbranded.

(l) [Deleted] 5

(m) The sale or offering for sale of colored oleomargarine or colored margarine, or the

possession or serving of colored oleomargarine or colored margarine in violation of sections

407(b) or 407(c).

(n) The using, in labeling, advertising or other sales promotion of any reference to any report or

analysis furnished in compliance with section 704.

(o) In the case of a prescription drug distributed or offered for sale in interstate commerce, the

failure of the manufacturer, packer, or distributor thereof to maintain for transmittal, or to

transmit, to any practitioner licensed by applicable State law to administer such drug who

makes written request for information as to such drug, true and correct copies of all printed

matter which is required to be included in any package in which that drug is distributed or sold,

or such other printed matter as is approved by the Secretary. Nothing in this paragraph shall

be construed to exempt any person from any labeling requirement imposed by or under other

provisions of this Act .

(p) The failure to register in accordance with section 510, the failure to provide any information

required by section 510(j) or 510(k), 21 USC § 360(j) or (k)] or the failure to provide a notice

required by section 510(j)(2).

(q)(1) The failure or refusal to (A) comply with any requirement prescribed under section 518

or 520(g), (B) furnish any notification or other material or information required by or under

section 519 or 520(g), or (C) comply with a requirement under section 522.

(2) With respect to any device, the submission of any report that is required by or under this

Act that is false or misleading in any material respect.

(r) The movement of a device in violation of an order under section 304(g) or the removal or

alteration of any mark or label required by the order to identify the device as detained.

(s) The failure to provide the notice required by section 412(c) or 412(e), the failure to make

the reports required by section 412(f)(1)(B), the failure to retain the records required by section

412(b)(4), or the failure to meet the requirements prescribed under section 412(f)(3).

(t) The importation of a drug in violation of section 801(d)(1) , the sale, purchase, or trade of a

drug or drug sample or the offer to sell, purchase, or trade a drug or drug sample in violation of

section 503(c), the sale, purchase, or trade of a coupon, the offer to sell, purchase, or trade

such a coupon, or the counterfeiting of such a coupon in violation of section 503(c)(2), the

distribution of a drug sample in violation of section 503(d) or the failure to otherwise comply

with the requirements of section 503(d), or the distribution of drugs in violation of section 503(e)

or the failure to otherwise comply with the requirements of section 503(e).

(u) The failure to comply with any requirements of the provisions of, or any regulations or

orders of the Secretary, under section 512(a)(4)(A), 512(a)(4)(D), or 512(a)(5).

(v) The introduction or delivery for introduction into interstate commerce of a dietary

supplement that is unsafe under section 413.

(w) The making of a knowingly false statement in any statement, certificate of analysis, record,

or report required or requested under section 801(d)(3); the failure to submit a certificate of

analysis as required under such section; the failure to maintain records or to submit records or

reports as required by such section; the release into interstate commerce of any article or

portion thereof imported into the United States under such section or any finished product

made from such article or portion, except for export in accordance with section 801(e) or 802,

or with section 351(h) of the Public Health Service Act [42 USC § 262(h)]; or the failure to so

export or to destroy such an article or portions thereof, or such a finished product.

(x) The falsification of a declaration of conformity submitted under section 514(c) or the failure

or refusal to provide data or information requested by the Secretary under paragraph (3) of

such section.

(y) In the case of a drug, device, or food –

(1) the submission of a report or recommendation by a person accredited under section 523

that is false or misleading in any material respect;

(2) the disclosure by a person accredited under section 523 of confidential commercial

information or any trade secret without the express written consent of the person who

submitted such information or secret to such person; or

(3) the receipt by a person accredited under section 523 of a bribe in any form or the doing of

any corrupt act by such person associated with a responsibility delegated to such person

under this Act.

(z) [Caution: This subsection terminated Sept. 30, 2006, pursuant to § 401(e) of Act Nov.

21, 1997, P.L. 105-115.] 6 The dissemination of information in violation of section 551.

( aa) The importation of a prescription drug in violation of section 804, the falsification of any

record required to be maintained or provided to the Secretary under section, or any other

violation of regulations under such section.

(bb) The transfer of an article of food in violation of an order under section 304(h), or the

removal or alteration of any mark or label required by the order to identify the article as

detained.

(cc) The importing or offering for import into the United States of an article of food by, with the

assistance of, or at the direction of, a person debarred under section 306(b)(3).

( dd) The failure to register in accordance with section 415.

( ee) The importing or offering for import into the United States of an article of food in violation

of the requirements under section 801(m).

(ff) The importing or offering for import into the United States of a drug or device with respect to

which there is a failure to comply with a request of the Secretary to submit to the Secretary a

statement under section 801(o).

(gg) The knowing failure to comply with paragraph (7)(E) of section 704(g); the knowing

inclusion by a person accredited under paragraph (2) of such section of false information in an

inspection report under paragraph (7)(A) of such section; or the knowing failure of such a

person to include material facts in such a report.

(hh) The failure by a shipper, carrier by motor vehicle or rail vehicle, receiver, or any other

person engaged in the transportation of food to comply with the sanitary transportation

practices prescribed by the Secretary under section 416.

(ii) [Caution: This subsection is effective 1 year after enactment, pursuant to § 4(b) of

Act Dec. 22, 2006, P.L. 109-462.] The falsification of a report of a serious adverse event

submitted to a responsible person (as defined under section 760 or 761) or the falsification of a

serious adverse event report (as defined under section 760 or 761) submitted to the Secretary.

INJUNCTION PROCEEDINGS

SEC. 302 [21 U.S.C. 332] (a) The district courts of the United States and the United States

courts of the Territories shall have jurisdiction, for cause shown 7 to restrain violations of

section 301, except paragraphs (h), (i), and (j).

(b) In case of violation of an injunction or restraining order issued under this section, which

also constitutes a violation of this Act, trial shall be by the court, or, upon demand of the

accused, by a jury.

PENALTIES

SEC. 303. [21 U.S.C. 333] (a)(1) Any person who violates a provision of section 301 shall be

imprisoned for not more than one year or fined not more than $1,000, or both.

(2) Notwithstanding the provisions of paragraph (1) of this section, if any person commits such

a violation after a conviction of him under this section has become final, or commits such a

violation with the intent to defraud or mislead, such person shall be imprisoned for not more

than three years or fined not more than $10,000 or both.

(b)(1) Notwithstanding subsection (a), any person who violates section 301(t) by—

(A) knowingly importing a drug in violation of section 801(d)(1),

(B) knowingly selling, purchasing, or trading a drug or drug sample or knowingly offering to sell,

purchase, or trade a drug or drug sample, in violation of section 503(c)(1),

(C) knowingly selling, purchasing, or trading a coupon, knowingly offering to sell, purchase, or

trade such a coupon, or knowingly counterfeiting such a coupon, in violation of section

503(c)(2), or

(D) knowingly distributing drugs in violation of section 503(e)(2)(A), shall be imprisoned for not

more than 10 years or fined not more than $250,000, or both.

(2) Any manufacturer or distributor who distributes drug samples by means other than the mail

or common carrier whose representative, during the course of the representative’s

employment or association with that manufacturer or distributor, violated section 301(t)

because of a violation of section 503(c)(1) or violated any State law prohibiting the sale,

purchase, or trade of a drug sample subject to section 503(b) or the offer to sell, purchase, or

trade such a drug sample shall, upon conviction of the representative for such violation, be

subject to the following civil penalties:

(A) A civil penalty of not more than $50,000 for each of the first two such violations resulting in

a conviction of any representative of the manufacturer or distributor in any 10-year period.

(B) A civil penalty of not more than $1,000,000 for each violation resulting in a conviction of

any representative after the second conviction in any 10-year period.

For the purposes of this paragraph, multiple convictions of one or more persons arising out of

the same event or transaction, or a related series of events or transactions, shall be

considered as one violation.

(3) Any manufacturer or distributor who violates section 301(t) because of a failure to make a

report required by section 503(d)(3)(E) shall be subject to a civil penalty of not more than

$100,000.

(4)(A) If a manufacturer or distributor or any representative of such manufacturer or distributor

provides information leading to the institution of a criminal proceeding against, and conviction

of, any representative of that manufacturer or distributor for a violation of section 301(t)

because of a sale, purchase, or trade or offer to purchase, sell, or trade a drug sample in

violation of section 503(c)(1) or for a violation of State law prohibiting the sale, purchase, or

trade or offer to sell, purchase, or trade a drug sample, the conviction of such representative

shall not be considered as a violation for purposes of paragraph (2).

(B) If, in an action brought under paragraph (2) against a manufacturer or distributor relating to

the conviction of a representative of such manufacturer or distributor for the sale, purchase, or

trade of a drug or the offer to sell, purchase, or trade a drug, it is shown, by clear and

convincing evidence—

(i) that the manufacturer or distributor conducted, before the institution of a criminal proceeding

against such representative for the violation which resulted in such conviction, an investigation

of events or transactions which would have led to the reporting of information leading to the

institution of a criminal proceeding against, and conviction of, such representative for such

purchase, sale, or trade or offer to purchase, sell, or trade, or

(ii) that, except in the case of the conviction of a representative employed in a supervisory

function, despite diligent implementation by the manufacturer or distributor of an independent

audit and security system designed to detect such a violation, the manufacturer or distributor

could not reasonably have been expected to have detected such violation, the conviction of

such representative shall not be considered as a conviction for purposes of paragraph (2).

(5) If a person provides information leading to the institution of a criminal proceeding against,

and conviction of, a person for a violation of section 301(t) because of the sale, purchase, or

trade of a drug sample or the offer to sell, purchase, or trade a drug sample in violation of

section 503(c)(1), such person shall be entitled to one-half of the criminal fine imposed and

collected for such violation but not more than $125,000.

(6) Notwithstanding subsection (a), any person who is a manufacturer or importer of a

prescription drug under section 804(b) and knowingly fails to comply with a requirement of

section 804(e) that is applicable to such manufacturer or importer, respectively, shall be

imprisoned for not more than 10 years or fined not more than $250,000, or both.

(c) No person shall be subject to the penalties of subsection (a)(1) of this section, (1) for

having received in interstate commerce any article and delivered it or proffered delivery of it, if

such delivery or proffer was made in good faith, unless he refuses to furnish on request of an

officer or employee duly designated by the Secretary the name and address of the person

from whom he purchased or received such article and copies of all documents, if any there be,

pertaining to the delivery of the article to him; or (2) for having violated section 301(a) or (d), if

he establishes a guaranty or undertaking signed by, and containing the name and address of,

the person residing in the United States from whom he received in good faith the article, to the

effect, in case of an alleged violation of section 301(a), that such article is not adulterated or

misbranded, within the meaning of this Act, designating this Act, or to the effect, in case of an

alleged violation of section 301(d), that such article is not an article which may not, under the

provisions of section 404 or 505, be introduced into interstate commerce; or (3) for having

violated section 301(a), where the violation exists because the article is adulterated by reason

of containing a color additive not from a batch certified in accordance with regulations

promulgated by the Secretary under this Act, if such person establishes a guaranty or

undertaking signed by, and containing the name and address of, the manufacturer of the color

additive, to the effect that such color additive was from a batch certified in accordance with the

applicable regulations promulgated by the Secretary under this Act; or (4) for having violated

section 301 (b), (c), or (k) by failure to comply with section 502(f) in respect to an article

received in interstate commerce to which neither section 503(a) nor section 503(b)(1) is

applicable, if the delivery or proffered delivery was made in good faith and the labeling at the

time thereof contained the same directions for use and warning statements as were contained

in the labeling at the time of such receipt of such article; or (5) for having violated section

301(i)(2) if such person acted in good faith and had no reason to believe that use of the punch,

die, plate, stone, or other thing involved would result in a drug being a counterfeit drug, or for

having violated section 301(i)(3) if the person doing the act or causing it to be done acted in

good faith and had no reason to believe that the drug was a counterfeit drug.

(d) No person shall be subject to the penalties of subsection (a)(1) of this section for a violation

of section 301 involving misbranded food if the violation exists solely because the food is

misbranded under section 403(a)(2) because of its advertising.

(e)(1) Except as provided in paragraph (2), whoever knowingly distributes, or possesses with

intent to distribute, human growth hormone for any use in humans other than the treatment of

a disease or other recognized medical condition, where such use has been authorized by the

Secretary of Health and Human Services under section 505 and pursuant to the order of a

physician, is guilty of an offense punishable by not more than 5 years in prison, such fines as

are authorized by title 18, United States Code, or both.

(2) Whoever commits any offense set forth in paragraph (1) and such offense involves an

individual under 18 years of age is punishable by not more than 10 years imprisonment, such

fines as are authorized by title 18, United States Code, or both.

(3) Any conviction for a violation of paragraphs (1) and (2) of this subsection shall be

considered a felony violation of the Controlled Substances Act for the purposes of forfeiture

under section 413 of such Act.

(4) As used in this subsection the term ‘‘human growth hormone’’ means somatrem,

somatropin, or an analogue of either of them.

(5) The Drug Enforcement Administration is authorized to investigate offenses punishable by

this subsection.

(f)(1) (A) 8 Except as provided in subparagraph (B), any person who violates a requirement of

this Act which relates to devices shall be liable to the United States for a civil penalty in an

amount not to exceed $15,000 for each such violation, and not to exceed $1,000,000 for all

such violations adjudicated in a single proceeding. For purposes of the preceding sentence, a

person accredited under paragraph (2) of section 704(g) who is substantially not in compliance

with the standards of accreditation under such section, or who poses a threat to public health

or fails to act in a manner that is consistent with the purposes of such section, shall be

considered to have violated a requirement of this Act that relates to devices.

(B) Subparagraph (A) shall not apply—

(i) to any person who violates the requirements of section 519(a) or 520(f) unless such

violation constitutes (I) a significant or knowing departure from such requirements, or (II) a risk

to public health,

(ii) to any person who commits minor violations of section 519(e) or 519(f) (only with respect to

correction reports) if such person demonstrates substantial compliance with such section, or

(iii) to violations of section 501(a)(2)(A) which involve one or more devices which are not

defective.

(2)(A) Any person who introduces into interstate commerce or delivers for introduction into

interstate commerce an article of food that is adulterated within the meaning of section

402(a)(2)(B) shall be subject to a civil money penalty of not more than $50,000 in the case of

an individual and $250,000 in the case of any other person for such introduction or delivery,

not to exceed $500,000 for all such violations adjudicated in a single proceeding.

(B) This paragraph shall not apply to any person who grew the article of food that is

adulterated. If the Secretary assesses a civil penalty against any person under this paragraph,

the Secretary may not use the criminal authorities under this section to sanction such person

for the introduction or delivery for introduction into interstate commerce of the article of food

that is adulterated. If the Secretary assesses a civil penalty against any person under this

paragraph, the Secretary may not use the seizure authorities of section 304 or the injunction

authorities of section 302 with respect to the article of food that is adulterated.

(C) In a hearing to assess a civil penalty under this paragraph, the presiding officer shall have

the same authority with regard to compelling testimony or production of documents as a

presiding officer has under section 408(g)(2)(B). The third sentence of paragraph (3)(A) shall

not apply to any investigation under this paragraph.

(3)(A) A civil penalty under paragraph (1) or (2) shall be assessed by the Secretary by an order

made on the record after opportunity for a hearing provided in accordance with this

subparagraph and section 554 of title 5, United States Code. Before issuing such an order, the

Secretary shall give written notice to the person to be assessed a civil penalty under such

order of the Secretary’s proposal to issue such order and provide such person an opportunity

for a hearing on the order. In the course of any investigation, the Secretary may issue

subpoenas requiring the attendance and testimony of witnesses and the production of

evidence that relates to the matter under investigation.

(B) In determining the amount of a civil penalty, the Secretary shall take into account the

nature, circumstances, extent, and gravity of the violation or violations and, with respect to the

violator, ability to pay, effect on ability to continue to do business, any history of prior such

violations, the degree of culpability, and such other matters as justice may require.

(C) The Secretary may compromise, modify, or remit, with or without conditions, any civil

penalty which may be assessed under paragraph (1) or (2). The amount of such penalty, when

finally determined, or the amount agreed upon in compromise, may be deducted from any

sums owing by the United States to the person charged.

(4) Any person who requested, in accordance with paragraph (3)(A), a hearing respecting the

assessment of a civil penalty and who is aggrieved by an order assessing a civil penalty may

file a petition for judicial review of such order with the United States Court of Appeals for the

District of Columbia Circuit or for any other circuit in which such person resides or transacts

business. Such a petition may only be filed within the 60-day period beginning on the date the

order making such assessment was issued.

(5) If any person fails to pay an assessment of a civil penalty—

(A) after the order making the assessment becomes final, and if such person does not file a

petition for judicial review of the order in accordance with paragraph (4), or

(B) after a court in an action brought under paragraph (4) has entered a final judgment in favor

of the Secretary, the Attorney General shall recover the amount assessed (plus interest at

currently prevailing rates from the date of the expiration of the 60-day period referred to in

paragraph (4) or the date of such final judgment, as the case may be) in an action brought in

any appropriate district court of the United States. In such an action, the validity, amount, and

appropriateness of such penalty shall not be subject to review.

SEIZURE

SEC. 304. [21 U.S.C. 334] (a) (1) Any article of food, drug, or cosmetic that is adulterated or

misbranded when introduced into or while in interstate commerce or while held for sale

(whether or not the first sale) after shipment in interstate commerce, or which may not, under

the provisions of section 404 or 505, be introduced into interstate commerce, shall be liable to

be proceeded against while in interstate commerce, or at any time thereafter, on libel of

information and condemned in any district court of the United States or United States court of a

Territory within the jurisdiction of which the article is found. No libel for condemnation shall be

instituted under this Act, for any alleged misbranding if there is pending in any court a libel for

condemnation proceeding under this Act based upon the same alleged misbranding, and not

more than one such proceeding shall be instituted if no such proceeding is so pending, except

that such limitations shall not apply (A) when such misbranding has been the basis of a prior

judgment in favor of the United States, in a criminal, injunction, or libel for condemnation

proceeding under this Act, or (B) when the Secretary has probable cause to believe from facts

found, without hearing, by him or any officer or employee of the Department that the

misbranded article is dangerous to health, or that the labeling of the misbranded article is

fraudulent, or would be in a material respect misleading to the injury or damage of the

purchaser or consumer. In any case where the number of libel for condemnation proceedings

is limited as above provided the proceeding pending or instituted shall, on application of the

claimant, seasonably made, be removed for trial to any district agreed upon by stipulation

between the parties, or, in case of failure to so stipulate within a reasonable time, the claimant

may apply to the court of the district in which the seizure has been made, and such court (after

giving the United States attorney for such district reasonable notice and opportunity to be

heard) shall by order, unless good cause to the contrary is shown, specify a district of

reasonable proximity to the claimant's principal place of business, to which the case shall be

removed for trial.

(2) The following shall be liable to be proceeded against at any time on libel of information and

condemned in any district court of the United States or United States court of a Territory within

the jurisdiction of which they are found: (A) Any drug that is a counterfeit drug, (B) Any

container of a counterfeit drug, (C) Any punch, die, plate, stone, labeling, container, or other

thing used or designed for use in making a counterfeit drug or drugs, and (D) Any adulterated

or misbranded device.

(3) (A) Except as provided in subparagraph (B), no libel for condemnation may be instituted

under paragraph (1) or (2) against any food which -

(i) is misbranded under section 403(a)(2) because of its advertising, and

(ii) is being held for sale to the ultimate consumer in an establishment other than an

establishment owned or operated by a manufacturer, packer, or distributor of the food.

(B) A libel for condemnation may be instituted under paragraph (1) or (2) against a food

described in subparagraph (A) if –

(i)(I) the food's advertising which resulted in the food being misbranded under section 403(a)(2)

was disseminated in the establishment in which the food is being held for sale to the ultimate

consumer,

(II) such advertising was disseminated by, or under the direction of, the owner or operator of

such establishment, or

(III) all or part of the cost of such advertising was paid by such owner or operator; and

(ii) the owner or operator of such establishment used such advertising in the establishment to

promote the sale of the food.

(b) The article, equipment, or other thing proceeded against shall be liable to seizure by

process pursuant to the libel, and the procedure in cases under this section shall conform, as

nearly as may be, to the procedure in admiralty; except that on demand of either party any

issue of fact joined in any such case shall be tried by jury. When libel for condemnation

proceedings under this section, involving the same claimant and the same issues of

adulteration or misbranding, are pending in two or more jurisdictions, such pending

proceedings, upon application of the claimant seasonably made to the court of one such

jurisdiction, shall be consolidated for trial by order of such court, and tried in (1) any district

selected by the claimant where one of such proceedings is pending; or (2) a district agreed

upon by stipulation between the parties. If no order for consolidation is so made within a

reasonable time, the claimant may apply to the court of one such jurisdiction and such court

(after giving the United States attorney for such district reasonable notice and opportunity to be

heard) shall by order, unless good cause to the contrary is shown, specify a district of

reasonable proximity to the claimant's principal place of business, in which all such pending

proceedings shall be consolidated for trial and tried. Such order of consolidation shall not apply

so as to require the removal of any case the date for trial of which has been fixed. The court

granting such order shall give prompt notification thereof to the other courts having jurisdiction

of the cases covered thereby.

(c) The court at any time after seizure up to a reasonable time before trial shall by order allow

any party to a condemnation proceeding, his attorney or agent, to obtain a representative

sample of the article seized and a true copy of the analysis, if any, on which the proceeding is

based and the identifying marks or numbers, if any, of the packages from which the samples

analyzed were obtained.

(d)(1) Any food, drug, device, or cosmetic condemned under this section shall, after entry of

the decree, be disposed of by destruction or sale as the court may, in accordance with the

provisions of this section, direct and the proceeds thereof, if sold, less the legal costs and

charges, shall be paid into the Treasury of the United States; but such article shall not be sold

under such decree contrary to the provisions of this Act or the laws of the jurisdiction in which

sold. After entry of the decree and upon the payment of the costs of such proceedings and the

execution of a good and sufficient bond conditioned that such article shall not be sold or

disposed of contrary to the provisions of this Act or the laws of any State or Territory in which

sold, the court may by order direct that such article be delivered to the owner thereof to be

destroyed or brought into compliance with the provisions of this Act, under the supervision of

an officer or employee duly designated by the Secretary, and the expenses of such

supervision shall be paid by the person obtaining release of the article under bond. If the article

was imported into the United States and the person seeking its release establishes (A) that the

adulteration, misbranding, or violation did not occur after the article was imported, and (B) that

he had no cause for believing that it was adulterated, misbranded, or in violation before it was

released from customs custody, the court may permit the article to be delivered to the owner

for exportation in lieu of destruction upon a showing by the owner that all of the conditions of

section 801(e) can and will be met. The provisions of this sentence shall not apply where

condemnation is based upon violation of section 402(a)(1), (2), or (6), section 501(a)(3),

section 502(j), or section 601(a) or (d). Where such exportation is made to the original foreign

supplier, then paragraphs (1) and (2) of section 801(e) and the preceding sentence shall not

be applicable; and in all cases of exportation the bond shall be conditioned that the article shall

not be sold or disposed of until the applicable conditions of section 801(e) have been met. Any

article condemned by reason of its being an article which may not, under section 404 or 505,

be introduced into interstate commerce, shall be disposed of by destruction.

(2) The provisions of paragraph (1) of this subsection shall, to the extent deemed appropriate

by the court, apply to any equipment or other thing which is not otherwise within the scope of

such paragraph and which is referred to in paragraph (2) of subsection (a).

(3) Whenever in any proceeding under this section, involving paragraph (2) of subsection (a),

the condemnation of any equipment or thing (other than a drug) is decreed, the court shall

allow the claim of any claimant, to the extent of such claimant's interest, for remission or

mitigation of such forfeiture if such claimant proves to the satisfaction of the court (i) that he

has not committed or caused to be committed any prohibited act referred to in such paragraph

(2) and has no interest in any drug referred to therein, (ii) that he has an interest in such

equipment or other thing as owner or lienor or otherwise, acquired by him in good faith, and (iii)

that he at no time had any knowledge or reason to believe that such equipment or other thing

was being or would be used in, or to facilitate, the violation of laws of the United States relating

to counterfeit drugs.

(e) When a decree of condemnation is entered against the article, court costs and fees, and

storage and other proper expenses, shall be awarded against the person, if any, intervening as

claimant of the article.

(f) In the case of removal for trial of any case as provided by subsection (a) or (b) -

(1) The clerk of the court from which removal is made shall promptly transmit to the court in

which the case is to be tried all records in the case necessary in order that such court may

exercise jurisdiction.

(2) The court to which such case was removed shall have the powers and be subject to the

duties, for purposes of such case, which the court from which removal was made would have

had, or to which such court would have been subject, if such case had not been removed.

(g)(1) If during an inspection conducted under section 704 of a facility or a vehicle, a device

which the officer or employee making the inspection has reason to believe is adulterated or

misbranded is found in such facility or vehicle, such officer or employee may order the device

detained (in accordance with regulations prescribed by the Secretary) for a reasonable period

which may not exceed twenty days unless the Secretary determines that a period of detention

greater than twenty days is required to institute an action under subsection (a) or section 302,

in which case he may authorize a detention period of not to exceed thirty days. Regulations of

the Secretary prescribed under this paragraph shall require that before a device may be

ordered detained under this paragraph the Secretary or an officer or employee designated by

the Secretary approve such order. A detention order under this paragraph may require the

labeling or marking of a device during the period of its detention for the purpose of identifying

the device as detained. Any person who would be entitled to claim a device if it were seized

under subsection (a) may appeal to the Secretary a detention of such device under this

paragraph. Within five days of the date an appeal of a detention is filed with the Secretary, the

Secretary shall after affording opportunity for an informal hearing by order confirm the

detention or revoke it.

(2)(A) Except as authorized by subparagraph (B), a device subject to a detention order issued

under paragraph (1) shall not be moved by any person from the place at which it is ordered

detained until –

(i) released by the Secretary, or

(ii) the expiration of the detention period applicable to such order, whichever occurs first.

(B) A device subject to a detention order under paragraph (1) may be moved –

(i) in accordance with regulations prescribed by the Secretary, and

(ii) if not in final form for shipment, at the discretion of the manufacturer of the device for the

purpose of completing the work required to put it in such form.

(h) Administrative Detention of Foods.—

(1) Detention authority.--

(A) In general.--An officer or qualified employee of the Food and Drug Administration may

order the detention, in accordance with this subsection, of any article of food that is found

during an inspection, examination, or investigation under this Act conducted by such officer or

qualified employee, if the officer or qualified employee has credible evidence or information

indicating that such article presents a threat of serious adverse health consequences or death

to humans or animals.

(B) Secretary's approval.--An article of food may be ordered detained under subparagraph (A)

only if the Secretary or an official designated by the Secretary approves the order. An official

may not be so designated unless the official is the director of the district under this Act in which

the article involved is located, or is an official senior to such director.

(2) Period of detention.--An article of food may be detained under paragraph (1) for a

reasonable period, not to exceed 20 days, unless a greater period, not to exceed 30 days, is

necessary, to enable the Secretary to institute an action under subsection (a) or section

302. The Secretary shall by regulation provide for procedures for instituting such action on an

expedited basis with respect to perishable foods.

(3) Security of detained article.--An order under paragraph (1) with respect to an article of food

may require that such article be labeled or marked as detained, and shall require that the

article be removed to a secure facility, as appropriate. An article subject to such an order shall

not be transferred by any person from the place at which the article is ordered detained, or

from the place to which the article is so removed, as the case may be, until released by the

Secretary or until the expiration of the detention period applicable under such order, whichever

occurs first. This subsection may not be construed as authorizing the delivery of the article

pursuant to the execution of a bond while the article is subject to the order, and section 801(b)

does not authorize the delivery of the article pursuant to the execution of a bond while the

article is subject to the order.

(4) Appeal of detention order.--

(A) In general.--With respect to an article of food ordered detained under paragraph (1), any

person who would be entitled to be a claimant for such article if the article were seized under

subsection (a) may appeal the order to the Secretary. Within five days after such an appeal is

filed, the Secretary, after providing opportunity for an informal hearing, shall confirm or

terminate the order involved, and such confirmation by the Secretary shall be considered a

final agency action for purposes of section 702 of title 5, United States Code. If during such

five-day period the Secretary fails to provide such an opportunity, or to confirm or terminate

such order, the order is deemed to be terminated.

(B) Effect of instituting court action.— The process under subparagraph (A) for the appeal of

an order under paragraph (1) terminates if the Secretary institutes an action under subsection

(a) or section 302 regarding the article of food involved.

HEARING BEFORE REPORT OF CRIMINAL VIOLATION

SEC. 305. [21 U.S.C. 335] Before any violation of this Act is reported by the Secretary to any

United States attorney for institution of a criminal proceeding, the person against whom such

proceeding is contemplated shall be given appropriate notice and an opportunity to present his

views, either orally or in writing, with regard to such contemplated proceeding.

DEBARMENT, TEMPORARY DENIAL OF APPROVAL, AND SUSPENSION

SEC. 306. [ 21 U.S.C. 335a] (a) MANDATORY DEBARMENT; CERTAIN DRUG

APPLICATIONS. –

(1) CORPORATIONS, PARTNERSHIPS, AND ASSOCIATIONS. -- If the Secretary finds that

a person other than an individual has been convicted, after the date of enactment of this

section, of a felony under Federal law for conduct relating to the development or approval,

including the process for development or approval, of any abbreviated drug application, the

Secretary shall debar such person from submitting, or assisting in the submission of, any such

application.

(2) INDIVIDUALS. -- If the Secretary finds that an individual has been convicted of a felony

under Federal law for conduct –

(A) relating to the development or approval, including the process for development or approval,

of any drug product, or

(B) otherwise relating to the regulation of any drug product under this Act, the Secretary shall

debar such individual from providing services in any capacity to a person that has an approved

or pending drug product application.

(b) Permissive Debarment; Certain Drug Applications; Food Imports.—

(1) IN GENERAL. -- The Secretary, on the Secretary's own initiative or in response to a

petition, may, in accordance with paragraph (2), debar –

(A) a person other than an individual from submitting or assisting in the submission of any

abbreviated drug application, or

(B) an individual from providing services in any capacity to a person that has an approved or

pending drug product application . , or

(C) a person from importing an article of food or offering such an article for import into the

United States .

(2) PERSONS SUBJECT TO Permissive debarment; certain drug applications. -- The

following persons are subject to debarment under subparagraph (A) or (B) of paragraph (1):

(A) CORPORATIONS, PARTNERSHIPS, AND ASSOCIATIONS. -- Any person other than an

individual that the Secretary finds has been convicted –

(i) for conduct that –

(I) relates to the development or approval, including the process for the development or

approval, of any abbreviated drug application; and

(II) is a felony under Federal law (if the person was convicted before the date of enactment of

this section), a misdemeanor under Federal law, or a felony under State law, or

(ii) of a conspiracy to commit, or aiding or abetting, a criminal offense described in clause (i) or

a felony described in subsection (a)(1),

if the Secretary finds that the type of conduct which served as the basis for such conviction

undermines the process for the regulation of drugs.

(B) INDIVIDUALS. –

(i) Any individual whom the Secretary finds has been convicted of –

(I) a misdemeanor under Federal law or a felony under State law for conduct relating to the

development or approval, including the process for development or approval, of any drug

product or otherwise relating to the regulation of drug products under this Act, or

(II) a conspiracy to commit, or aiding or abetting, such criminal offense or a felony described in

subsection (a)(2),

if the Secretary finds that the type of conduct which served as the basis for such conviction

undermines the process for the regulation of drugs.

(ii) Any individual whom the Secretary finds has been convicted of –

(I) a felony which is not described in subsection (a)(2) or clause (i) of this subparagraph and

which involves bribery, payment of illegal gratuities, fraud, perjury, false statement,

racketeering, blackmail, extortion, falsification or destruction of records, or interference with,

obstruction of an investigation into, or prosecution of, any criminal offense, or

(II) a conspiracy to commit, or aiding or abetting, such felony,

If the Secretary finds, on the basis of the conviction of such individual and other information,

that such individual has demonstrated a pattern of conduct sufficient to find that there is

reason to believe that such individual may violate requirements under this Act relating to drug

products.

(iii) Any individual whom the Secretary finds materially participated in acts that were the basis

for a conviction for an offense described in subsection (a) or in clause (i) or (ii) for which a

conviction was obtained, if the Secretary finds, on the basis of such participation and other

information, that such individual has demonstrated a pattern of conduct sufficient to find that

there is reason to believe that such individual may violate requirements under this Act relating

to drug products.

(iv) Any high managerial agent whom the Secretary finds –

(I) worked for, or worked as a consultant for, the same person as another individual during the

period in which such other individual took actions for which a felony conviction was obtained

and which resulted in the debarment under subsection (a)(2), or clause (i), of such other

individual,

(II) had actual knowledge of the actions described in subclause (I) of such other individual, or

took action to avoid such actual knowledge, or failed to take action for the purpose of avoiding

such actual knowledge,

(III) knew that the actions described in subclause (I) were violative of law, and

(IV) did not report such actions, or did not cause such actions to be reported, to an officer,

employee, or agent of the Department or to an appropriate law enforcement officer, or failed to

take other appropriate action that would have ensured that the process for the regulation of

drugs was not undermined, within a reasonable time after such agent first knew of such

actions,

if the Secretary finds that the type of conduct which served as the basis for such other

individual's conviction undermines the process for the regulation of drugs.

(3) Persons subject to permissive debarment; food importation.--A person is subject to

debarment under paragraph (1)(C) if--

(A) the person has been convicted of a felony for conduct relating to the importation into the

United States of any food; or

(B) the person has engaged in a pattern of importing or offering for import adulterated food that

presents a threat of serious adverse health consequences or death to humans or animals.

(4) STAY OF CERTAIN ORDERS. An order of the Secretary under clause (iii) or (iv) of

paragraph (2)(B) shall not take effect until 30 days after the order has been issued.

(c) DEBARMENT PERIODS AND CONSIDERATIONS. --

(1) EFFECT OF DEBARMENT. -- The Secretary -

(A) shall not accept or review (other than in connection with an audit under this section) any

abbreviated drug application submitted by or with the assistance of a person debarred under

subsection (a)(1) or (b)(2)(A) during the period such person is debarred,

(B) shall, during the period of a debarment under subsection (a)(2) or (b)(2)(B), debar an

individual from providing services in any capacity to a person that has an approved or pending

drug product application and shall not accept or review (other than in connection with an audit

under this section) an abbreviated drug application from such individual, and

(C) shall, if the Secretary makes the finding described in paragraph (6) or (7) of section 307(a),

assess a civil penalty in accordance with section 307.

(2) DEBARMENT PERIODS. --

(A) IN GENERAL. -- The Secretary shall debar a person under subsection (a) or (b) for the

following periods:

(i) The period of debarment of a person (other than an individual) under subsection (a)(1) shall

not be less than 1 year or more than 10 years, but if an act leading to a subsequent debarment

under subsection (a) occurs within 10 years after such person has been debarred under

subsection (a)(1), the period of debarment shall be permanent.

(ii) The debarment of an individual under subsection (a)(2) shall be permanent.

(iii) The period of debarment of any person under paragraph (2) or (3) of subsection (b) shall

not be more than 5 years. The Secretary may determine whether debarment periods shall run

concurrently or consecutively in the case of a person debarred for multiple offenses.

(B) NOTIFICATION. -- Upon a conviction for an offense described in subsection (a) or (b) or

upon execution of an agreement with the United States to plead guilty to such an offense, the

person involved may notify the Secretary that the person acquiesces to debarment and such

person's debarment shall commence upon such notification.

(3) CONSIDERATIONS. -- In determining the appropriateness and the period of a debarment

of a person under subsection (b) and any period of debarment beyond the minimum specified

in subparagraph (A)(i) of paragraph (2), the Secretary shall consider where applicable -

(A) the nature and seriousness of any offense involved,

(B) the nature and extent of management participation in any offense involved, whether

corporate policies and practices encouraged the offense, including whether inadequate

institutional controls contributed to the offense,

(C) the nature and extent of voluntary steps to mitigate the impact on the public of any offense

involved, including the recall or the discontinuation of the distribution of suspect drugs, full

cooperation with any investigations (including the extent of disclosure to appropriate

authorities of all wrongdoing), the relinquishing of profits on drug approvals fraudulently

obtained, and any other actions taken to substantially limit potential or actual adverse effects

on the public health,

(D) whether the extent to which changes in ownership, management, or operations have

corrected the causes of any offense involved and provide reasonable assurances that the

offense will not occur in the future,

(E) whether the person to be debarred is able to present adequate evidence that current

production of drugs subject to abbreviated drug applications and all pending abbreviated drug

applications are free of fraud or material false statements, and

(F) prior convictions under this Act or under other Acts involving matters within the jurisdiction

of the Food and Drug Administration.

(d) TERMINATION OF DEBARMENT. --

(1) APPLICATION. -- Any person that is debarred under subsection (a) (other than a person

permanently debarred) or any person that is debarred under subsection (b) of this section may

apply to the Secretary for termination of the debarment under this subsection. Any information

submitted to the Secretary under this paragraph does not constitute an amendment or

supplement to pending or approved abbreviated drug applications.

(2) DEADLINE. -- The Secretary shall grant or deny any application respecting a debarment

which is submitted under paragraph (1) within 180 days of the date the application is

submitted.

(3) ACTION BY THE SECRETARY. –

(A) CORPORATIONS. --

(i) CONVICTION REVERSAL. -- If the conviction which served as the basis for the debarment

of a person under subsection (a)(1) (b) or paragraph (2)(A) or (3) of subsection is reversed, the

Secretary shall withdraw the order of debarment.

(ii) APPLICATION. -- Upon application submitted under paragraph (1), the Secretary shall

terminate the debarment of a person if the Secretary finds that –

(I) changes in ownership, management, or operations have fully corrected the causes of the

offense involved and provide reasonable assurances that the offense will not occur in the

future, and

(II) in applicable cases, sufficient audits, conducted by the Food and Drug Administration or by

independent experts acceptable to the Food and Drug Administration, demonstrate that

pending applications and the development of drugs being tested before the submission of an

application are free of fraud or material false statements.

In the case of persons debarred under subsection (a)(1), such termination shall take effect no

earlier than the expiration of one year from the date of the debarment.

(B) INDIVIDUALS. –

(i) CONVICTION REVERSAL. -- If the conviction which served as the basis for the debarment

of an individual under subsection (a)(2) or clause (i), (ii), (iii), or (iv) of subsection (b)(2)(B) or

subsection (b)(3) is reversed, the Secretary shall withdraw the order of debarment.

(ii) APPLICATION. -- Upon application submitted under paragraph (1), the Secretary shall

terminate the debarment of an individual who has been debarred under subsection (b)(2)(B) or

subsection (b)(3) if such termination serves the interests of justice and adequately protects the

integrity of the drug approval process or the food importation process, as the case may be.

(4) SPECIAL TERMINATION. –

(A) APPLICATION. -- Any person that is debarred under subsection (a)(1) (other than a person

permanently debarred under subsection (c)(2)(A)(i)) or any individual who is debarred under

subsection (a)(2) may apply to the Secretary for special termination of debarment under this

subsection. Any information submitted to the Secretary under this subparagraph does not

constitute an amendment or supplement to pending or approved abbreviated drug

applications.

(B) CORPORATIONS. -- Upon an application submitted under subparagraph (A), the

Secretary may take the action described in subparagraph (D) if the Secretary, after an informal

hearing, finds that –

(i) the person making the application under subparagraph (A) has demonstrated that the felony

conviction which was the basis for such person's debarment involved the commission of an

offense which was not authorized, requested, commanded, performed, or recklessly tolerated

by the board of directors or by a high managerial agent acting on behalf of the person within

the scope of the board's or agent's office or employment,

(ii) all individuals who were involved in the commission of the offense or who knew or should

have known of the offense have been removed from employment involving the development or

approval of any drug subject to sections 9 505,

(iii) the person fully cooperated with all investigations and promptly disclosed all wrongdoing to

the appropriate authorities, and

(iv) the person acted to mitigate any impact on the public of any offense involved, including the

recall, or the discontinuation of the distribution, of any drug with respect to which the Secretary

requested a recall or discontinuation of distribution due to concerns about the safety or efficacy

of the drug.

(C) INDIVIDUALS. -- Upon an application submitted under subparagraph (A), the Secretary

may take the action described in subparagraph (D) if the Secretary, after an informal hearing,

finds that such individual has provided substantial assistance in the investigations or

prosecutions of offenses which are described in subsection (a) or (b) or which relate to any

matter under the jurisdiction of the Food and Drug Administration.

(D) SECRETARIAL ACTION -- The action referred to in subparagraphs (B) and (C) is –

(i) in the case of a person other than an individual –

(I) terminating the debarment immediately, or

(II) limiting the period of debarment to less than one year, and

(ii) in the case of an individual, limiting the period of debarment to less than permanent but to

no less than 1 year, whichever best serves the interest of justice and protects the integrity of

the drug approval process.

(e) PUBLICATION AND LIST OF DEBARRED PERSONS. -- The Secretary shall publish in

the Federal Register the name of any person debarred under subsection (a) or (b), the

effective date of the debarment, and the period of the debarment. The Secretary shall also

maintain and make available to the public a list, updated no less often than quarterly, of such

persons, of the effective dates and minimum periods of such debarments, and of the

termination of debarments.

(f) TEMPORARY DENIAL OF APPROVAL. --

(1) IN GENERAL. -- The Secretary, on the Secretary's own initiative or in response to a

petition, may, in accordance with paragraph (3), refuse by order, for the period prescribed by

paragraph (2), to approve any abbreviated drug application submitted by any person –

(A) if such person is under an active Federal criminal investigation in connection with an action

described in subparagraph (B),

(B) if the Secretary finds that such person –

(i) has bribed or attempted to bribe, has paid or attempted to pay an illegal gratuity, or has

induced or attempted to induce another person to bribe or pay an illegal gratuity to any officer,

employee, or agent of the Department of Health and Human Services or to any other Federal,

State, or local official in connection with any abbreviated drug application, or has conspired to

commit, or aided or abetted, such actions, or

(ii) has knowingly made or caused to be made a pattern or practice of false statements or

misrepresentations with respect to material facts relating to any abbreviated drug application,

or the production of any drug subject to an abbreviated drug application, to any officer,

employee, or agent of the Department of Health and Human Services, or has conspired to

commit, or aided or abetted, such actions, and

(C) if a significant question has been raised regarding –

(i) the integrity of the approval process with respect to such abbreviated drug application, or

(ii) the reliability of data in or concerning such person's abbreviated drug application.

Such an order may be modified or terminated at any time.

(2) APPLICABLE PERIOD. --

(A) IN GENERAL. -- Except as provided in subparagraph (B), a denial of approval of an

application of a person under paragraph (1) shall be in effect for a period determined by the

Secretary but not to exceed 18 months beginning on the date the Secretary finds that the

conditions described in subparagraphs (A), (B), and (C) of paragraph (1) exist. The Secretary

shall terminate such denial -

(i) if the investigation with respect to which the finding was made does not result in a criminal

charge against such person, if criminal charges have been brought and the charges have been

dismissed, or if a judgment of acquittal has been entered, or

(ii) if the Secretary determines that such finding was in error.

(B) EXTENSION. -- If, at the end of the period described in subparagraph (A), the Secretary

determines that a person has been criminally charged for an action described in subparagraph

(B) of paragraph (1), the Secretary may extend the period of denial of approval of an

application for a period not to exceed 18 months. The Secretary shall terminate such extension

if the charges have been dismissed, if a judgment of acquittal has been entered, or if the

Secretary determines that the finding described in subparagraph (A) was in error.

(3) INFORMAL HEARING. -- Within 10 days of the date an order is issued under paragraph (1),

the Secretary shall provide such person with an opportunity for an informal hearing, to be held

within such 10 days, on the decision of the Secretary to refuse approval of an abbreviated drug

application. Within 60 days of the date on which such hearing is held, the Secretary shall notify

the person given such hearing whether the Secretary's refusal of approval will be continued,

terminated, or otherwise modified. Such notification shall be final agency action.

(g) SUSPENSION AUTHORITY. --

(1) IN GENERAL. -- If -

(A) the Secretary finds -

(i) that a person has engaged in conduct described in subparagraph (B) of subsection (f)(1) in

connection with 2 or more drugs under abbreviated drug applications, or

(ii) that a person has engaged in flagrant and repeated, material violations of good

manufacturing practice or good laboratory practice in connection with the development,

manufacturing, or distribution of one or more drugs approved under an abbreviated drug

application during a 2-year period, and -

(I) such violations may undermine the safety and efficacy of such drugs, and

(II) the causes of such violations have not been corrected within a reasonable period of time

following notice of such violations by the Secretary, and

(B) such person is under an active investigation by a Federal authority in connection with a civil

or criminal action involving conduct described in subparagraph (A), the Secretary shall issue

an order suspending the distribution of all drugs the development or approval of which was

related to such conduct described in subparagraph (A) or suspending the distribution of all

drugs approved under abbreviated drug applications of such person if the Secretary finds that

such conduct may have affected the development or approval of a significant number of drugs

which the Secretary is unable to identify. The Secretary shall exclude a drug from such order if

the Secretary determines that such conduct was not likely to have influenced the safety or

efficacy of such drug.

(2) PUBLIC HEALTH WAIVER. -- The Secretary shall, on the Secretary's own initiative or in

response to a petition, waive the suspension under paragraph (1) (involving an action

described in paragraph (1)(A)(i)) with respect to any drug if the Secretary finds that such

waiver is necessary to protect the public health because sufficient quantities of the drug would

not otherwise be available. The Secretary shall act on any petition seeking action under this

paragraph within 180 days of the date the petition is submitted to the Secretary.

(h) TERMINATION OF SUSPENSION. -- The Secretary shall withdraw an order of suspension

of the distribution of a drug under subsection (g) if the person with respect to whom the order

was issued demonstrates in a petition to the Secretary -

(1)(A) on the basis of an audit by the Food and Drug Administration or by experts acceptable

to the Food and Drug Administration, or on the basis of other information, that the

development, approval, manufacturing, and distribution of such drug is in substantial

compliance with the applicable requirements of this Act, and

(B) changes in ownership, management, or operations –

(i) fully remedy the patterns or practices with respect to which the order was issued, and

(ii) provide reasonable assurances that such actions will not occur in the future, or

(2) the initial determination was in error.

The Secretary shall act on a submission of a petition under this subsection within 180 days of

the date of its submission and the Secretary may consider the petition concurrently with the

suspension proceeding. Any information submitted to the Secretary under this subsection

does not constitute an amendment or supplement to a pending or approved abbreviated drug

application.

(i) PROCEDURE. -- The Secretary may not take any action under subsection (a), (b), (c),

(d)(3), (g), or (h) with respect to any person unless the Secretary has issued an order for such

action made on the record after opportunity for an agency hearing on disputed issues of

material fact. In the course of any investigation or hearing under this subsection, the Secretary

may administer oaths and affirmations, examine witnesses, receive evidence, and issue

subpoenas requiring the attendance and testimony of witnesses and the production of

evidence that relates to the matter under investigation.

(j) JUDICAL REVIEW

(1) IN GENERAL. -- Except as provided in paragraph (2), any person that is the subject of an

adverse decision under subsection (a), (b), (c), (d), (f), (g), or (h) may obtain a review of such

decision by the United States Court of Appeals for the District of Columbia or for the circuit in

which the person resides, by filing in such court (within 60 days following the date the person is

notified of the Secretary's decision) a petition requesting that the decision be modified or set

aside.

(2) EXCEPTION. -- Any person that is the subject of an adverse decision under clause (iii) or

(iv) of subsection (b)(2)(B) may obtain a review of such decision by the United States District

Court for the District of Columbia or a district court of the United States for the district in which

the person resides, by filing in such court (within 30 days following the date the person is

notified of the Secretary's decision) a complaint requesting that the decision be modified or set

aside. In such an action, the court shall determine the matter de novo.

(k) CERTIFICATION. -- Any application for approval of a drug product shall include -

(1) a certification that the applicant did not and will not use in any capacity the services of any

person debarred under subsection (a) or (b), in connection with such application, and

(2) if such application is an abbreviated drug application, a list of all convictions, described in

subsections (a) and (b) which occurred within the previous 5 years, of the applicant and

affiliated persons responsible for the development or submission of such application.

(l) APPLICABILITY. --

(1) CONVICTION. -- For purposes of this section, a person is considered to have been

convicted of a criminal offense -

(A) when a judgment of conviction has been entered against the person by a Federal or State

court, regardless of whether there is an appeal pending,

(B) when a plea of guilty or nolo contendere by the person has been accepted by a Federal or

State court, or

(C) when the person has entered into participation in a first offender, deferred adjudication, or

other similar arrangement or program where judgment of conviction has been withheld.

(2) EFFECTIVE DATES. -- Subsection (a), subparagraph (A) of subsection (b)(2), and

subsection (b)(3)(A) clauses (i) and (ii) of subsection (b)(2)(B) shall not apply to a conviction

which occurred more than 5 years before the initiation of an agency action proposed to be

taken under subsection (a) or (b). Clauses (iii) and (iv) of subsection (b)(2)(B) , subsection

(b)(3)(B) and subsections (f) and (g) shall not apply to an act or action which occurred more

than 5 years before the initiation of an agency action proposed to be taken under subsection

(b), (f), or (g). Clause (iv) of subsection (b)(2)(B) shall not apply to an action which occurred

before June 1, 1992 . Subsection (k) shall not apply to applications submitted to the Secretary

before June 1, 1992 .

(m) Devices; Mandatory Debarment Regarding Third-Party Inspections and Reviews.--

(1) In general.--If the Secretary finds that a person has been convicted of a felony under

section 301( gg), the Secretary shall debar such person from being accredited under section

523(b) or 704(g)(2) and from carrying out activities under an agreement described in section

803(b).

(2) Debarment period.--The Secretary shall debar a person under paragraph (1) for the

following periods:

(A) The period of debarment of a person (other than an individual) shall not be less than 1 year

or more than 10 years, but if an act leading to a subsequent debarment under such paragraph

occurs within 10 years after such person has been debarred under such paragraph, the period

of debarment shall be permanent.

(B) The debarment of an individual shall be permanent.

(3) Termination of debarment; judicial review; other matters.--Subsections (c)(3), (d), (e), (i), (j),

and (l)(1) apply with respect to a person (other than an individual) or an individual who is

debarred under paragraph (1) to the same extent and in the same manner as such

subsections apply with respect to a person who is debarred under subsection (a)(1), or an

individual who is debarred under subsection (a)(2), respectively.

CIVIL PENALTIES

SEC. 307. [21 U.S.C. 335b] (a) IN GENERAL.—Any person that the Secretary finds—

(1) knowingly made or caused to be made, to any officer, employee, or agent of the

Department of Health and Human Services, a false statement or misrepresentation of a

material fact in connection with an abbreviated drug application,

(2) bribed or attempted to bribe or paid or attempted to pay an illegal gratuity to any officer,

employee, or agent of the Department of Health and Human Services in connection with an

abbreviated drug application,

(3) destroyed, altered, removed, or secreted, or procured the destruction, alteration, removal,

or secretion of, any material document or other material evidence which was the property of or

in the possession of the Department of Health and Human Services for the purpose of

interfering with that Department’s discharge of its responsibilities in connection with an

abbreviated drug application,

(4) knowingly failed to disclose, to an officer or employee of the Department of Health and

Human Services, a material fact which such person had an obligation to disclose relating to

any drug subject to an abbreviated drug application,

(5) knowingly obstructed an investigation of the Department of Health and Human Services

into any drug subject to an abbreviated drug application,

(6) is a person that has an approved or pending drug product application and has knowingly—

(A) employed or retained as a consultant or contractor, or

(B) otherwise used in any capacity the services of, a person who was debarred under section

306, or

(7) is an individual debarred under section 306 and, during the period of debarment, provided

services in any capacity to a person that had an approved or pending drug product application,

shall be liable to the United States for a civil penalty for each such violation in an amount not to

exceed $250,000 in the case of an individual and $1,000,000 in the case of any other person.

(b) PROCEDURE.—

(1) IN GENERAL.—

(A) ACTION BY THE SECRETARY.—A civil penalty under subsection (a) shall be assessed

by the Secretary on a person by an order made on the record after an opportunity for an

agency hearing on disputed issues of material fact and the amount of the penalty. In the

course of any investigation or hearing under this subparagraph, the Secretary may administer

oaths and affirmations, examine witnesses, receive evidence, and issue subpoenas requiring

the attendance and testimony of witnesses and the production of evidence that relates to the

matter under investigation.

(B) ACTION BY THE ATTORNEY GENERAL.—In lieu of a proceeding under subparagraph

(A), the Attorney General may, upon request of the Secretary, institute a civil action to recover

a civil money penalty in the amount and for any of the acts set forth in subsection (a). Such an

action may be instituted separately from or in connection with any other claim, civil or criminal,

initiated by the Attorney General under this Act.

(2) AMOUNT.—In determining the amount of a civil penalty under paragraph (1), the Secretary

or the court shall take into account the nature, circumstances, extent, and gravity of the act

subject to penalty, the person’s ability to pay, the effect on the person’s ability to continue to do

business, any history of prior, similar acts, and such other matters as justice may require.

(3) LIMITATION ON ACTIONS.—No action may be initiated under this section—

(A) with respect to any act described in subsection (a) that occurred before the date of the

enactment of this section, or

(B) more than 6 years after the date when facts material to the act are known or reasonably

should have been known by the Secretary but in no event more than 10 years after the date

the act took place.

(c) JUDICIAL REVIEW.—Any person that is the subject of an adverse decision under

subsection (b)(1)(A) may obtain a review of such decision by the United States Court of

Appeals for the District of Columbia or for the circuit in which the person resides, by filing in

such court (within 60 days following the date the person is notified of the Secretary’s decision)

a petition requesting that the decision be modified or set aside.

(d) RECOVERY OF PENALTIES.—The Attorney General may recover any civil penalty (plus

interest at the currently prevailing rates from the date the penalty became final) assessed

under subsection (b)(1)(A) in an action brought in the name of the United States . The amount

of such penalty may be deducted, when the penalty has become final, from any sums then or

later owing by the United States to the person against whom the penalty has been assessed.

In an action brought under this subsection, the validity, amount, and appropriateness of the

penalty shall not be subject to judicial review.

(e) INFORMANTS.—The Secretary may award to any individual (other than an officer or

employee of the Federal Government or a person who materially participated in any conduct

described in subsection (a)) who provides information leading to the imposition of a civil

penalty under this section an amount not to exceed—

(1) $250,000, or

(2) one-half of the penalty so imposed and collected, whichever is less. The decision of the

Secretary on such award shall not be reviewable.

AUTHORITY TO WITHDRAW APPROVAL OF ABBREVIATED DRUG APPLICATIONS

SEC. 308. [21 U.S.C. 335c] (a) IN GENERAL.—The Secretary—

(1) shall withdraw approval of an abbreviated drug application if the Secretary finds that the

approval was obtained, expedited, or otherwise facilitated through bribery, payment of an

illegal gratuity, or fraud or material false statement, and

(2) may withdraw approval of an abbreviated drug application if the Secretary finds that the

applicant has repeatedly demonstrated a lack of ability to produce the drug for which the

application was submitted in accordance with the formulations or manufacturing practice set

forth in the abbreviated drug application and has introduced, or attempted to introduce, such

adulterated or misbranded drug into commerce.

(b) PROCEDURE.—The Secretary may not take any action under subsection (a) with respect

to any person unless the Secretary has issued an order for such action made on the record

after opportunity for an agency hearing on disputed issues of material fact. In the course of any

investigation or hearing under this subsection, the Secretary may administer oaths and

affirmations, examine witnesses, receive evidence, and issue subpoenas requiring the

attendance and testimony of witnesses and the production of evidence that relates to the

matter under investigation.

(c) APPLICABILITY.—Subsection (a) shall apply with respect to offenses or acts regardless of

when such offenses or acts occurred.

(d) JUDICIAL REVIEW.—Any person that is the subject of an adverse decision under

subsection (a) may obtain a review of such decision by the United States Court of Appeals for

the District of Columbia or for the circuit in which the person resides, by filing in such court

(within 60 days following the date the person is notified of the Secretary’s decision) a petition

requesting that the decision be modified or set aside.

REPORT OF MINOR VIOLATIONS

SEC. 309. [21 U.S.C. 336] Nothing in this Act shall be construed as requiring the Secretary to

report for prosecution, or for the institution of libel or injunction proceedings, minor violations of

this Act whenever he believes that the public interest will be adequately served by a suitable

written notice or warning.

PROCEEDINGS IN NAME OF UNITED STATES; PROVISION AS TO SUBPOENAS

SEC. 310. [21 U.S.C. 337] (a) Except as provided in subsection (b), all such proceedings for

the enforcement, or to restrain violations, of this Act shall be by and in the name of the United

States . Subpoenas for witnesses who are required to attend a court of the United States , in

any district, may run into any other district in any proceeding under this section.

(b)(1) A State may bring in its own name and within its jurisdiction proceedings for the civil

enforcement, or to restrain violations, of section 401, 403(b), 403(c), 403(d), 403(e), 403(f),

403(g), 403(h), 403(i), 403(k), 403(q), or 403(r) if the food that is the subject of the proceedings

is located in the State.

(2) No proceeding may be commenced by a State under paragraph (1)—

(A) before 30 days after the State has given notice to the Secretary that the State intends to

bring such proceeding,

(B) before 90 days after the State has given notice to the Secretary of such intent if the

Secretary has, within such 30 days, commenced an informal or formal enforcement action

pertaining to the food which would be the subject of such proceeding, or

(C) if the Secretary is diligently prosecuting a proceeding in court pertaining to such food, has

settled such proceeding, or has settled the informal or formal enforcement action pertaining to

such food.

In any court proceeding described in subparagraph (C), a State may intervene as a matter of

right.

Footnotes: Chapter III

1. See footnote for section 403(h)(3) regarding the stylistic use of a list consisting of "(a)",

"(b)", etc.

2. The period is so in law. See section 102(b)(5)(C) of Public Law 108-282

3. The period is so in law. See section 102f(b)(5)(D) of Public Law 108-282.

4. So in law. See the amendment made by section 403 of Public Law 104–170 (110 Stat.

1514).

5. Paragraph (l) was struck by section 421 of Public Law 105–115 (111 Stat. 2380).

6. Paragraph (z) was added by subsection (b) of section 401(b) of Public Law 105–115 (111

Stat. 2364). Subsection (e) of such section provides as follows:

(e) SUNSET.—The amendments made by this section cease to be effective September 30,

2006, or 7 years after the date on which the Secretary promulgates the regulations described

in subsection (c), whichever is later.

7. So in law. Probably should be followed by a comma.

8. 1 The subsection is designated as subsection (f) to be consistent with the United States

Code. Prior to the enactment of Public Law 103–322, the last three subsections in section 303

were a subsection (e) that related to anabolic steroids, a subsection (f) that related to human

growth hormone, and a subsection (g) that related to civil penalties. Section 330015 of Public

Law 103-322 (108 Stat. 2146) amended the amendatory instructions of section 1904 of Public

Law 101– 647 with the result that the subsection (e) relating to anabolic steroids was struck,

and the subsection (f) relating to human growth hormone was redesignated as subsection (e).

Section 330015 did not, as a conforming amendment, expressly redesignate the subsection (g)

on civil penalties as subsection (f). The United States Code, however, shows the subsection

on civil penalties as subsection (f), and that approach is taken above to be consistent with the

Code.

9. So in law. See section 125(b)(2)(C) of Public Law 105-115 (111 Stat. 2325). Probably

should be "section".

CHAPTER IV—FOOD

DEFINITIONS AND STANDARDS FOR FOOD

SEC. 401. [21 U.S.C. 341] Whenever in the judgment of the Secretary such action will promote

honesty and fair dealing in the interest of consumers, he shall promulgate regulations fixing

and establishing for any food, under its common or usual name so far as practicable, a

reasonable definition and standard of identity, a reasonable standard of quality, or reasonable

standards of fill of container. No definition and standard of identity and no standard of quality

shall be established for fresh or dried fruits, fresh or dried vegetables, or butter, except that

definitions and standards of identity may be established for avocados, cantaloupes, citrus

fruits, and melons. In prescribing any standard of fill of container, the Secretary shall give due

consideration to the natural shrinkage in storage and in transit of fresh natural food and to

need for the necessary packing and protective material. In the prescribing of any standard of

quality for any canned fruit or canned vegetable, consideration shall be given and due

allowance made for the differing characteristics of the several varieties of such fruit or

vegetable. In prescribing a definition and standard of identity for any food or class of food in

which optional ingredients are permitted, the Secretary shall, for the purpose of promoting

honesty and fair dealing in the interest of consumers, designate the optional ingredients which

shall be named on the label. Any definition and standard of identity prescribed by the

Secretary for avocados, cantaloupes, citrus fruits, or melons shall relate only to maturity and to

the effects of freezing.

ADULTERATED FOOD

SEC. 402. [21 U.S.C. 342] A food shall be deemed to be adulterated— 1

(a) Poisonous, insanitary, or deleterious ingredients.

(1) If it bears or contains any poisonous or deleterious substance which may render it injurious

to health; but in case the substance is not an added substance such food shall not be

considered adulterated under this clause if the quantity of such substance in such food does

not ordinarily render it injurious to health; [or] 2 (2)(A) 3 if it bears or contains any added

poisonous or added deleterious substance (other than a substance that is a pesticide chemical

residue in or on a raw agricultural commodity or processed food, a food additive, a color

additive, or a new animal drug) that is unsafe within the meaning of section 406; or (B) if it

bears or contains a pesticide chemical residue that is unsafe within the meaning of section

408(a); or (C) if it is or if it bears or contains (i) any food additive that is unsafe within the

meaning of section 409; or (ii) a new animal drug (or conversion product thereof) that is unsafe

within the meaning of section 512; or (3) if it consists in whole or in part of any filthy, putrid, or

decomposed substance, or if it is otherwise unfit for food; or (4) if it has been prepared, packed,

or held under insanitary conditions whereby it may have become contaminated with filth, or

whereby it may have been rendered injurious to health; or (5) if it is, in whole or in part, the

product of a diseased animal or of an animal which has died otherwise than by slaughter; or (6)

if its container is composed, in whole or in part, of any poisonous or deleterious substance

which may render the contents injurious to health; or (7) if it has been intentionally subjected to

radiation, unless the use of the radiation was in conformity with a regulation or exemption in

effect pursuant to section 409.

(b) Absence, substitution, or addition of constituents.

(1) If any valuable constituent has been in whole or in part omitted or abstracted therefrom; or

(2) if any substance has been substituted wholly or in part therefore; or (3) if damage or

inferiority has been concealed in any manner; or (4) if any substance has been added thereto

or mixed or packed therewith so as to increase its bulk or weight, or reduce its quality or

strength, or make it appear better or of greater value than it is.

(c) Color additives. If it is, or it bears or contains, a color additive which is unsafe within the

meaning of section 721(a).

(d) Confectionery containing alcohol or nonnutritive substance. If it is confectionery, and—

(1) has partially or completely imbedded therein any nonnutritive object, except that this

subparagraph shall not apply in the case of any nonnutritive object if, in the judgment of the

Secretary as provided by regulations, such object is of practical functional value to the

confectionery product and would not render the product injurious or hazardous to health;

(2) bears or contains any alcohol other than alcohol not in excess of one-half of 1 per centum

by volume derived solely from the use of flavoring extracts, except that this clause shall not

apply to confectionery which is introduced or delivered for introduction into, or received or held

for sale in, interstate commerce if the sale of such confectionery is permitted under the laws of

the State in which such confectionery is intended to be offered for sale; or

(3) bears or contains any nonnutritive substance, except that this subparagraph shall not apply

to a safe nonnutritive substance which is in or on confectionery by reason of its use for some

practical functional purpose in the manufacture, packaging, or storage of such confectionery if

the use of the substance does not promote deception of the consumer or otherwise result in

adulteration or misbranding in violation of any provision of this Act, except that the Secretary

may, for the purpose of avoiding or resolving uncertainty as to the application of this

subparagraph, issue regulations allowing or prohibiting the use of particular nonnutritive

substances.

(e) Oleomargarine containing filthy, putrid, etc., matter. If it is oleomargarine or margarine or

butter and any of the raw material used therein consisted in whole or in part of any filthy, putrid,

or decomposed substance, or such oleomargarine or margarine or butter is otherwise unfit for

food.

(f) Dietary supplement or ingredient: safety.

(1) If it is a dietary supplement or contains a dietary ingredient that—

(A) presents a significant or unreasonable risk of illness or injury under—

(i) conditions of use recommended or suggested in labeling, or

(ii) if no conditions of use are suggested or recommended in the labeling, under ordinary

conditions of use;

(B) is a new dietary ingredient for which there is inadequate information to provide reasonable

assurance that such ingredient does not present a significant or unreasonable risk of illness or

injury;

(C) the Secretary declares to pose an imminent hazard to public health or safety, except that

the authority to make such declaration shall not be delegated and the Secretary shall promptly

after such a declaration initiate a proceeding in accordance with sections 554 and 556 of title 5,

United States Code, to affirm or withdraw the declaration; or

(D) is or contains a dietary ingredient that renders it adulterated under paragraph (a)(1) under

the conditions of use recommended or suggested in the labeling of such dietary supplement.

In any proceeding under this subparagraph, the United States shall bear the burden of proof

on each element to show that a dietary supplement is adulterated. The court shall decide any

issue under this paragraph on a de novo basis.

(2) Before the Secretary may report to a United States attorney a violation of paragraph 4 (1)(A)

for a civil proceeding, the person against whom such proceeding would be initiated shall be

given appropriate notice and the opportunity to present views, orally and in writing, at least 10

days before such notice, with regard to such proceeding.

(g) Dietary supplement: manufacturing practices.

(1) If it is a dietary supplement and it has been prepared, packed, or held under conditions that

do not meet current good manufacturing practice regulations, including regulations requiring,

when necessary, expiration date labeling, issued by the Secretary under subparagraph (2).

(2) The Secretary may by regulation prescribe good manufacturing practices for dietary

supplements. Such regulations shall be modeled after current good manufacturing practice

regulations for food and may not impose standards for which there is no current and generally

available analytical methodology. No standard of current good manufacturing practice may be

imposed unless such standard is included in a regulation promulgated after notice and

opportunity for comment in accordance with chapter 5 of title 5, United States Code.

(h) Reoffer of food previously denied admission. If it is an article of food imported or offered for

import into the United States and the article of food has previously been refused admission

under section 801(a), unless the person reoffering the article affirmatively establishes, at the

expense of the owner or consignee of the article, that the article complies with the applicable

requirements of this Act, as determined by the Secretary.

(i) Unsanitary transport. If it is transported or offered for transport by a shipper, carrier by motor

vehicle or rail vehicle, receiver, or any other person engaged in the transportation of food

under conditions that are not in compliance with regulations promulgated under section 416.

MISBRANDED FOOD

SEC. 403. [21 U.S.C. 343] A food shall be deemed to be misbranded— 5

(a) False or misleading label. If (1) its labeling is false or misleading in any particular, or (2) in

the case of a food to which section 411 applies, its advertising is false or misleading in a

material respect or its labeling is in violation of section 411(b)(2).

(b) Offer for sale under another name. If it is offered for sale under the name of another food.

(c) Imitation of another food. If it is an imitation of another food, unless its label bears, in type of

uniform size and prominence, the word "imitation" and, immediately thereafter, the name of the

food imitated.

(d) Misleading container. If its container is so made, formed, or filled as to be misleading.

(e) Package form. If in package form unless it bears a label containing (1) the name and place

of business of the manufacturer, packer, or distributor; and (2) an accurate statement of the

quantity of the contents in terms of weight, measure, or numerical count, except that under

clause (2) of this paragraph reasonable variations shall be permitted, and exemptions as to

small packages shall be established, by regulations prescribed by the Secretary.

(f) Prominence of information on label. If any word, statement, or other information required by

or under authority of this Act to appear on the label or labeling is not prominently placed

thereon with such conspicuousness (as compared with other words, statements, designs, or

devices, in the labeling) and in such terms as to render it likely to be read and understood by

the ordinary individual under customary conditions of purchase and use.

(g) Representation as to definition and standard of identity. If it purports to be or is represented

as a food for which a definition and standard of identity has been prescribed by regulations as

provided by section 401, unless (1) it conforms to such definition and standard, and (2) its label

bears the name of the food specified in the definition and standard, and, insofar as may be

required by such regulations, the common names of optional ingredients (other than spices,

flavoring, and coloring) present in such food.

(h) Representation as to standards of quality and fill of container. If it purports to be or is

represented as—

(1) a food for which a standard of quality has been prescribed by regulations as provided by

section 401, and its quality falls below such standard, unless its label bears, in such manner

and form as such regulations specify, a statement that it falls below such standard; or

(2) a food for which a standard or standards of fill of container have been prescribed by

regulations as provided by section 401, and it falls below the standard of fill of container

applicable thereto, unless its label bears, in such manner and form as such regulations specify,

a statement that it falls below such standard; or

(3) a food that is pasteurized unless—

(A) such food has been subjected to a safe process or treatment that is prescribed as

pasteurization for such food in a regulation promulgated under this Act; or

(B)(i) such food has been subjected to a safe process or treatment that—

(I) is reasonably certain to achieve destruction or elimination in the food of the most resistant

microorganisms of public health significance that are likely to occur in the food;

(II) is at least as protective of the public health as a process or treatment described in

subparagraph (A);

(III) is effective for a period that is at least as long as the shelf life of the food when stored

under normal and moderate abuse conditions; and

(IV) is the subject of a notification to the Secretary, including effectiveness data regarding the

process or treatment; and

(ii) at least 120 days have passed after the date of receipt of such notification by the Secretary

without the Secretary making a determination that the process or treatment involved has not

been shown to meet the requirements of subclauses (I) through (III) of clause (i) 6.

For purposes of paragraph (3) 6, a determination by the Secretary that a process or treatment

has not been shown to meet the requirements of subclauses (I) through (III) of subparagraph

(B)(i) 6 shall constitute final agency action under such subclauses.

(i) Label where no representation as to definition and standard of quality. Unless its label bears

(1) the common or usual name of the food, if any there be, and (2) in case it is fabricated from

two or more ingredients, the common or usual name of each such ingredient and if the food

purports to be a beverage containing vegetable or fruit juice, a statement with appropriate

prominence on the information panel of the total percentage of such fruit or vegetable juice

contained in the food; except that spices, flavorings, and colors not required to be certified

under section 721(c) 7 unless sold as spices, flavorings, or such colors, may be designated as

spices, flavorings, and colorings without naming each. To the extent that compliance with the

requirements of clause (2) of this paragraph is impracticable, or results in deception or unfair

competition, exemptions shall be established by regulations promulgated by the Secretary.

(j) Representation for special dietary use. If it purports to be or is represented for special

dietary uses, unless its label bears such information concerning its vitamin, mineral, and other

dietary properties as the Secretary determines to be, and by regulations prescribes as,

necessary in order fully to inform purchasers as to its value for such uses.

(k) Artificial flavoring, artificial coloring, or chemical preservatives. If it bears or contains any

artificial flavoring, artificial coloring, or chemical preservative, unless it bears labeling stating

that fact, except that to the extent that compliance with the requirements of this paragraph is

impracticable, exemptions shall be established by regulations promulgated by the Secretary.

The provisions of this paragraph and paragraphs (g) and (i) with respect to artificial coloring

shall not apply in the case of butter, cheese, or ice cream. The provisions of this paragraph

with respect to chemical preservatives shall not apply to a pesticide chemical when used in or

on a raw agricultural commodity which is the produce of the soil.

(l) Pesticide chemicals on raw agricultural commodities. If it is a raw agricultural commodity

which is the produce of the soil, bearing or containing a pesticide chemical applied after

harvest, unless the shipping container of such commodity bears labeling which declares the

presence of such chemical in or on such commodity and the common or usual name and the

function of such chemical, except that no such declaration shall be required while such

commodity, having been removed from the shipping container, is being held or displayed for

sale at retail out of such container in accordance with the custom of the trade.

(m) Color additives. If it is a color additive, unless its packaging and labeling are in conformity

with such packaging and labeling requirements, applicable to such color additive, as may be

contained in regulations issued under section 721.

(n) If its packaging or labeling is in violation of an applicable regulation issued pursuant to

section 3 or 4 of the Poison Prevention Packaging Act of 1970.

(o) [Repealed] 8

(p) [Deleted] 8

(q) Nutrition information.

(1) Except as provided in subparagraphs (3), (4), and (5), if it is a food intended for human

consumption and is offered for sale, unless its label or labeling bears nutrition information that

provides—

(A)(i) the serving size which is an amount customarily consumed and which is expressed in a

common household measure that is appropriate to the food, or (ii) if the use of the food is not

typically expressed in a serving size, the common household unit of measure that expresses

the serving size of the food,

(B) the number of servings or other units of measure per container,

(C) the total number of calories—

(i) derived from any source, and

(ii) derived from the total fat,

in each serving size or other unit of measure of the food,

(D) the amount of the following nutrients: Total fat, saturated fat, cholesterol, sodium, total

carbohydrates, complex carbohydrates, sugars, dietary fiber, and total protein contained in

each serving size or other unit of measure,

(E) any vitamin, mineral, or other nutrient required to be placed on the label and labeling of

food under this Act before October 1, 1990 , if the Secretary determines that such information

will assist consumers in maintaining healthy dietary practices.

The Secretary may by regulation require any information required to be placed on the label or

labeling by this subparagraph or subparagraph (2)(A) to be highlighted on the label or labeling

by larger type, bold type, or contrasting color if the Secretary determines that such highlighting

will assist consumers in maintaining healthy dietary practices.

(2)(A) If the Secretary determines that a nutrient other than a nutrient required by

subparagraph (1)(C), (1)(D), or (1)(E) should be included in the label or labeling of food subject

to subparagraph (1) for purposes of providing information regarding the nutritional value of

such food that will assist consumers in maintaining healthy dietary practices, the Secretary

may by regulation require that information relating to such additional nutrient be included in the

label or labeling of such food.

(B) If the Secretary determines that the information relating to a nutrient required by

subparagraph (1)(C), (1)(D), or (1)(E) or clause (A) of this subparagraph to be included in the

label or labeling of food is not necessary to assist consumers in maintaining healthy dietary

practices, the Secretary may by regulation remove information relating to such nutrient from

such requirement.

(3) For food that is received in bulk containers at a retail establishment, the Secretary may, by

regulation, provide that the nutrition information required by subparagraphs (1) and (2) be

displayed at the location in the retail establishment at which the food is offered for sale.

(4)(A) The Secretary shall provide for furnishing the nutrition information required by

subparagraphs (1) and (2) with respect to raw agricultural commodities and raw fish by issuing

voluntary nutrition guidelines, as provided by clause (B) or by issuing regulations that are

mandatory as provided by clause (D).

(B)(i) Upon the expiration of 12 months after the date of the enactment of the Nutrition Labeling

and Education Act of 1990 [enacted Nov. 8, 1990]9 , the Secretary, after providing an

opportunity for comment, shall issue guidelines for food retailers offering raw agricultural

commodities or raw fish to provide nutrition information specified in subparagraphs (1) and (2).

Such guidelines shall take into account the actions taken by food retailers during such

12-month period to provide to consumers nutrition information on raw agricultural commodities

and raw fish. Such guidelines shall only apply—

(I) in the case of raw agricultural commodities, to the 20 varieties of vegetables most frequently

consumed during a year and the 20 varieties of fruit most frequently consumed during a year,

and

(II) to the 20 varieties of raw fish most frequently consumed during a year.

The vegetables, fruits, and raw fish to which such guidelines apply shall be determined by the

Secretary by regulation and the Secretary may apply such guidelines regionally.

(ii) Upon the expiration of 12 months after the date of the enactment of the Nutrition Labeling

and Education Act of 1990 [enacted Nov. 8, 1990] 9, the Secretary shall issue a final regulation

defining the circumstances that constitute substantial compliance by food retailers with the

guidelines issued under subclause (i). The regulation shall provide that there is not substantial

compliance if a significant number of retailers have failed to comply with the guidelines. The

size of the retailers and the portion of the market served by retailers in compliance with the

guidelines shall be considered in determining whether the substantial-compliance standard

has been met.

(C)(i) Upon the expiration of 30 months after the date of the enactment of the Nutrition

Labeling and Education Act of 1990 [enacted Nov. 8, 1990] 9 , the Secretary shall issue a

report on actions taken by food retailers to provide consumers with nutrition information for raw

agricultural commodities and raw fish under the guidelines issued under clause (A). Such

report shall include a determination of whether there is substantial compliance with the

guidelines.

(ii) If the Secretary finds that there is substantial compliance with the guidelines, the Secretary

shall issue a report and make a determination of the type required in subclause (i) every two

years.

(D)(i) If the Secretary determines that there is not substantial compliance with the guidelines

issued under clause (A), the Secretary shall at the time such determination is made issue

proposed regulations requiring that any person who offers raw agricultural commodities or raw

fish to consumers provide, in a manner prescribed by regulations, the nutrition information

required by subparagraphs (1) and (2). The Secretary shall issue final regulations imposing

such requirements 6 months after issuing the proposed regulations. The final regulations shall

become effective 6 months after the date of their promulgation.

(ii) Regulations issued under subclause (i) may require that the nutrition information required

by subparagraphs (1) and (2) be provided for more than 20 varieties of vegetables, 20

varieties of fruit, and 20 varieties of fish most frequently consumed during a year if the

Secretary finds that a larger number of such products are frequently consumed. Such

regulations shall permit such information to be provided in a single location in each area in

which raw agricultural commodities and raw fish are offered for sale. Such regulations may

provide that information shall be expressed as an average or range per serving of the same

type of raw agricultural commodity or raw fish. The Secretary shall develop and make available

to the persons who offer such food to consumers the information required by subparagraphs (1)

and (2).

(iii) Regulations issued under subclause (i) shall permit the required information to be provided

in each area of an establishment in which raw agricultural commodities and raw fish are

offered for sale. The regulations shall permit food retailers to display the required information

by supplying copies of the information provided by the Secretary, by making the information

available in brochure, notebook or leaflet form, or by posting a sign disclosing the information.

Such regulations shall also permit presentation of the required information to be supplemented

by a video, live demonstration, or other media which the Secretary approves.

(E) For purposes of this subparagraph, the term "fish" includes freshwater or marine fin fish,

crustaceans, and mollusks, including shellfish, amphibians, and other forms of aquatic animal

life.

(F) No person who offers raw agricultural commodities or raw fish to consumers may be

prosecuted for minor violations of this subparagraph if there has been substantial compliance

with the requirements of this paragraph.

(5)(A) Subparagraphs (1), (2), (3), and (4) shall not apply to food—

(i) which is served in restaurants or other establishments in which food is served for immediate

human consumption or which is sold for sale or use in such establishments,

(ii) which is processed and prepared primarily in a retail establishment, which is ready for

human consumption, which is of the type described in subclause (i), and which is offered for

sale to consumers but not for immediate human consumption in such establishment and which

is not offered for sale outside such establishment,

(iii) which is an infant formula subject to section 412,

(iv) which is a medical food as defined in section 5(b) of the Orphan Drug Act (21 U.S.C.

360ee(b)), or

(v) which is described in section 405(2).

(B) Subparagraphs (1) and (2) shall not apply to the label of a food if the Secretary determines

by regulations that compliance with such subparagraphs is impracticable because the

package of such food is too small to comply with the requirements of such subparagraphs and

if the label of such food does not contain any nutrition information.

(C) If a food contains insignificant amounts, as determined by the Secretary, of all the nutrients

required by subparagraphs (1) and (2) to be listed in the label or labeling of food, the

requirements of such subparagraphs shall not apply to such food if the label, labeling, or

advertising of such food does not make any claim with respect to the nutritional value of such

food. If a food contains insignificant amounts, as determined by the Secretary, of more than

one-half the nutrients required by subparagraphs (1) and (2) to be in the label or labeling of the

food, the Secretary shall require the amounts of such nutrients to be stated in a simplified form

prescribed by the Secretary.

(D) If a person offers food for sale and has annual gross sales made or business done in sales

to consumers which is not more than $500,000 or has annual gross sales made or business

done in sales of food to consumers which is not more than $50,000, the requirements of

subparagraphs (1), (2), (3), and (4) shall not apply with respect to food sold by such person to

consumers unless the label or labeling of food offered by such person provides nutrition

information or makes a nutrition claim.

(E)(i) During the 12-month period for which an exemption from subparagraphs (1) and (2) is

claimed pursuant to this subclause, the requirements of such subparagraphs shall not apply to

any food product if—

(I) the labeling for such product does not provide nutrition information or make a claim subject

to paragraph (r),

(II) the person who claims for such product an exemption from such subparagraphs employed

fewer than an average of 100 full-time equivalent employees,

(III) such person provided the notice described in subclause (iii), and

(IV) in the case of a food product which was sold in the 12-month period preceding the period

for which an exemption was claimed, fewer than 100,000 units of such product were sold in the

United States during such preceding period, or in the case of a food product which was not

sold in the 12-month period preceding the period for which such exemption is claimed, fewer

than 100,000 units of such product are reasonably anticipated to be sold in the United States

during the period for which such exemption is claimed.

(ii) During the 12-month period after the applicable date referred to in this sentence, the

requirements of subparagraphs (1) and (2) shall not apply to any food product which was first

introduced into interstate commerce before May 8, 1994, if the labeling for such product does

not provide nutrition information or make a claim subject to paragraph (r), if such person

provided the notice described in subclause (iii), and if—

(I) during the 12-month period preceding May 8, 1994, the person who claims for such product

an exemption from such subparagraphs employed fewer than an average of 300 full-time

equivalent employees and fewer than 600,000 units of such product were sold in the United

States,

(II) during the 12-month period preceding May 8, 1995, the person who claims for such product

an exemption from such subparagraphs employed fewer than an average of 300 full-time

equivalent employees and fewer than 400,000 units of such product were sold in the United

States, or

(III) during the 12-month period preceding May 8, 1996 , the person who claims for such

product an exemption from such subparagraphs employed fewer than an average of 200

full-time equivalent employees and fewer than 200,000 units of such product were sold in the

United States .

(iii) The notice referred to in subclauses (i) and (ii) shall be given to the Secretary prior to the

beginning of the period during which the exemption under subclause (i) or (ii) is to be in effect,

shall state that the person claiming such exemption for a food product has complied with the

applicable requirements of subclause (i) or (ii), and shall—

(I) state the average number of full-time equivalent employees such person employed during

the 12 months preceding the date such person claims such exemption,

(II) state the approximate number of units the person claiming the exemption sold in the United

States ,

(III) if the exemption is claimed for a food product which was sold in the 12-month period

preceding the period for which the exemption was claimed, state the approximate number of

units of such product which were sold in the United States during such preceding period, and,

if the exemption is claimed for a food product which was not sold in such preceding period,

state the number of units of such product which such person reasonably anticipates will be

sold in the United States during the period for which the exemption was claimed, and

(IV) contain such information as the Secretary may require to verify the information required by

the preceding provisions of this subclause if the Secretary has questioned the validity of such

information.

If a person is not an importer, has fewer than 10 full-time equivalent employees, and sells

fewer than 10,000 units of any food product in any year, such person is not required to file a

notice for such product under this subclause for such year.

(iv) In the case of a person who claimed an exemption under subclause (i) or (ii), if, during the

period of such exemption, the number of full-time equivalent employees of such person

exceeds the number in such subclause or if the number of food products sold in the United

States exceeds the number in such subclause, such exemption shall extend to the expiration

of 18 months after the date the number of full-time equivalent employees or food products sold

exceeded the applicable number.

(v) For any food product first introduced into interstate commerce after May 8, 2002 , the

Secretary may by regulation lower the employee or units of food products requirement of

subclause (i) if the Secretary determines that the cost of compliance with such lower

requirement will not place an undue burden on persons subject to such lower requirement.

(vi) For purposes of subclauses (i), (ii), (iii), (iv), and (v)—

(I) the term "unit" means the packaging or, if there is no packaging, the form in which a food

product is offered for sale to consumers,

(II) the term "food product" means food in any sized package which is manufactured by a

single manufacturer or which bears the same brand name, which bears the same statement of

identity, and which has similar preparation methods, and

(III) the term "person" in the case of a corporation includes all domestic and foreign affiliates of

the corporation.

(F) A dietary supplement product (including a food to which section 411 applies) shall comply

with the requirements of subparagraphs (1) and (2) in a manner which is appropriate for the

product and which is specified in regulations of the Secretary which shall provide that—

(i) nutrition information shall first list those dietary ingredients that are present in the product in

a significant amount and for which a recommendation for daily consumption has been

established by the Secretary, except that a dietary ingredient shall not be required to be listed

if it is not present in a significant amount, and shall list any other dietary ingredient present and

identified as having no such recommendation;

(ii) the listing of dietary ingredients shall include the quantity of each such ingredient (or of a

proprietary blend of such ingredients) per serving;

(iii) the listing of dietary ingredients may include the source of a dietary ingredient; and

(iv) the nutrition information shall immediately precede the ingredient information required

under subclause (i), except that no ingredient identified pursuant to subclause (i) shall be

required to be identified a second time.

(G) Subparagraphs (1), (2), (3), and (4) shall not apply to food which is sold by a food

distributor if the food distributor principally sells food to restaurants or other establishments in

which food is served for immediate human consumption and does not manufacture, process,

or repackage the food it sells.

(r) Nutrition levels and health-related claims.

(1) Except as provided in clauses (A) through (C) of subparagraph (5), if it is a food intended

for human consumption which is offered for sale and for which a claim is made in the label or

labeling of the food which expressly or by implication—

(A) characterizes the level of any nutrient which is of the type required by paragraph (q)(1) or

(q)(2) to be in the label or labeling of the food unless the claim is made in accordance with

subparagraph (2), or

(B) characterizes the relationship of any nutrient which is of the type required by paragraph

(q)(1) or (q)(2) to be in the label or labeling of the food to a disease or a health-related

condition unless the claim is made in accordance with subparagraph (3) or (5)(D).

A statement of the type required by paragraph (q) that appears as part of the nutrition

information required or permitted by such paragraph is not a claim which is subject to this

paragraph and a claim subject to clause (A) is not subject to clause (B).

(2)(A) Except as provided in subparagraphs (4)(A)(ii) and (4)(A)(iii) and clauses (A) through (C)

of subparagraph (5), a claim described in subparagraph (1)(A)—

(i) may be made only if the characterization of the level made in the claim uses terms which

are defined in regulations of the Secretary,

(ii) may not state the absence of a nutrient unless—

(I) the nutrient is usually present in the food or in a food which substitutes for the food as

defined by the Secretary by regulation, or

(II) the Secretary by regulation permits such a statement on the basis of a finding that such a

statement would assist consumers in maintaining healthy dietary practices and the statement

discloses that the nutrient is not usually present in the food,

(iii) may not be made with respect to the level of cholesterol in the food if the food contains, as

determined by the Secretary by regulation, fat or saturated fat in an amount which increases to

persons in the general population the risk of disease or a health related condition which is diet

related unless—

(I) the Secretary finds by regulation that the level of cholesterol is substantially less than the

level usually present in the food or in a food which substitutes for the food and which has a

significant market share, or the Secretary by regulation permits a statement regarding the

absence of cholesterol on the basis of a finding that cholesterol is not usually present in the

food and that such a statement would assist consumers in maintaining healthy dietary

practices and the regulation requires that the statement disclose that cholesterol is not usually

present in the food, and

(II) the label or labeling of the food discloses the level of such fat or saturated fat in immediate

proximity to such claim and with appropriate prominence which shall be no less than one-half

the size of the claim with respect to the level of cholesterol,

(iv) may not be made with respect to the level of saturated fat in the food if the food contains

cholesterol unless the label or labeling of the food discloses the level of cholesterol in the food

in immediate proximity to such claim and with appropriate prominence which shall be no less

than one-half the size of the claim with respect to the level of saturated fat,

(v) may not state that a food is high in dietary fiber unless the food is low in total fat as defined

by the Secretary or the label or labeling discloses the level of total fat in the food in immediate

proximity to such statement and with appropriate prominence which shall be no less than

one-half the size of the claim with respect to the level of dietary fiber, and

(vi) may not be made if the Secretary by regulation prohibits the claim because the claim is

misleading in light of the level of another nutrient in the food.

(B) If a claim described in subparagraph (1)(A) is made with respect to a nutrient in a food and

the Secretary makes a determination that the food contains a nutrient at a level that increases

to persons in the general population the risk of a disease or health-related condition that is diet

related, the label or labeling of such food shall contain, prominently and in immediate proximity

to such claim, the following statement: "See nutrition information for ---- content." The blank

shall identify the nutrient associated with the increased disease or health-related condition risk.

In making the determination described in this clause, the Secretary shall take into account the

significance of the food in the total daily diet.

(C) Subparagraph (2)(A) does not apply to a claim described in subparagraph (1)(A) and

contained in the label or labeling of a food if such claim is contained in the brand name of such

food and such brand name was in use on such food before October 25, 1989, unless the brand

name contains a term defined by the Secretary under subparagraph (2)(A)(i). Such a claim is

subject to paragraph (a).

(D) Subparagraph (2) does not apply to a claim described in subparagraph (1)(A) which uses

the term "diet" and is contained in the label or labeling of a soft drink if (i) such claim is

contained in the brand name of such soft drink, (ii) such brand name was in use on such soft

drink before October 25, 1989, and (iii) the use of the term "diet" was in conformity with section

105.66 of title 21 of the Code of Federal Regulations. Such a claim is subject to paragraph (a).

(E) Subclauses (i) through (v) of subparagraph (2)(A) do not apply to a statement in the label

or labeling of food which describes the percentage of vitamins and minerals in the food in

relation to the amount of such vitamins and minerals recommended for daily consumption by

the Secretary.

(F) Subclause (i) clause (A) does not apply to a statement in the labeling of a dietary

supplement that characterizes the percentage level of a dietary ingredient for which the

Secretary has not established a reference daily intake, daily recommended value, or other

recommendation for daily consumption.

(G) A claim of the type described in subparagraph (1)(A) for a nutrient, for which the Secretary

has not promulgated a regulation under clause (A)(i), shall be authorized and may be made

with respect to a food if—

(i) a scientific body of the United States Government with official responsibility for public health

protection or research directly relating to human nutrition (such as the National Institutes of

Health or the Centers for Disease Control and Prevention) or the National Academy of

Sciences or any of its subdivisions has published an authoritative statement, which is currently

in effect, which identifies the nutrient level to which the claim refers;

(ii) a person has submitted to the Secretary, at least 120 days (during which the Secretary may

notify any person who is making a claim as authorized by clause (C) that such person has not

submitted all the information required by such clause) before the first introduction into

interstate commerce of the food with a label containing the claim, (I) a notice of the claim,

which shall include the exact words used in the claim and shall include a concise description of

the basis upon which such person relied for determining that the requirements of subclause (i)

have been satisfied, (II) a copy of the statement referred to in subclause (i) upon which such

person relied in making the claim, and (III) a balanced representation of the scientific literature

relating to the nutrient level to which the claim refers;

(iii) the claim and the food for which the claim is made are in compliance with clauses (A) and

(B), and are otherwise in compliance with paragraph (a) and section 201(n); and

(iv) the claim is stated in a manner so that the claim is an accurate representation of the

authoritative statement referred to in subclause (i) and so that the claim enables the public to

comprehend the information provided in the claim and to understand the relative significance

of such information in the context of a total daily diet.

For purposes of this clause, a statement shall be regarded as an authoritative statement of a

scientific body described in subclause (i) only if the statement is published by the scientific

body and shall not include a statement of an employee of the scientific body made in the

individual capacity of the employee.

(H) A claim submitted under the requirements of clause (G) may be made until—

(i) such time as the Secretary issues a regulation—

(I) prohibiting or modifying the claim and the regulation has become effective, or

(II) finding that the requirements of clause (G) have not been met, including finding that the

petitioner had not submitted all the information required by such clause; or

(ii) a district court of the United States in an enforcement proceeding under chapter III has

determined that the requirements of clause (G) have not been met.

(3)(A) Except as provided in subparagraph (5), a claim described in subparagraph (1)(B) may

only be made—

(i) if the claim meets the requirements of the regulations of the Secretary promulgated under

clause (B), and

(ii) if the food for which the claim is made does not contain, as determined by the Secretary by

regulation, any nutrient in an amount which increases to persons in the general population the

risk of a disease or health-related condition which is diet related, taking into account the

significance of the food in the total daily diet, except that the Secretary may by regulation

permit such a claim based on a finding that such a claim would assist consumers in

maintaining healthy dietary practices and based on a requirement that the label contain a

disclosure of the type required by subparagraph (2)(B).

(B)(i) The Secretary shall promulgate regulations authorizing claims of the type described in

subparagraph (1)(B) only if the Secretary determines, based on the totality of publicly available

scientific evidence (including evidence from well-designed studies conducted in a manner

which is consistent with generally recognized scientific procedures and principles), that there is

significant scientific agreement, among experts qualified by scientific training and experience

to evaluate such claims, that the claim is supported by such evidence.

(ii) A regulation described in subclause (i) shall describe—

(I) the relationship between a nutrient of the type required in the label or labeling of food by

paragraph (q)(1) or (q)(2) and a disease or health-related condition, and

(II) the significance of each such nutrient in affecting such disease or health-related condition.

(iii) A regulation described in subclause (i) shall require such claim to be stated in a manner so

that the claim is an accurate representation of the matters set out in subclause (ii) and so that

the claim enables the public to comprehend the information provided in the claim and to

understand the relative significance of such information in the context of a total daily diet.

(C) Notwithstanding the provisions of clauses (A)(i) and (B), a claim of the type described in

subparagraph (1)(B) which is not authorized by the Secretary in a regulation promulgated in

accordance with clause (B) shall be authorized and may be made with respect to a food if—

(i) a scientific body of the United States Government with official responsibility for public health

protection or research directly relating to human nutrition (such as the National Institutes of

Health or the Centers for Disease Control and Prevention) or the National Academy of

Sciences or any of its subdivisions has published an authoritative statement, which is currently

in effect, about the relationship between a nutrient and a disease or health-related condition to

which the claim refers;

(ii) a person has submitted to the Secretary, at least 120 days (during which the Secretary may

notify any person who is making a claim as authorized by clause (C) that such person has not

submitted all the information required by such clause) before the first introduction into

interstate commerce of the food with a label containing the claim, (I) a notice of the claim,

which shall include the exact words used in the claim and shall include a concise description of

the basis upon which such person relied for determining that the requirements of subclause (i)

have been satisfied, (II) a copy of the statement referred to in subclause (i) upon which such

person relied in making the claim, and (III) a balanced representation of the scientific literature

relating to the relationship between a nutrient and a disease or health-related condition to

which the claim refers;

(iii) the claim and the food for which the claim is made are in compliance with clause (A)(ii) and

are otherwise in compliance with paragraph (a) and section 201(n); and

(iv) the claim is stated in a manner so that the claim is an accurate representation of the

authoritative statement referred to in subclause (i) and so that the claim enables the public to

comprehend the information provided in the claim and to understand the relative significance

of such information in the context of a total daily diet.

For purposes of this clause, a statement shall be regarded as an authoritative statement of a

scientific body described in subclause (i) only if the statement is published by the scientific

body and shall not include a statement of an employee of the scientific body made in the

individual capacity of the employee.

(D) A claim submitted under the requirements of clause (C) may be made until—

(i) such time as the Secretary issues a regulation under the standard in clause (B)(i)—

(I) prohibiting or modifying the claim and the regulation has become effective, or

(II) finding that the requirements of clause (C) have not been met, including finding that the

petitioner has not submitted all the information required by such clause; or

(ii) a district court of the United States in an enforcement proceeding under chapter III has

determined that the requirements of clause (C) have not been met.

(4)(A)(i) Any person may petition the Secretary to issue a regulation under subparagraph

(2)(A)(i) or (3)(B) relating to a claim described in subparagraph (1)(A) or (1)(B). Not later than

100 days after the petition is received by the Secretary, the Secretary shall issue a final

decision denying the petition or file the petition for further action by the Secretary. If the

Secretary does not act within such 100 days, the petition shall be deemed to be denied unless

an extension is mutually agreed upon by the Secretary and the petitioner. If the Secretary

denies the petition or the petition is deemed to be denied, the petition shall not be made

available to the public. If the Secretary files the petition, the Secretary shall deny the petition or

issue a proposed regulation to take the action requested in the petition not later than 90 days

after the date of such decision. If the Secretary does not act within such 90 days, the petition

shall be deemed to be denied unless an extension is mutually agreed upon by the Secretary

and the petitioner. If the Secretary issues a proposed regulation, the rulemaking shall be

completed within 540 days of the date the petition is received by the Secretary. If the Secretary

does not issue a regulation within such 540 days, the Secretary shall provide the Committee

on Commerce of the House of Representatives and the Committee on Labor and Human

Resources of the Senate the reasons action on the regulation did not occur within such 540

days.

(ii) Any person may petition the Secretary for permission to use in a claim described in

subparagraph (1)(A) terms that are consistent with the terms defined by the Secretary under

subparagraph (2)(A)(i). Within 90 days of the submission of such a petition, the Secretary shall

issue a final decision denying the petition or granting such permission.

(iii) Any person may petition the Secretary for permission to use an implied claim described in

subparagraph (1)(A) in a brand name. After publishing notice of an opportunity to comment on

the petition in the Federal Register and making the petition available to the public, the

Secretary shall grant the petition if the Secretary finds that such claim is not misleading and is

consistent with terms defined by the Secretary under subparagraph (2)(A)(i). The Secretary

shall grant or deny the petition within 100 days of the date it is submitted to the Secretary and

the petition shall be considered granted if the Secretary does not act on it within such 100

days.

(B) A petition under clause (A)(i) respecting a claim described in subparagraph (1)(A) or (1)(B)

shall include an explanation of the reasons why the claim meets the requirements of this

paragraph and a summary of the scientific data which supports such reasons.

(C) If a petition for a regulation under subparagraph (3)(B) relies on a report from an

authoritative scientific body of the United States, the Secretary shall consider such report and

shall justify any decision rejecting the conclusions of such report.

(5)(A) This paragraph does not apply to infant formulas subject to section 412(h) and medical

foods as defined in section 5(b) of the Orphan Drug Act.

(B) Subclauses (iii) through (v) of subparagraph (2)(A) and subparagraph (2)(B) do not apply

to food which is served in restaurants or other establishments in which food is served for

immediate human consumption or which is sold for sale or use in such establishments.

(C) A subparagraph (1)(A) claim made with respect to a food which claim is required by a

standard of identity issued under section 401 shall not be subject to subparagraph (2)(A)(i) or

(2)(B).

(D) A subparagraph (1)(B) claim made with respect to a dietary supplement of vitamins,

minerals, herbs, or other similar nutritional substances shall not be subject to subparagraph (3)

but shall be subject to a procedure and standard, respecting the validity of such claim,

established by regulation of the Secretary.

(6) For purposes of paragraph (r)(1)(B), a statement for a dietary supplement may be made

if—

(A) the statement claims a benefit related to a classical nutrient deficiency disease and

discloses the prevalence of such disease in the United States, describes the role of a nutrient

or dietary ingredient intended to affect the structure or function in humans, characterizes the

documented mechanism by which a nutrient or dietary ingredient acts to maintain such

structure or function, or describes general well-being from consumption of a nutrient or dietary

ingredient,

(B) the manufacturer of the dietary supplement has substantiation that such statement is

truthful and not misleading, and

(C) the statement contains, prominently displayed and in boldface type, the following: "This

statement has not been evaluated by the Food and Drug Administration. This product is not

intended to diagnose, treat, cure, or prevent any disease.".

A statement under this subparagraph may not claim to diagnose, mitigate, treat, cure, or

prevent a specific disease or class of diseases. If the manufacturer of a dietary supplement

proposes to make a statement described in the first sentence of this subparagraph in the

labeling of the dietary supplement, the manufacturer shall notify the Secretary no later than 30

days after the first marketing of the dietary supplement with such statement that such a

statement is being made.

(7) The Secretary may make proposed regulations issued under this paragraph effective upon

publication pending consideration of public comment and publication of a final regulation if the

Secretary determines that such action is necessary—

(A) to enable the Secretary to review and act promptly on petitions the Secretary determines

provide for information necessary to—

(i) enable consumers to develop and maintain healthy dietary practices;

(ii) enable consumers to be informed promptly and effectively of important new knowledge

regarding nutritional and health benefits of food; or

(iii) ensure that scientifically sound nutritional and health information is provided to consumers

as soon as possible; or

(B) to enable the Secretary to act promptly to ban or modify a claim under this paragraph.

Such proposed regulations shall be deemed final agency action for purposes of judicial review.

(s) Dietary supplements.

If—

(1) it is a dietary supplement; and

(2)(A) the label or labeling of the supplement fails to list—

(i) the name of each ingredient of the supplement that is described in section 201(ff); and

(ii)(I) the quantity of each such ingredient; or

(II) with respect to a proprietary blend of such ingredients, the total quantity of all ingredients in

the blend;

(B) the label or labeling of the dietary supplement fails to identify the product by using the term

"dietary supplement", which term may be modified with the name of such an ingredient;

(C) the supplement contains an ingredient described in section 201(ff)(1)(C), and the label or

labeling of the supplement fails to identify any part of the plant from which the ingredient is

derived;

(D) the supplement—

(i) is covered by the specifications of an official compendium;

(ii) is represented as conforming to the specifications of an official compendium; and

(iii) fails to so conform; or

(E) the supplement—

(i) is not covered by the specifications of an official compendium; and

(ii)(I) fails to have the identity and strength that the supplement is represented to have; or

(II) fails to meet the quality (including tablet or capsule disintegration), purity, or compositional

specifications, based on validated assay or other appropriate methods, that the supplement is

represented to meet.

A dietary supplement shall not be deemed misbranded solely because its label or labeling

contains directions or conditions of use or warnings.

(t) Catfish.10 If it purports to be or is represented as catfish, unless it is fish classified within the

family Ictaluridae.

(u) Ginseng. 11 If it purports to be or is represented as ginseng, unless it is an herb or herbal

ingredient derived from a plant classified within the genus Panax.

(v) Failure to label; health threat.

If--

(1) it fails to bear a label required by the Secretary under section 801(n)(1) (relating to food

refused admission into the United States );

(2) the Secretary finds that the food presents a threat of serious adverse health consequences

or death to humans or animals; and

(3) upon or after notifying the owner or consignee involved that the label is required under

section 801, the Secretary informs the owner or consignee that the food presents such a

threat.

(w) Major food allergen labeling requirements.

(1) 12, 13, 14, 15 If it is not a raw agricultural commodity and it is, or it contains an ingredient

that bears or contains, a major food allergen, unless either—

(A) the word 'Contains', followed by the name of the food source from which the major food

allergen is derived, is printed immediately after or is adjacent to the list of ingredients (in a type

size no smaller than the type size used in the list of ingredients) required under subsections (g)

and (i); or

(B) the common or usual name of the major food allergen in the list of ingredients required

under subsections (g) and (i) is followed in parentheses by the name of the food source from

which the major food allergen is derived, except that the name of the food source is not

required when—

(i) the common or usual name of the ingredient uses the name of the food source from which

the major food allergen is derived; or

(ii) the name of the food source from which the major food allergen is derived appears

elsewhere in the ingredient list, unless the name of the food source that appears elsewhere in

the ingredient list appears as part of the name of a food ingredient that is not a major food

allergen under section 201( qq)(2)(A) or (B).

(2) As used in this subsection, the term 'name of the food source from which the major food

allergen is derived' means the name described in section 201( qq)(1); provided that in the case

of a tree nut, fish, or Crustacean shellfish, the term 'name of the food source from which the

major food allergen is derived' means the name of the specific type of nut or species of fish or

Crustacean shellfish.

(3) The information required under this subsection may appear in labeling in lieu of appearing

on the label only if the Secretary finds that such other labeling is sufficient to protect the public

health. A finding by the Secretary under this paragraph (including any change in an earlier

finding under this paragraph) is effective upon publication in the Federal Register as a notice.

(4) Notwithstanding subsection (g), (i), or (k), or any other law, a flavoring, coloring, or

incidental additive that is, or that bears or contains, a major food allergen shall be subject to

the labeling requirements of this subsection.

(5) The Secretary may by regulation modify the requirements of subparagraph (A) or (B) of

paragraph (1), or eliminate either the requirement of subparagraph (A) or the requirements of

subparagraph (B) of paragraph (1), if the Secretary determines that the modification or

elimination of the requirement of subparagraph (A) or the requirements of subparagraph (B) is

necessary to protect the public health.

(6)(A) Any person may petition the Secretary to exempt a food ingredient described in section

201( qq)(2) from the allergen labeling requirements of this subsection.

(B) The Secretary shall approve or deny such petition within 180 days of receipt of the petition

or the petition shall be deemed denied, unless an extension of time is mutually agreed upon by

the Secretary and the petitioner.

(C) The burden shall be on the petitioner to provide scientific evidence (including the analytical

method used to produce the evidence) that demonstrates that such food ingredient, as derived

by the method specified in the petition, does not cause an allergic response that poses a risk

to human health.

(D) A determination regarding a petition under this paragraph shall constitute final agency

action.

(E) The Secretary shall promptly post to a public site all petitions received under this

paragraph within 14 days of receipt and the Secretary shall promptly post the Secretary's

response to each.

(7)(A) A person need not file a petition under paragraph (6) to exempt a food ingredient

described in section 201( qq)(2) from the allergen labeling requirements of this subsection, if

the person files with the Secretary a notification containing—

(i) scientific evidence (including the analytical method used) that demonstrates that the food

ingredient (as derived by the method specified in the notification, where applicable) does not

contain allergenic protein; or

(ii) a determination by the Secretary that the ingredient does not cause an allergic response

that poses a risk to human health under a premarket approval or notification program under

section 409.

(B) The food ingredient may be introduced or delivered for introduction into interstate

commerce as a food ingredient that is not a major food allergen 90 days after the date of

receipt of the notification by the Secretary, unless the Secretary determines within the 90-day

period that the notification does not meet the requirements of this paragraph, or there is

insufficient scientific evidence to determine that the food ingredient does not contain allergenic

protein or does not cause an allergenic response that poses a risk to human health.

(C) The Secretary shall promptly post to a public site all notifications received under this

subparagraph within 14 days of receipt and promptly post any objections thereto by the

Secretary.

(x) Nonmajor food allergen labeling requirements.16 Notwithstanding subsection (g), (i), or (k),

17 or any other law, a spice, flavoring, coloring, or incidental additive that is, or that bears or

contains, a food allergen (other than a major food allergen), as determined by the Secretary by

regulation, shall be disclosed in a manner specified by the Secretary by regulation.

(y) [Caution: This subsection is effective and applicable to any dietary supplement

labeled on or after the date that is 1 year after enactment, pursuant to § 3(d)(1), (2) of Act

Dec. 22, 2006, P.L. 109–462]. If it is a dietary supplement that is marketed in the United

States, unless the label of such dietary supplement includes a domestic address or domestic

phone number through which the responsible person (as described in section 761) may

receive a report of a serious adverse event with such dietary supplement.

SEC. 403A. 18 [21 U.S.C. 343–1] (a) Except as provided in subsection (b), no State or political

subdivision of a State may directly or indirectly establish under any authority or continue in

effect as to any food in interstate commerce—

(1) any requirement for a food which is the subject of a standard of identity established under

section 401 that is not identical to such standard of identity or that is not identical to the

requirement of section 403(g), except that this paragraph does not apply to a standard of

identity of a State or political subdivision of a State for maple syrup that is of the type required

by sections 401 and 403(g),

(2) any requirement for the labeling of food of the type required by section 403(c), 403(e), or

403(i)(2) 403(i)(2), 403(w), or 403(x) that is not identical to the requirement of such section,

except that this paragraph does not apply to a requirement of a State or political subdivision of

a State that is of the type required by section 403(c) and that is applicable to maple syrup,

(3) any requirement for the labeling of food of the type required by section 403(b), 403(d),

403(f), 403(h), 403(i)(1), or 403(k) that is not identical to the requirement of such section,

except that this paragraph does not apply to a requirement of a State or political subdivision of

a State that is of the type required by section 403(h)(1) and that is applicable to maple syrup,

(4) any requirement for nutrition labeling of food that is not identical to the requirement of

section 403(q), except a requirement for nutrition labeling of food which is exempt under

subclause (i) or (ii) of section 403(q)(5)(A), or

(5) any requirement respecting any claim of the type described in section 403(r)(1) made in the

label or labeling of foodthat is not identical to the requirement of section 403(r), except a

requirement respecting a claim made in the label or labeling of food which is exempt under

section 403(r)(5)(B).

Paragraph (3) shall take effect in accordance with section 6(b) of the Nutrition Labeling and

Education Act of 1990.

(b) Upon petition of a State or a political subdivision of a State, the Secretary may exempt from

subsection (a), under such conditions as may be prescribed by regulation, any State or local

requirement that—

(1) would not cause any food to be in violation of any applicable requirement under Federal

law,

(2) would not unduly burden interstate commerce, and

(3) is designed to address a particular need for information which need is not met by the

requirements of the sections referred to in subsection (a).

DIETARY SUPPLEMENT LABELING EXEMPTIONS

SEC. 403B. [21 U.S.C. 343–2] (a) IN GENERAL.—A publication, including an article, a

chapter in a book, or an official abstract of a peer-reviewed scientific publication that appears

in an article and was prepared by the author or the editors of the publication, which is reprinted

in its entirety, shall not be defined as labeling when used in connection with the sale of a

dietary supplement to consumers when it—

(1) is not false or misleading;

(2) does not promote a particular manufacturer or brand of a dietary supplement;

(3) is displayed or presented, or is displayed or presented with other such items on the same

subject matter, so as to present a balanced view of the available scientific information on a

dietary supplement;

(4) if displayed in an establishment, is physically separate from the dietary supplements; and

(5) does not have appended to it any information by sticker or any other method.

(b) APPLICATION.—Subsection (a) shall not apply to or restrict a retailer or wholesaler of

dietary supplements in any way whatsoever in the sale of books or other publications as a part

of the business of such retailer or wholesaler.

(c) BURDEN OF PROOF.—In any proceeding brought under subsection (a), the burden of

proof shall be on the United States to establish that an article or other such matter is false or

misleading.

DISCLOSURE

SEC. 403C. [21 U.S.C. 343–3] (a) No provision of section 201(n), 403(a), or 409 shall be

construed to require on the label or labeling of a food a separate radiation disclosure

statement that is more prominent than the declaration of ingredients required by section

403(i)(2).

(b) In this section, the term "radiation disclosure statement" means a written statement that

discloses that a food has been intentionally subject to radiation.

EMERGENCY PERMIT CONTROL

SEC. 404. [21 U.S.C. 344] (a) Whenever the Secretary finds after investigation that the

distribution in interstate commerce of any class of food may, by reason of contamination with

micro-organisms during the manufacture, processing, or packing thereof in any locality, be

injurious to health, and that such injurious nature cannot be adequately determined after such

articles have entered interstate commerce, he then, and in such case only, shall promulgate

regulations providing for the issuance, to manufacturers, processors, or packers of such class

of food in such locality of permits to which shall be attached such conditions governing the

manufacture, processing, or packaging of such class of food, for such temporary period of time,

as may be necessary to protect the public health; and after the effective date of such

regulations, and during such temporary period, no person shall introduce or deliver for

introduction into interstate commerce any such food manufactured, processed, or packed by

any such manufacturer, processor, or packer unless such manufacturer, processor, or packer

holds a permit issued by the Secretary as provided by such regulations.

(b) The Secretary is authorized to suspend immediately upon notice any permit issued under

authority of this section if it is found that any of the conditions of the permit have been violated.

The holder of a permit so suspended shall be privileged at any time to apply for the

reinstatement of such permit, and the Secretary shall, immediately after prompt hearing and

an inspection of the establishment, reinstate such permit if it is found that adequate measures

have been taken to comply with and maintain the conditions of the permit, as originally issued

or as amended.

(c) Any officer or employee duly designated by the Secretary shall have access to any factory

or establishment, the operator of which holds a permit from the Secretary, for the purpose of

ascertaining whether or not the conditions of the permit are being complied with, and denial of

access for such inspection shall be ground for suspension of the permit until such access is

freely given by the operator.

REGULATIONS MAKING EXEMPTIONS

SEC. 405. [21 U.S.C. 345] The Secretary shall promulgate regulations exempting from any

labeling requirement of this Act (1) small open containers of fresh fruits and fresh vegetables

and (2) food which is in accordance with the practice of the trade, to be processed, labeled, or

repacked in substantial quantities at establishments other than those where originally

processed or packed, or condition that such food is not adulterated or misbranded under the

provisions of this Act upon removal from such processing, labeling, or repacking establishment.

This section does not apply to the labeling requirements of sections 403(q) and 403(r).

TOLERANCES FOR POISONOUS INGREDIENTS IN FOOD

SEC. 406. 19 [21 U.S.C. 346] Any poisonous or deleterious substance added to any food,

except where such substance is required in the production thereof or cannot be avoided by

good manufacturing practice shall be deemed to be unsafe for purposes of the application of

clause 2)(A) of section 402(a); but when such substance is so required or cannot be so

avoided, the Secretary shall promulgate regulations limiting the quantity therein or thereon to

such extent as he finds necessary for the protection of public health, and any quantity

exceeding the limits so fixed shall also be deemed to be unsafe for purposes of the application

of clause (2)(A) of section 402(a). While such a regulation is in effect limiting the quantity of

any such substance in the case of any food, such food shall not, by reason of bearing or

containing any added amount of such substance, be considered to be adulterated within the

meaning of clause (1) of section 402(a). In determining the quantity of such added substance

to be tolerated in or on different articles of food the Secretary shall take into account the extent

to which the use of such substance is required or cannot be avoided in the production of each

such article, and the other ways in which the consumer may be affected by the same or other

poisonous or deleterious substances.

OLEOMARGARINE OR MARGARINE

SEC. 407. 20 [21 U.S.C. 347] (a) Colored oleomargarine or colored margarine which is sold in

the same State or Territory in which it is produced shall be subject in the same manner and to

the same extent to the provisions of this Act as if it had been introduced in interstate

commerce.

(b) No person shall sell, or offer for sale, colored oleomargarine or colored margarine unless—

(1) such oleomargarine or margarine is packaged,

(2) the net weight of the contents of any package sold in a retail establishment is one pound or

less,

(3) there appears on the label of the package (A) the word ‘‘oleomargarine’’ or ‘‘margarine’’ in

type or lettering at least as large as any other type or lettering on such label, and (B) a full and

accurate statement of all the ingredients contained in such oleomargarine, or margarine, and

(4) each part of the contents of the package is contained in a wrapper which bears the word

‘‘oleomargarine’’ or ‘‘margarine’’ in type or lettering not smaller than 20-point type.

The requirements of this subsection shall be in addition to and not in lieu of any of the other

requirements of this Act.

(c) No person shall possess in a form ready for serving colored oleomargarine or colored

margarine at a public eating place unless a notice that oleomargarine or margarine is served is

displayed prominently and conspicuously in such place and in such manner as to render it

likely to be read and understood by the ordinary individual being served in such eating place or

is printed or is otherwise set forth on the menu in type or lettering not smaller than that

normally used to designate the serving of other food items. No person shall serve colored

oleomargarine or colored margarine at a public eating place, whether or not any charge is

made therefore, unless (1) each separate serving bears or is accompanied by labeling

identifying it as oleomargarine or margarine, or (2) each separate serving thereof is triangular

in shape.

(d) Colored oleomargarine or colored margarine when served with meals at a public eating

place shall at the time of such service be exempt from the labeling requirements of section 403

(except (a) and 403 (f)) 21 if it complies with the requirements of subsection (b) of this section.

(e) For the purpose of this section colored oleomargarine or colored margarine is

oleomargarine or margarine having a tint or shade containing more than one and six-tenths

degrees of yellow, or of yellow and red collectively, but with an excess of yellow over red,

measured in terms of Lovibond tintometer scale or its equivalent.

TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES

SEC. 408. 22 [21 U.S.C. 346a] (a) REQUIREMENT FOR TOLERANCE OR EXEMPTION.—

(1) GENERAL RULE.—Except as provided in paragraph (2) or (3), any pesticide chemical

residue in or on a food shall be deemed unsafe for the purpose of section 402(a)(2)(B)

unless—

(A) a tolerance for such pesticide chemical residue in or on such food is in effect under this

section and the quantity of the residue is within the limits of the tolerance; or

(B) an exemption from the requirement of a tolerance is in effect under this section for the

pesticide chemical residue.

For the purposes of this section, the term ‘‘food’’, when used as a noun without modification,

shall mean a raw agricultural commodity or processed food.

(2) PROCESSED FOOD.—Notwithstanding paragraph (1)—

(A) if a tolerance is in effect under this section for a pesticide chemical residue in or on a raw

agricultural commodity, a pesticide chemical residue that is present in or on a processed food

because the food is made from that raw agricultural commodity shall not be considered unsafe

within the meaning of section 402(a)(2)(B) despite the lack of a tolerance for the pesticide

chemical residue in or on the processed food if the pesticide chemical has been used in or on

the raw agricultural commodity in conformity with a tolerance under this section, such residue

in or on the raw agricultural commodity has been removed to the extent possible in good

manufacturing practice, and the concentration of the pesticide chemical residue in the

processed food is not greater than the tolerance prescribed for the pesticide chemical residue

in the raw agricultural commodity; or

(B) if an exemption for the requirement for a tolerance is in effect under this section for a

pesticide chemical residue in or on a raw agricultural commodity, a pesticide chemical residue

that is present in or on a processed food because the food is made from that raw agricultural

commodity shall not be considered unsafe within the meaning of section 402(a)(2)(B).

(3) RESIDUES OF DEGRADATION PRODUCTS.—If a pesticide chemical residue is present

in or on a food because it is a metabolite or other degradation product of a precursor

substance that itself is a pesticide chemical or pesticide chemical residue, such a residue shall

not be considered to be unsafe within the meaning of section 402(a)(2)(B) despite the lack of a

tolerance or exemption from the need for a tolerance for such residue in or on such food if—

(A) the Administrator has not determined that the degradation product is likely to pose any

potential health risk from dietary exposure that is of a different type than, or of a greater

significance than, any risk posed by dietary exposure to the precursor substance;

(B) either—

(i) a tolerance is in effect under this section for residues of the precursor substance in or on the

food, and the combined level of residues of the degradation product and the precursor

substance in or on the food is at or below the stoichiometrically equivalent level that would be

permitted by the tolerance if the residue consisted only of the precursor substance rather than

the degradation product; or

(ii) an exemption from the need for a tolerance is in effect under this section for residues of the

precursor substance in or on the food; and

(C) the tolerance or exemption for residues of the precursor substance does not state that it

applies only to particular named substances and does not state that it does not apply to

residues of the degradation product.

(4) EFFECT OF TOLERANCE OR EXEMPTION.—While a tolerance or exemption from the

requirement for a tolerance is in effect under this section for a pesticide chemical residue with

respect to any food, the food shall not by reason of bearing or containing any amount of such a

residue be considered to be adulterated within the meaning of section 402(a)(1).

(b) AUTHORITY AND STANDARD FOR TOLERANCE.—

(1) AUTHORITY.—The Administrator may issue regulations establishing, modifying, or

revoking a tolerance for a pesticide chemical residue in or on a food—

(A) in response to a petition filed under subsection (d); or

(B) on the Administrator’s own initiative under subsection (e).

As used in this section, the term ‘‘modify’’ shall not mean expanding the tolerance to cover

additional foods.

(2) STANDARD.—

(A) GENERAL RULE.—

(i) STANDARD.—The Administrator may establish or leave in effect a tolerance for a pesticide

chemical residue in or on a food only if the Administrator determines that the tolerance is safe.

The Administrator shall modify or revoke a tolerance if the Administrator determines it is not

safe.

(ii) DETERMINATION OF SAFETY.—As used in this section, the term ‘‘safe’’, with respect to a

tolerance for a pesticide chemical residue, means that the Administrator has determined that

there is a reasonable certainty that no harm will result from aggregate exposure to the

pesticide chemical residue, including all anticipated dietary exposures and all other exposures

for which there is reliable information.

(iii) RULE OF CONSTRUCTION.—With respect to a tolerance, a pesticide chemical residue

meeting the standard under clause (i) is not an eligible pesticide chemical residue for purposes

of subparagraph (B).

(B) TOLERANCES FOR ELIGIBLE PESTICIDE CHEMICAL RESIDUES.—

(i) DEFINITION.—As used in this subparagraph, the term ‘‘eligible pesticide chemical residue’’

means a pesticide chemical residue as to which—

(I) the Administrator is not able to identify a level of exposure to the residue at which the

residue will not cause or contribute to a known or anticipated harm to human health (referred

to in this section as a ‘‘non-threshold effect’’);

(II) the lifetime risk of experiencing the non-threshold effect is appropriately assessed by

quantitative risk assessment; and

(III) with regard to any known or anticipated harm to human health for which the Administrator

is able to identify a level at which the residue will not cause such harm (referred to in this

section as a ‘‘threshold effect’’), the Administrator determines that the level of aggregate

exposure is safe.

(ii) DETERMINATION OF TOLERANCE.—Notwithstanding subparagraph (A)(i), a tolerance

for an eligible pesticide chemical residue may be left in effect or modified under this

subparagraph if—

(I) at least one of the conditions described in clause (iii) is met; and

(II) both of the conditions described in clause (iv) are met.

(iii) CONDITIONS REGARDING USE.—For purposes of clause (ii), the conditions described in

this clause with respect to a tolerance for an eligible pesticide chemical residue are the

following:

(I) Use of the pesticide chemical that produces the residue protects consumers from adverse

effects on health that would pose a greater risk than the dietary risk from the residue.

(II) Use of the pesticide chemical that produces the residue is necessary to avoid a significant

disruption in domestic production of an adequate, wholesome, and economical food supply.

(iv) CONDITIONS REGARDING RISK.—For purposes of clause (ii), the conditions described

in this clause with respect to a tolerance for an eligible pesticide chemical residue are the

following:

(I) The yearly risk associated with the nonthreshold effect from aggregate exposure to the

residue does not exceed 10 times the yearly risk that would be allowed under subparagraph (A)

for such effect.

(II) The tolerance is limited so as to ensure that the risk over a lifetime associated with the

nonthreshold effect from aggregate exposure to the residue is not greater than twice the

lifetime risk that would be allowed under subparagraph (A) for such effect.

(v) REVIEW.—Five years after the date on which the Administrator makes a determination to

leave in effect or modify a tolerance under this subparagraph, and thereafter as the

Administrator deems appropriate, the Administrator shall determine, after notice and

opportunity for comment, whether it has been demonstrated to the Administrator that a

condition described in clause (iii)(I) or clause (iii)(II) continues to exist with respect to the

tolerance and that the yearly and lifetime risks from aggregate exposure to such residue

continue to comply with the limits specified in clause (iv). If the Administrator determines by

such date that such demonstration has not been made, the Administrator shall, not later than

180 days after the date of such determination, issue a regulation under subsection (e)(1) to

modify or revoke the tolerance.

(vi) INFANTS AND CHILDREN.—Any tolerance under this subparagraph shall meet the

requirements of subparagraph (C).

(C) EXPOSURE OF INFANTS AND CHILDREN.—In establishing, modifying, leaving in effect,

or revoking a tolerance or exemption for a pesticide chemical residue, the Administrator—

(i) shall assess the risk of the pesticide chemical residue based on—

(I) available information about consumption patterns among infants and children that are likely

to result in disproportionately high consumption of foods containing or bearing such residue

among infants and children in comparison to the general population;

(II) available information concerning the special susceptibility of infants and children to the

pesticide chemical residues, including neurological differences between infants and children

and adults, and effects of in utero exposure to pesticide chemicals; and

(III) available information concerning the cumulative effects on infants and children of such

residues and other substances that have a common mechanism of toxicity; and

(ii) shall—

(I) ensure that there is a reasonable certainty that no harm will result to infants and children

from aggregate exposure to the pesticide chemical residue; and

(II) publish a specific determination regarding the safety of the pesticide chemical residue for

infants and children.

The Secretary of Health and Human Services and the Secretary of Agriculture, in consultation

with the Administrator, shall conduct surveys to document dietary exposure to pesticides

among infants and children. In the case of threshold effects, for purposes of clause (ii)(I) an

additional tenfold margin of safety for the pesticide chemical residue and other sources of

exposure shall be applied for infants and children to take into account potential pre- and

postnatal toxicity and completeness of the data with respect to exposure and toxicity to infants

and children. Notwithstanding such requirement for an additional margin of safety, the

Administrator may use a different margin of safety for the pesticide chemical residue only if, on

the basis of reliable data, such margin will be safe for infants and children.

(D) FACTORS.—In establishing, modifying, leaving in effect, or revoking a tolerance or

exemption for a pesticide chemical residue, the Administrator shall consider, among other

relevant factors—

(i) the validity, completeness, and reliability of the available data from studies of the pesticide

chemical and pesticide chemical residue;

(ii) the nature of any toxic effect shown to be caused by the pesticide chemical or pesticide

chemical residue in such studies;

(iii) available information concerning the relationship of the results of such studies to human

risk;

(iv) available information concerning the dietary consumption patterns of consumers (and

major identifiable subgroups of consumers);

(v) available information concerning the cumulative effects of such residues and other

substances that have a common mechanism of toxicity;

(vi) available information concerning the aggregate exposure levels of consumers (and major

identifiable subgroups of consumers) to the pesticide chemical residue and to other related

substances, including dietary exposure under the tolerance and all other tolerances in effect

for the pesticide chemical residue, and exposure from other non-occupational sources;

(vii) available information concerning the variability of the sensitivities of major identifiable

subgroups of consumers;

(viii) such information as the Administrator may require on whether the pesticide chemical may

have an effect in humans that is similar to an effect produced by a naturally occurring estrogen

or other endocrine effects; and

(ix) safety factors which in the opinion of experts qualified by scientific training and experience

to evaluate the safety of food additives are generally recognized as appropriate for the use of

animal experimentation data.

(E) DATA AND INFORMATION REGARDING ANTICIPATED AND ACTUAL RESIDUE

LEVELS.—

(i) AUTHORITY.—In establishing, modifying, leaving in effect, or revoking a tolerance for a

pesticide chemical residue, the Administrator may consider available data and information on

the anticipated residue levels of the pesticide chemical in or on food and the actual residue

levels of the pesticide chemical that have been measured in food, including residue data

collected by the Food and Drug Administration.

(ii) REQUIREMENT.—If the Administrator relies on anticipated or actual residue levels in

establishing, modifying, or leaving in effect a tolerance, the Administrator shall pursuant to

subsection (f)(1) require that data be provided five years after the date on which the tolerance

is established, modified, or left in effect, and thereafter as the Administrator deems appropriate,

demonstrating that such residue levels are not above the levels so relied on. If such data are

not so provided, or if the data do not demonstrate that the residue levels are not above the

levels so relied on, the Administrator shall, not later than 180 days after the date on which the

data were required to be provided, issue a regulation under subsection (e)(1), or an order

under subsection (f)(2), as appropriate, to modify or revoke the tolerance.

(F) PERCENT OF FOOD ACTUALLY TREATED.—In establishing, modifying, leaving in effect,

or revoking a tolerance for a pesticide chemical residue, the Administrator may, when

assessing chronic dietary risk, consider available data and information on the percent of food

actually treated with the pesticide chemical (including aggregate pesticide use data collected

by the Department of Agriculture) only if the Administrator—

(i) finds that the data are reliable and provide a valid basis to show what percentage of the food

derived from such crop is likely to contain such pesticide chemical residue;

(ii) finds that the exposure estimate does not understate exposure for any significant

subpopulation group;

(iii) finds that, if data are available on pesticide use and consumption of food in a particular

area, the population in such area is not dietarily exposed to residues above those estimated by

the Administrator; and

(iv) provides for the periodic reevaluation of the estimate of anticipated dietary exposure.

(3) DETECTION METHODS.—

(A) GENERAL RULE.—A tolerance for a pesticide chemical residue in or on a food shall not

be established or modified by the Administrator unless the Administrator determines, after

consultation with the Secretary, that there is a practical method for detecting and measuring

the levels of the pesticide chemical residue in or on the food.

(B) DETECTION LIMIT.—A tolerance for a pesticide chemical residue in or on a food shall not

be established at or modified to a level lower than the limit of detection of the method for

detecting and measuring the pesticide chemical residue specified by the Administrator under

subparagraph (A).

(4) INTERNATIONAL STANDARDS.—In establishing a tolerance for a pesticide chemical

residue in or on a food, the Administrator shall determine whether a maximum residue level for

the pesticide chemical has been established by the Codex Alimentarius Commission. If a

Codex maximum residue level has been established for the pesticide chemical and the

Administrator does not propose to adopt the Codex level, the Administrator shall publish for

public comment a notice explaining the reasons for departing from the Codex level.

(c) AUTHORITY AND STANDARD FOR EXEMPTIONS.—

(1) AUTHORITY.—The Administrator may issue a regulation establishing, modifying, or

revoking an exemption from the requirement for a tolerance for a pesticide chemical residue in

or on food—

(A) in response to a petition filed under subsection (d); or

(B) on the Administrator’s initiative under subsection (e).

(2) STANDARD.—

(A) GENERAL RULE.—

(i) STANDARD.—The Administrator may establish or leave in effect an exemption from the

requirement for a tolerance for a pesticide chemical residue in or on food only if the

Administrator determines that the exemption is safe. The Administrator shall modify or revoke

an exemption if the Administrator determines it is not safe.

(ii) DETERMINATION OF SAFETY.—The term ‘‘safe’’, with respect to an exemption for a

pesticide chemical residue, means that the Administrator has determined that there is a

reasonable certainty that no harm will result from aggregate exposure to the pesticide

chemical residue, including all anticipated dietary exposures and all other exposures for which

there is reliable information.

(B) FACTORS.—In making a determination under this paragraph, the Administrator shall take

into account, among other relevant considerations, the considerations set forth in

subparagraphs (C) and (D) of subsection (b)(2).

(3) LIMITATION.— An exemption from the requirement for a tolerance for a pesticide chemical

residue in or on food shall not be established or modified by the Administrator unless the

Administrator determines, after consultation with the Secretary—

(A) that there is a practical method for detecting and measuring the levels of such pesticide

chemical residue in or on food; or

(B) that there is no need for such a method, and states the reasons for such determination in

issuing the regulation establishing or modifying the exemption.

(d) PETITION FOR TOLERANCE OR EXEMPTION.—

(1) PETITIONS AND PETITIONERS.— Any person may file with the Administrator a petition

proposing the issuance of a regulation—

(A) establishing, modifying, or revoking a tolerance for a pesticide chemical residue in or on a

food; or

(B) establishing, modifying, or revoking an exemption from the requirement of a tolerance for

such a residue.

(2) PETITION CONTENTS.—

(A) ESTABLISHMENT.—A petition under paragraph (1) to establish a tolerance or exemption

for a pesticide chemical residue shall be supported by such data and information as are

specified in regulations issued by the Administrator, including—

(i)(I) an informative summary of the petition and of the data, information, and arguments

submitted or cited in support of the petition; and

(II) a statement that the petitioner agrees that such summary or any information it contains

may be published as a part of the notice of filing of the petition to be published under this

subsection and as part of a proposed or final regulation issued under this section;

(ii) the name, chemical identity, and composition of the pesticide chemical residue and of the

pesticide chemical that produces the residue;

(iii) data showing the recommended amount, frequency, method, and time of application of

that pesticide chemical; (iv) full reports of tests and investigations made with respect to the

safety of the pesticide chemical, including full information as to the methods and controls used

in conducting those tests and investigations;

(v) full reports of tests and investigations made with respect to the nature and amount of the

pesticide chemical residue that is likely to remain in or on the food, including a description of

the analytical methods used;

(vi) a practical method for detecting and measuring the levels of the pesticide chemical residue

in or on the food, or for exemptions, a statement why such a method is not needed;

(vii) a proposed tolerance for the pesticide chemical residue, if a tolerance is proposed;

(viii) if the petition relates to a tolerance for a processed food, reports of investigations

conducted using the processing method(s) used to produce that food;

(ix) such information as the Administrator may require to make the determination under

subsection (b)(2)(C);

(x) such information as the Administrator may require on whether the pesticide chemical may

have an effect in humans that is similar to an effect produced by a naturally occurring estrogen

or other endocrine effects;

(xi) information regarding exposure to the pesticide chemical residue due to any tolerance or

exemption already granted for such residue;

(xii) practical methods for removing any amount of the residue that would exceed any

proposed tolerance; and

(xiii) such other data and information as the Administrator requires by regulation to support the

petition.

If information or data required by this subparagraph is available to the Administrator, the

person submitting the petition may cite the availability of the information or data in lieu of

submitting it. The Administrator may require a petition to be accompanied by samples of the

pesticide chemical with respect to which the petition is filed.

(B) MODIFICATION OR REVOCATION.— The Administrator may by regulation establish the

requirements for information and data to support a petition to modify or revoke a tolerance or

to modify or revoke an exemption from the requirement for a tolerance.

(3) NOTICE.—A notice of the filing of a petition that the Administrator determines has met the

requirements of paragraph (2) shall be published by the Administrator within 30 days after

such determination. The notice shall announce the availability of a description of the analytical

methods available to the Administrator for the detection and measurement of the pesticide

chemical residue with respect to which the petition is filed or shall set forth the petitioner’s

statement of why such a method is not needed. The notice shall include the summary required

by paragraph (2)(A)(i)(I).

(4) ACTIONS BY THE ADMINISTRATOR.—

(A) IN GENERAL.—The Administrator shall, after giving due consideration to a petition filed

under paragraph (1) and any other information available to the Administrator—

(i) issue a final regulation (which may vary from that sought by the petition) establishing,

modifying, or revoking a tolerance for the pesticide chemical residue or an exemption of the

pesticide chemical residue from the requirement of a tolerance (which final regulation shall be

issued without further notice and without further period for public comment);

(ii) issue a proposed regulation under subsection (e), and thereafter issue a final regulation

under such subsection; or

(iii) issue an order denying the petition.

(B) PRIORITIES.—The Administrator shall give priority to petitions for the establishment or

modification of a tolerance or exemption for a pesticide chemical residue that appears to pose

a significantly lower risk to human health from dietary exposure than pesticide chemical

residues that have tolerances in effect for the same or similar uses.

(C) EXPEDITED REVIEW OF CERTAIN PETITIONS.—

(i) DATE CERTAIN FOR REVIEW.—If a person files a complete petition with the Administrator

proposing the issuance of a regulation establishing a tolerance or exemption for a pesticide

chemical residue that presents a lower risk to human health than a pesticide chemical residue

for which a tolerance has been left in effect or modified under subsection (b)(2)(B), the

Administrator shall complete action on such petition under this paragraph within 1 year.

(ii) REQUIRED DETERMINATIONS.—If the Administrator issues a final regulation

establishing a tolerance or exemption for a safer pesticide chemical residue under clause (i),

the Administrator shall, not later than 180 days after the date on which the regulation is issued,

determine whether a condition described in subclause (I) or (II) of subsection (b)(2)(B)(iii)

continues to exist with respect to a tolerance that has been left in effect or modified under

subsection (b)(2)(B). If such condition does not continue to exist, the Administrator shall, not

later than 180 days after the date on which the determination under the preceding sentence is

made, issue a regulation under subsection (e)(1) to modify or revoke the tolerance.

(e) ACTION ON ADMINISTRATOR’S OWN INITIATIVE.—

(1) GENERAL RULE.—The Administrator may issue a regulation—

(A) establishing, modifying, suspending under subsection (l)(3), or revoking a tolerance for a

pesticide chemical or a pesticide chemical residue;

(B) establishing, modifying, suspending under subsection (l)(3), or revoking an exemption of a

pesticide chemical residue from the requirement of a tolerance; or

(C) establishing general procedures and requirements to implement this section.

(2) NOTICE.—Before issuing a final regulation under paragraph (1), the Administrator shall

issue a notice of proposed rulemaking and provide a period of not less than 60 days for public

comment on the proposed regulation, except that a shorter period for comment may be

provided if the Administrator for good cause finds that it would be in the public interest to do so

and states the reasons for the finding in the notice of proposed rulemaking.

(f) SPECIAL DATA REQUIREMENTS.—

(1) REQUIRING SUBMISSION OF ADDITIONAL DATA.—If the Administrator determines that

additional data or information are reasonably required to support the continuation of a

tolerance or exemption that is in effect under this section for a pesticide chemical residue on a

food, the Administrator shall—

(A) issue a notice requiring the person holding the pesticide registrations associated with such

tolerance or exemption to submit the data or information under section 3(c)(2)(B) of the

Federal Insecticide, Fungicide, and Rodenticide Act;

(B) issue a rule requiring that testing be conducted on a substance or mixture under section 4

of the Toxic Substances Control Act; or

(C) publish in the Federal Register, after first providing notice and an opportunity for comment

of not less than 60 days’ duration, an order—

(i) requiring the submission to the Administrator by one or more interested persons of a notice

identifying the person or persons who will submit the required data and information;

(ii) describing the type of data and information required to be submitted to the Administrator

and stating why the data and information could not be obtained under the authority of section

3(c)(2)(B) of the Federal Insecticide, Fungicide, and Rodenticide Act or section 4 of the Toxic

Substances Control Act;

(iii) describing the reports of the Administrator required to be prepared during and after the

collection of the data and information;

(iv) requiring the submission to the Administrator of the data, information, and reports referred

to in clauses (ii) and (iii); and

(v) establishing dates by which the submissions described in clauses (i) and (iv) must be

made.

The Administrator may under subparagraph (C) revise any such order to correct an error. The

Administrator may under this paragraph require data or information pertaining to whether the

pesticide chemical may have an effect in humans that is similar to an effect produced by a

naturally occurring estrogen or other endocrine effects.

(2) NONCOMPLIANCE.—If a submission required by a notice issued in accordance with

paragraph (1)(A), a rule issued under paragraph (1)(B), or an order issued under paragraph

(1)(C) is not made by the time specified in such notice, rule, or order, the Administrator may by

order published in the Federal Register modify or revoke the tolerance or exemption in

question. In any review of such an order under subsection (g)(2), the only material issue shall

be whether a submission required under paragraph (1) was not made by the time specified.

(g) EFFECTIVE DATE, OBJECTIONS, HEARINGS, AND ADMINISTRATIVE REVIEW.—

(1) EFFECTIVE DATE.—A regulation or order issued under subsection (d)(4), (e)(1), or (f)(2)

shall take effect upon publication unless the regulation or order specifies otherwise. The

Administrator may stay the effectiveness of the regulation or order if, after issuance of such

regulation or order, objections are filed with respect to such regulation or order pursuant to

paragraph (2).

(2) FURTHER PROCEEDINGS.—

(A) OBJECTIONS.—Within 60 days after a regulation or order is issued under subsection

(d)(4), (e)(1)(A), (e)(1)(B), (f)(2), (n)(3), or (n)(5)(C), any person may file objections thereto with

the Administrator, specifying with particularity the provisions of the regulation or order deemed

objectionable and stating reasonable grounds therefor. If the regulation or order was issued in

response to a petition under subsection (d)(1), a copy of each objection filed by a person other

than the petitioner shall be served by the Administrator on the petitioner.

(B) HEARING.—An objection may include a request for a public evidentiary hearing upon the

objection. The Administrator shall, upon the initiative of the Administrator or upon the request

of an interested person and after due notice, hold a public evidentiary hearing if and to the

extent the Administrator determines that such a public hearing is necessary to receive factual

evidence relevant to material issues of fact raised by the objections. The presiding officer in

such a hearing may authorize a party to obtain discovery from other persons and may upon a

showing of good cause made by a party issue a subpoena to compel testimony or production

of documents from any person. The presiding officer shall be governed by the Federal Rules of

Civil Procedure in making any order for the protection of the witness or the content of

documents produced and shall order the payment of reasonable fees and expenses as a

condition to requiring testimony of the witness. On contest, such a subpoena may be enforced

by a Federal district court.

(C) FINAL DECISION.—As soon as practicable after receiving the arguments of the parties,

the Administrator shall issue an order stating the action taken upon each such objection and

setting forth any revision to the regulation or prior order that the Administrator has found to be

warranted. If a hearing was held under subparagraph (B), such order and any revision to the

regulation or prior order shall, with respect to questions of fact at issue in the hearing, be

based only on substantial evidence of record at such hearing, and shall set forth in detail the

findings of facts and the conclusions of law or policy upon which the order or regulation is

based.

(h) JUDICIAL REVIEW.—

(1) PETITION.—In a case of actual controversy as to the validity of any regulation issued

under subsection (e)(1)(C), or any order issued under subsection (f)(1)(C) or (g)(2)(C), or any

regulation that is the subject of such an order, any person who will be adversely affected by

such order or regulation may obtain judicial review by filing in the United States Court of

Appeals for the circuit wherein that person resides or has its principal place of business, or in

the United States Court of Appeals for the District of Columbia Circuit, within 60 days after

publication of such order or regulation, a petition praying that the order or regulation be set

aside in whole or in part.

(2) RECORD AND JURISDICTION.—A copy of the petition under paragraph (1) shall be

forthwith transmitted by the clerk of the court to the Administrator, or any officer designated by

the Administrator for that purpose, and thereupon the Administrator shall file in the court the

record of the proceedings on which the Administrator based the order or regulation, as

provided in section 2112 of title 28, United States Code. Upon the filing of such a petition, the

court shall have exclusive jurisdiction to affirm or set aside the order or regulation complained

of in whole or in part. As to orders issued following a public evidentiary hearing, the findings of

the Administrator with respect to questions of fact shall be sustained only if supported by

substantial evidence when considered on the record as a whole.

(3) ADDITIONAL EVIDENCE.—If a party applies to the court for leave to adduce additional

evidence and shows to the satisfaction of the court that the additional evidence is material and

that there were reasonable grounds for the failure to adduce the evidence in the proceeding

before the Administrator, the court may order that the additional evidence (and evidence in

rebuttal thereof) shall be taken before the Administrator in the manner and upon the terms and

conditions the court deems proper. The Administrator may modify prior findings as to the facts

by reason of the additional evidence so taken and may modify the order or regulation

accordingly. The Administrator shall file with the court any such modified finding, order, or

regulation.

(4) FINAL JUDGMENT; SUPREME COURT REVIEW.—The judgment of the court affirming or

setting aside, in whole or in part, any regulation or any order and any regulation which is the

subject of such an order shall be final, subject to review by the Supreme Court of the United

States as provided in section 1254 of title 28 of the United States Code. The commencement

of proceedings under this subsection shall not, unless specifically ordered by the court to the

contrary, operate as a stay of a regulation or order.

(5) APPLICATION.—Any issue as to which review is or was obtainable under this subsection

shall not be the subject of judicial review under any other provision of law.

(i) CONFIDENTIALITY AND USE OF DATA.—

(1) GENERAL RULE.—Data and information that are or have been submitted to the

Administrator under this section or section 409 in support of a tolerance or an exemption from

a tolerance shall be entitled to confidential treatment for reasons of business confidentiality

and to exclusive use and data compensation to the same extent provided by sections 3 and 10

of the Federal Insecticide, Fungicide, and Rodenticide Act.

(2) EXCEPTIONS.—

(A) IN GENERAL.—Data and information that are entitled to confidential treatment under

paragraph (1) may be disclosed, under such security requirements as the Administrator may

provide by regulation, to—

(i) employees of the United States authorized by the Administrator to examine such data and

information in the carrying out of their official duties under this Act or other Federal statutes

intended to protect the public health; or

(ii) contractors with the United States authorized by the Administrator to examine such data

and information in the carrying out of contracts under this Act or such statutes.

(B) CONGRESS.—This subsection does not authorize the withholding of data or information

from either House of Congress or from, to the extent of matter within its jurisdiction, any

committee or subcommittee of such committee or any joint committee of Congress or any

subcommittee of such joint committee.

(3) SUMMARIES.—Notwithstanding any provision of this subsection or other law, the

Administrator may publish the informative summary required by subsection (d)(2)(A)(i) and

may, in issuing a proposed or final regulation or order under this section, publish an

informative summary of the data relating to the regulation or order.

(j) STATUS OF PREVIOUSLY ISSUED REGULATIONS.—

(1) REGULATIONS UNDER SECTION 406.—Regulations affecting pesticide chemical

residues in or on raw agricultural commodities promulgated, in accordance with section 701(e),

under the authority of section 406(a) upon the basis of public hearings instituted before

January 1, 1953, shall be deemed to be regulations issued under this section and shall be

subject to modification or revocation under subsections (d) and (e), and shall be subject to

review under subsection (q).

(2) REGULATIONS UNDER SECTION 409.—Regulations that established tolerances for

substances that are pesticide chemical residues in or on processed food, or that otherwise

stated the conditions under which such pesticide chemicals could be safely used, and that

were issued under section 409 on or before the date of the enactment of this paragraph, shall

be deemed to be regulations issued under this section and shall be subject to modification or

revocation under subsection (d) or (e), and shall be subject to review under subsection (q).

(3) REGULATIONS UNDER SECTION 408.—Regulations that established tolerances or

exemptions under this section that were issued on or before the date of the enactment of this

paragraph shall remain in effect unless modified or revoked under subsection (d) or (e), and

shall be subject to review under subsection (q).

(4) CERTAIN SUBSTANCES.—With respect to a substance that is not included in the

definition of the term ‘pesticide chemical’ under section 201(q)(1) but was so included on the

day before the date of the enactment of the Antimicrobial Regulation Technical Corrections Act

of 1998, the following applies as of such date of enactment:

(A) Notwithstanding paragraph (2), any regulation applying to the use of the substance that

was in effect on the day before such date, and was on such day deemed in such paragraph to

have been issued under this section, shall be considered to have been issued under section

409.

(B) Notwithstanding paragraph (3), any regulation applying to the use of the substance that

was in effect on such day and was issued under this section (including any such regulation

issued before the date of the enactment of the Food Quality Protection Act of 1996) is deemed

to have been issued under section 409.

(k) TRANSITIONAL PROVISION.—If, on the day before the date of the enactment of this

subsection, a substance that is a pesticide chemical was, with respect to a particular pesticidal

use of the substance and any resulting pesticide chemical residue in or on a particular food—

(1) regarded by the Administrator or the Secretary as generally recognized as safe for use

within the meaning of the provisions of subsection (a) or section 201(s) as then in effect; or

(2) regarded by the Secretary as a substance described by section 201(s)(4); such a pesticide

chemical residue shall be regarded as exempt from the requirement for a tolerance, as of the

date of enactment of this subsection. The Administrator shall by regulation indicate which

substances are described by this subsection. Any exemption under this subsection may be

modified or revoked as if it had been issued under subsection (c).

(l) HARMONIZATION WITH ACTION UNDER OTHER LAWS.—

(1) COORDINATION WITH FIFRA.—To the extent practicable and consistent with the review

deadlines in subsection (q), in issuing a final rule under this subsection that suspends or

revokes a tolerance or exemption for a pesticide chemical residue in or on food, the

Administrator shall coordinate such action with any related necessary action under the Federal

Insecticide, Fungicide, and Rodenticide Act.

(2) REVOCATION OF TOLERANCE OR EXEMPTION FOLLOWING CANCELLATION OF

ASSOCIATED REGISTRATIONS.—If the Administrator, acting under the Federal Insecticide,

Fungicide, and Rodenticide Act, cancels the registration of each pesticide that contains a

particular pesticide chemical and that is labeled for use on a particular food, or requires that

the registration of each such pesticide be modified to prohibit its use in connection with the

production, storage, or transportation of such food, due in whole or in part to dietary risks to

humans posed by residues of that pesticide chemical on that food, the Administrator shall

revoke any tolerance or exemption that allows the presence of the pesticide chemical, or any

pesticide chemical residue that results from its use, in or on that food. Subsection (e) shall

apply to actions taken under this paragraph. A revocation under this paragraph shall become

effective not later than 180 days after—

(A) the date by which each such cancellation of a registration has become effective; or

(B) the date on which the use of the canceled pesticide becomes unlawful under the terms of

the cancellation, whichever is later.

(3) SUSPENSION OF TOLERANCE OR EXEMPTION FOLLOWING SUSPENSION OF

ASSOCIATED REGISTRATIONS.—

(A) SUSPENSION.—If the Administrator, acting under the Federal Insecticide, Fungicide, and

Rodenticide Act, suspends the use of each registered pesticide that contains a particular

pesticide chemical and that is labeled for use on a particular food, due in whole or in part to

dietary risks to humans posed by residues of that pesticide chemical on that food, the

Administrator shall suspend any tolerance or exemption that allows the presence of the

pesticide chemical, or any pesticide chemical residue that results from its use, in or on that

food. Subsection (e) shall apply to actions taken under this paragraph. A suspension under

this paragraph shall become effective not later than 60 days after the date by which each such

suspension of use has become effective.

(B) EFFECT OF SUSPENSION.—The suspension of a tolerance or exemption under

subparagraph (A) shall be effective as long as the use of each associated registration of a

pesticide is suspended under the Federal Insecticide, Fungicide, and Rodenticide Act. While a

suspension of a tolerance or exemption is effective the tolerance or exemption shall not be

considered to be in effect. If the suspension of use of the pesticide under that Act is terminated,

leaving the registration of the pesticide for such use in effect under that Act, the Administrator

shall rescind any associated suspension of tolerance or exemption.

(4) TOLERANCES FOR UNAVOIDABLE RESIDUES.—In connection with action taken under

paragraph (2) or (3), or with respect to pesticides whose registrations were suspended or

canceled prior to the date of the enactment of this paragraph under the Federal Insecticide,

Fungicide, and Rodenticide Act, if the Administrator determines that a residue of the canceled

or suspended pesticide chemical will unavoidably persist in the environment and thereby be

present in or on a food, the Administrator may establish a tolerance for the pesticide chemical

residue. In establishing such a tolerance, the Administrator shall take into account both the

factors set forth in subsection (b)(2) and the unavoidability of the residue. Subsection (e) shall

apply to the establishment of such tolerance. The Administrator shall review any such

tolerance periodically and modify it as necessary so that it allows no greater level of the

pesticide chemical residue than is unavoidable.

(5) PESTICIDE RESIDUES RESULTING FROM LAWFUL APPLICATION OF

PESTICIDE.—Notwithstanding any other provision of this Act, if a tolerance or exemption for a

pesticide chemical residue in or on a food has been revoked, suspended, or modified under

this section, an article of that food shall not be deemed unsafe solely because of the presence

of such pesticide chemical residue in or on such food if it is shown to the satisfaction of the

Secretary that—

(A) the residue is present as the result of an application or use of a pesticide at a time and in a

manner that was lawful under the Federal Insecticide, Fungicide, and Rodenticide Act; and

(B) the residue does not exceed a level that was authorized at the time of that application or

use to be present on the food under a tolerance, exemption, food additive regulation, or other

sanction then in effect under this Act; unless, in the case of any tolerance or exemption

revoked, suspended, or modified under this subsection or subsection (d) or (e), the

Administrator has issued a determination that consumption of the legally treated food during

the period of its likely availability in commerce will pose an unreasonable dietary risk.

(6) TOLERANCE FOR USE OF PESTICIDES UNDER AN EMERGENCY EXEMPTION.—If

the Administrator grants an exemption under section 18 of the Federal Insecticide, Fungicide,

and Rodenticide Act (7 U.S.C. 136p) for a pesticide chemical, the Administrator shall establish

a tolerance or exemption from the requirement for a tolerance for the pesticide chemical

residue. Such a tolerance or exemption from a tolerance shall have an expiration date. The

Administrator may establish such a tolerance or exemption without providing notice or a period

for comment on the tolerance or exemption. The Administrator shall promulgate regulations

within 365 days after the date of the enactment of this paragraph governing the establishment

of tolerances and exemptions under this paragraph. Such regulations shall be consistent with

the safety standard under subsections (b)(2) and (c)(2) and with section 18 of the Federal

Insecticide, Fungicide, and Rodenticide Act.

(m) 23 FEES.—

(1) AMOUNT.—The Administrator shall by regulation require the payment of such fees as will

in the aggregate, in the judgment of the Administrator, be sufficient over a reasonable term to

provide, equip, and maintain an adequate service for the performance of the Administrator’s

functions under this section. Under the regulations, the performance of the Administrator’s

services or other functions under this section, including—

(A) the acceptance for filing of a petition submitted under subsection (d);

(B) establishing, modifying, leaving in effect, or revoking a tolerance or establishing, modifying,

leaving in effect, or revoking an exemption from the requirement for a tolerance under this

section;

(C) the acceptance for filing of objections under subsection (g); or

(D) the certification and filing in court of a transcript of the proceedings and the record under

subsection (h); may be conditioned upon the payment of such fees. The regulations may

further provide for waiver or refund of fees in whole or in part when in the judgment of the

Administrator such a waiver or refund is equitable and not contrary to the purposes of this

subsection.

(2) DEPOSIT.—All fees collected under paragraph (1) shall be deposited in the Reregistration

and Expedited Processing Fund created by section 4(k) of the Federal Insecticide, Fungicide,

and Rodenticide Act. Such fees shall be available to the Administrator, without fiscal year

limitation, for the performance of the Administrator’s services or functions as specified in

paragraph (1).

(n) NATIONAL UNIFORMITY OF TOLERANCES.—

(1) QUALIFYING PESTICIDE CHEMICAL RESIDUE.—For purposes of this subsection, the

term ‘‘qualifying pesticide chemical residue’’ means a pesticide chemical residue resulting

from the use, in production, processing, or storage of a food, of a pesticide chemical that is an

active ingredient and that—

(A) was first approved for such use in a registration of a pesticide issued under section 3(c)(5)

of the Federal Insecticide, Fungicide, and Rodenticide Act on or after April 25, 1985, on the

basis of data determined by the Administrator to meet all applicable requirements for data

prescribed by regulations in effect under that Act on April 25, 1985; or

(B) was approved for such use in a reregistration eligibility determination issued under section

4(g) of that Act on or after the date of enactment of this subsection.

(2) QUALIFYING FEDERAL DETERMINATION.—For purposes of this subsection, the term

‘‘qualifying Federal determination’’ means a tolerance or exemption from the requirement for a

tolerance for a qualifying pesticide chemical residue that—

(A) is issued under this section after the date of the enactment of this subsection and

determined by the Administrator to meet the standard under subsection (b)(2)(A) (in the case

of a tolerance) or (c)(2) (in the case of an exemption); or

(B)(i) pursuant to subsection (j) is remaining in effect or is deemed to have been issued under

this section, or is regarded under subsection (k) as exempt from the requirement for a

tolerance; and

(ii) is determined by the Administrator to meet the standard under subsection (b)(2)(A) (in the

case of a tolerance) or (c)(2) (in the case of an exemption).

(3) LIMITATION.—The Administrator may make the determination described in paragraph

(2)(B)(ii) only by issuing a rule in accordance with the procedure set forth in subsection (d) or

(e) and only if the Administrator issues a proposed rule and allows a period of not less than 30

days for comment on the proposed rule. Any such rule shall be reviewable in accordance with

subsections (g) and (h).

(4) STATE AUTHORITY.—Except as provided in paragraphs (5), (6), and (8) no State or

political subdivision may establish or enforce any regulatory limit on a qualifying pesticide

chemical residue in or on any food if a qualifying Federal determination applies to the

presence of such pesticide chemical residue in or on such food, unless such State regulatory

limit is identical to such qualifying Federal determination. A State or political subdivision shall

be deemed to establish or enforce a regulatory limit on a pesticide chemical residue in or on a

food if it purports to prohibit or penalize the production, processing, shipping, or other handling

of a food because it contains a pesticide residue (in excess of a prescribed limit).

(5) PETITION PROCEDURE.—

(A) IN GENERAL.—Any State may petition the Administrator for authorization to establish in

such State a regulatory limit on a qualifying pesticide chemical residue in or on any food that is

not identical to the qualifying Federal determination applicable to such qualifying pesticide

chemical residue.

(B) PETITION REQUIREMENTS.—Any petition under subparagraph (A) shall—

(i) satisfy any requirements prescribed, by rule, by the Administrator; and

(ii) be supported by scientific data about the pesticide chemical residue that is the subject of

the petition or about chemically related pesticide chemical residues, data on the consumption

within such State of food bearing the pesticide chemical residue, and data on exposure of

humans within such State to the pesticide chemical residue.

(C) AUTHORIZATION.—The Administrator may, by order, grant the authorization described in

subparagraph (A) if the Administrator determines that the proposed State regulatory limit—

(i) is justified by compelling local conditions; and

(ii) would not cause any food to be a violation of Federal law.

(D) TREATMENT.—In lieu of any action authorized under subparagraph (C), the Administrator

may treat a petition under this paragraph as a petition under subsection (d) to modify or revoke

a tolerance or an exemption. If the Administrator determines to treat a petition under this

paragraph as a petition under subsection (d), the Administrator shall thereafter act on the

petition pursuant to subsection (d).

(E) REVIEW.—Any order of the Administrator granting or denying the authorization described

in subparagraph (A) shall be subject to review in the manner described in subsections (g) and

(h).

(6) URGENT PETITION PROCEDURE.—Any State petition to the Administrator pursuant to

paragraph (5) that demonstrates that consumption of a food containing such pesticide residue

level during the period of the food’s likely availability in the State will pose a significant public

health threat from acute exposure shall be considered an urgent petition. If an order by the

Administrator to grant or deny the requested authorization in an urgent petition is not made

within 30 days of receipt of the petition, the petitioning State may establish and enforce a

temporary regulatory limit on a qualifying pesticide chemical residue in or on the food. The

temporary regulatory limit shall be validated or terminated by the Administrator’s final order on

the petition.

(7) RESIDUES FROM LAWFUL APPLICATION.—No State or political subdivision may

enforce any regulatory limit on the level of a pesticide chemical residue that may appear in or

on any food if, at the time of the application of the pesticide that resulted in such residue, the

sale of such food with such residue level was lawful under this section and under the law of

such State, unless the State demonstrates that consumption of the food containing such

pesticide residue level during the period of the food’s likely availability in the State will pose an

unreasonable dietary risk to the health of persons within such State.

(8) SAVINGS.—Nothing in this Act preempts the authority of any State or political subdivision

to require that a food containing a pesticide chemical residue bear or be the subject of a

warning or other statement relating to the presence of the pesticide chemical residue in or on

such food.

(o) CONSUMER RIGHT TO KNOW.—Not later than 2 years after the date of the enactment of

the Food Quality Protection Act of 1996, and annually thereafter, the Administrator shall, in

consultation with the Secretary of Agriculture and the Secretary of Health and Human Services,

publish in a format understandable to a lay person, and distribute to large retail grocers for

public display (in a manner determined by the grocer), the following information, at a minimum:

(1) A discussion of the risks and benefits of pesticide chemical residues in or on food

purchased by consumers.

(2) A listing of actions taken under subparagraph (B) of subsection (b)(2) that may result in

pesticide chemical residues in or on food that present a yearly or lifetime risk above the risk

allowed under subparagraph (A) of such subsection, and the food on which the pesticide

chemicals producing the residues are used.

(3) Recommendations to consumers for reducing dietary exposure to pesticide chemical

residues in a manner consistent with maintaining a healthy diet, including a list of food that

may reasonably substitute for food listed under paragraph (2).

Nothing 24 in this subsection shall prevent retail grocers from providing additional information.

(p) ESTROGENIC SUBSTANCES SCREENING PROGRAM.—

(1) DEVELOPMENT.—Not later than 2 years after the date of enactment of this section, the

Administrator shall in consultation with the Secretary of Health and Human Services develop a

screening program, using appropriate validated test systems and other scientifically relevant

information, to determine whether certain substances may have an effect in humans that is

similar to an effect produced by a naturally occurring estrogen, or such other endocrine effect

as the Administrator may designate.

(2) IMPLEMENTATION.—Not later than 3 years after the date of enactment of this section,

after obtaining public comment and review of the screening program described in paragraph (1)

by the scientific advisory panel established under section 25(d) of the Federal Insecticide,

Fungicide, and Rodenticide Act or the science advisory board established by section 8 of the

Environmental Research, Development, and Demonstration 25 Act of 1978 (42 U.S.C. 4365),

the Administrator shall implement the program.

(3) SUBSTANCES.—In carrying out the screening program described in paragraph (1), the

Administrator—

(A) shall provide for the testing of all pesticide chemicals; and

(B) may provide for the testing of any other substance that may have an effect that is

cumulative to an effect of a pesticide chemical if the Administrator determines that a

substantial population may be exposed to such substance.

(4) EXEMPTION.—Notwithstanding paragraph (3), the Administrator may, by order, exempt

from the requirements of this section a biologic substance or other substance if the

Administrator determines that the substance is anticipated not to produce any effect in humans

similar to an effect produced by a naturally occurring estrogen.

(5) COLLECTION OF INFORMATION.—

(A) IN GENERAL.—The Administrator shall issue an order to a registrant of a substance for

which testing is required under this subsection, or to a person who manufactures or imports a

substance for which testing is required under this subsection, to conduct testing in accordance

with the screening program described in paragraph (1), and submit information obtained from

the testing to the Administrator, within a reasonable time period that the Administrator

determines is sufficient for the generation of the information.

(B) PROCEDURES.—To the extent practicable the Administrator shall minimize duplicative

testing of the same substance for the same endocrine effect, develop, as appropriate,

procedures for fair and equitable sharing of test costs, and develop, as necessary, procedures

for handling of confidential business information.

(C) FAILURE OF REGISTRANTS TO SUBMIT INFORMATION.—

(i) SUSPENSION.— If a registrant of a substance referred to in paragraph (3)(A) fails to

comply with an order under subparagraph (A) of this paragraph, the Administrator shall issue a

notice of intent to suspend the sale or distribution of the substance by the registrant. Any

suspension proposed under this paragraph shall become final at the end of the 30-day period

beginning on the date that the registrant receives the notice of intent to suspend, unless during

that period a person adversely affected by the notice requests a hearing or the Administrator

determines that the registrant has complied fully with this paragraph.

(ii) HEARING.— If a person requests a hearing under clause (i), the hearing shall be

conducted in accordance with section 554 of title 5, United States Code. The only matter for

resolution at the hearing shall be whether the registrant has failed to comply with an order

under subparagraph (A) of this paragraph. A decision by the Administrator after completion of

a hearing shall be considered to be a final agency action.

(iii) TERMINATION OF SUSPENSIONS.—The Administrator shall terminate a suspension

under this subparagraph issued with respect to a registrant if the Administrator determines that

the registrant has complied fully with this paragraph.

(D) NONCOMPLIANCE BY OTHER PERSONS.—Any person (other than a registrant) who

fails to comply with an order under subparagraph (A) shall be liable for the same penalties and

sanctions as are provided under section 16 of the Toxic Substances Control Act (15 U.S.C.

2601 and following) in the case of a violation referred to in that section. Such penalties and

sanctions shall be assessed and imposed in the same manner as provided in such section 16.

(6) AGENCY ACTION.—In the case of any substance that is found, as a result of testing and

evaluation under this section, to have an endocrine effect on humans, the Administrator shall,

as appropriate, take action under such statutory authority as is available to the Administrator,

including consideration under other sections of this Act, as is necessary to ensure the

protection of public health.

(7) REPORT TO CONGRESS.—Not later than 4 years after the date of enactment of this

section, the Administrator shall prepare and submit to Congress a report containing—

(A) the findings of the Administrator resulting from the screening program described in

paragraph (1);

(B) recommendations for further testing needed to evaluate the impact on human health of the

substances tested under the screening program; and

(C) recommendations for any further actions (including any action described in paragraph (6))

that the Administrator determines are appropriate based on the findings.

(q) SCHEDULE FOR REVIEW.—

(1) IN GENERAL.—The Administrator shall review tolerances and exemptions for pesticide

chemical residues in effect on the day before the date of the enactment of the Food Quality

Protection Act of 1996, as expeditiously as practicable, assuring that—

(A) 33 percent of such tolerances and exemptions are reviewed within 3 years of the date of

enactment of such Act;

(B) 66 percent of such tolerances and exemptions are reviewed within 6 years of the date of

enactment of such Act; and

(C) 100 percent of such tolerances and exemptions are reviewed within 10 years of the date of

enactment of such Act.

In conducting a review of a tolerance or exemption, the Administrator shall determine whether

the tolerance or exemption meets the requirements of subsections 26 (b)(2) or (c)(2) and shall,

by the deadline for the review of the tolerance or exemption, issue a regulation under

subsection (d)(4) or (e)(1) to modify or revoke the tolerance or exemption if the tolerance or

exemption does not meet such requirements.

(2) PRIORITIES.—In determining priorities for reviewing tolerances and exemptions under

paragraph (1), the Administrator shall give priority to the review of the tolerances or

exemptions that appear to pose the greatest risk to public health.

(3) PUBLICATION OF SCHEDULE.—Not later than 12 months after the date of the enactment

of the Food Quality Protection Act of 1996, the Administrator shall publish a schedule for

review of tolerances and exemptions established prior to the date of the enactment of the Food

Quality Protection Act of 1996. The determination of priorities for the review of tolerances and

exemptions pursuant to this subsection is not a rulemaking and shall not be subject to judicial

review, except that failure to take final action pursuant to the schedule established by this

paragraph shall be subject to judicial review.

(r) TEMPORARY TOLERANCE OR EXEMPTION.—The Administrator may, upon the request

of any person who has obtained an experimental permit for a pesticide chemical under the

Federal Insecticide, Fungicide, and Rodenticide Act or upon the Administrator’s own initiative,

establish a temporary tolerance or exemption for the pesticide chemical residue for the uses

covered by the permit. Subsections (b)(2), (c)(2), (d), and (e) shall apply to actions taken under

this subsection.

(s) SAVINGS CLAUSE.—Nothing in this section shall be construed to amend or modify the

provisions of the Toxic Substances Control Act or the Federal Insecticide, Fungicide, and

Rodenticide Act.

FOOD ADDITIVES

Unsafe Food Additives

SEC. 409. [21 U.S.C. 348] (a) A food additive shall, with respect to any particular use or

intended use of such additives, be deemed to be unsafe for the purposes of the application of

clause (2)(C) of section 402(a), unless—

(1) it and its use or intended use conform to the terms of an exemption which is in effect

pursuant to subsection (j) of this section;

(2) there is in effect, and it and its use or intended use are in conformity with, a regulation

issued under this section prescribing the conditions under which such additive may be safely

used; or

(3) in the case of a food additive as defined in this Act that is a food contact substance, there

is—

(A) in effect, and such substance and the use of such substance are in conformity with, a

regulation issued under this section prescribing the conditions under which such additive may

be safely used; or

(B) a notification submitted under subsection (h) that is effective.

While such a regulation relating to a food additive, or such a notification under subsection (h)(1)

relating to a food additive that is a food contact substance, is in effect, and has not been

revoked pursuant to subsection (i), a food shall not, by reason of bearing or containing such a

food additive in accordance with the regulation or notification, be considered adulterated under

section 402(a)(1).

Petition To Establish Safety

(b)(1) Any person may, with respect to any intended use of a food additive, file with the

Secretary a petition proposing the issuance of a regulation prescribing the conditions under

which such additive may be safely used.

(2) Such petition shall, in addition to any explanatory or supporting data, contain—

(A) the name and all pertinent information concerning such food additive, including, where

available, its chemical identity and composition;

(B) a statement of the conditions of the proposed use of such additive, including all directions,

recommendations, and suggestions proposed for the use of such additive, and including

specimens of its proposed labeling;

(C) all relevant data bearing on the physical or other technical effect such additive is intended

to produce, and the quantity of such additive required to produce such effect;

(D) a description of practicable methods for determining the quantity of such additive in or on

food, and any substance formed in or on food, because of its use; and

(E) full reports of investigations made with respect to the safety for use of such additive,

including full information as to the methods and controls used in conducting such

investigations.

(3) Upon request of the Secretary, the petitioner shall furnish (or, if the petitioner is not the

manufacturer of such additive, the petitioner shall have the manufacturer of such additive

furnish, without disclosure to the petitioner), a full description of the methods used in, and the

facilities and controls used for, the production of such additive.

(4) Upon request of the Secretary, the petitioner shall furnish samples of the food additive

involved, or articles used as components thereof, and of the food in or on which the additive is

proposed to be used.

(5) Notice of the regulation proposed by the petitioner shall be published in general terms by

the Secretary within thirty days after filing.

Action on the Petition

(c)(1) The Secretary shall—

(A) by order establish a regulation (whether or not in accord with that proposed by the

petitioner) prescribing, with respect to one or more proposed uses of the food additive involved,

the conditions under which such additive may be safely used (including, but not limited to,

specifications as to the particular food or classes of food in or on which such additive may be

used, the maximum quantity which may be used or permitted to remain in or on such food, the

manner in which such additive may be added to or used in or on such food, and any directions

or other labeling or packaging requirements for such additive deemed necessary by him to

assure the safety of such use), and shall notify the petitioner of such order and the reasons for

such action; or

(B) by order deny the petition, and shall notify the petitioner of such order and of the reasons

for such action.

(2) The order required by paragraph (1) (A) or (B) of this subsection shall be issued within

ninety days after the date of filing of the petition, except that the Secretary may (prior to such

ninetieth day), by written notice to the petitioner, extend such ninety day period to such time

(not more than one hundred and eighty days after the date of filing of the petition) as the

Secretary deems necessary to enable him to study and investigate the petition.

(3) No such regulation shall issue if a fair evaluation of the data before the Secretary—

(A) fails to establish that the proposed use of the food additive, under the conditions of use to

be specified in the regulation, will be safe: Provided, That no additive shall be deemed to be

safe if it is found to induce cancer when ingested by man or animal, or if it is found, after tests

which are appropriate for the evaluation of the safety of food additives, to induce cancer in

man or animal, except that this proviso shall not apply with respect to the use of a substance

as an ingredient of feed for animals which are raised for food production, if the Secretary finds

(i) that, under the conditions of use and feeding specified in proposed labeling and reasonably

certain to be followed in practice, such additive will not adversely affect the animals for which

such feed is intended, and (ii) that no residue of the additive will be found (by methods of

examination prescribed or approved by the Secretary by regulations, which regulations shall

not be subject to subsections (f) and (g)) in any edible portion of such animal after slaughter or

in any food yielded by or derived from the living animal; or

(B) shows that the proposed use of the additive would promote deception of the consumer in

violation of this Act or would otherwise result in adulteration or in misbranding of food within

the meaning of this Act.

(4) If, in the judgment of the Secretary, based upon a fair evaluation of the data before him, a

tolerance limitation is required in order to assure that the proposed use of an additive will be

safe, the Secretary—

(A) shall not fix such tolerance limitation at a level higher than he finds to be reasonably

required to accomplish the physical or other technical effect for which such additive is intended;

and

(B) shall not establish a regulation for such proposed use if he finds upon a fair evaluation of

the data before him that such data do not establish that such use would accomplish the

intended physical or other technical effect.

(5) In determining, for the purposes of this section, whether a proposed use of a food additive

is safe, the Secretary shall consider among other relevant factors—

(A) the probable consumption of the additive and of any substance formed in or on food

because of the use of the additive;

(B) the cumulative effect of such additive in the diet of man or animals, taking into account any

chemically or pharmacologically related substance or substances in such diet; and

(C) safety factors which in the opinion of experts qualified by scientific training and experience

to evaluate the safety of food additives are generally recognized as appropriate for the use of

animal experimentation data.

Regulation Issued on Secretary's Initiative

(d) The Secretary may at any time, upon his own initiative, propose the issuance of a

regulation prescribing, with respect to any particular use of a food additive, the conditions

under which such additive may be safely used, and the reasons therefor. After the thirtieth day

following publication of such a proposal, the Secretary may by order establish a regulation

based upon the proposal.

Publication and Effective Date of Orders

(e) Any order, including any regulation established by such order, issued under subsection (c)

or (d) of this section, shall be published and shall be effective upon publication, but the

Secretary may stay such effectiveness if, after issuance of such order, a hearing is sought with

respect to such order pursuant to subsection (f).

Objections and Public Hearing

(f)(1) Within thirty days after publication of an order made pursuant to subsection (c) or (d) of

this section, any person adversely affected by such an order may file objections thereto with

the Secretary, specifying with particularity the provisions of the order deemed objectionable,

stating reasonable grounds therefor, and requesting a public hearing upon such objections.

The Secretary shall, after due notice, as promptly as possible hold such public hearing for the

purpose of receiving evidence relevant and material to the issues raised by such objections.

As soon as practicable after completion of the hearing, the Secretary shall by order act upon

such objections and make such order public.

(2) Such order shall be based upon a fair evaluation of the entire record at such hearing, and

shall include a statement setting forth in detail the findings and conclusions upon which the

order is based.

(3) The Secretary shall specify in the order the date on which it shall take effect, except that it

shall not be made to take effect prior to the ninetieth day after its publication, unless the

Secretary finds that emergency conditions exist necessitating an earlier effective date, in

which event the Secretary shall specify in the order his findings as to such conditions.

Judicial Review

(g)(1) In a case of actual controversy as to the validity of any order issued under subsection (f),

including any order thereunder with respect to amendment or repeal of a regulation issued

under this section, any person who will be adversely affected by such order may obtain judicial

review by filing in the United States Court of Appeals for the circuit wherein such person

resides or has his principal place of business, or in the United States Court of Appeals for the

District of Columbia Circuit, within sixty days after the entry of such order, a petition praying

that the order be set aside in whole or in part.

(2) A copy of such petition shall be forthwith transmitted by the clerk of the court to the

Secretary, or any officer designated by him for that purpose, and thereupon the Secretary shall

file in the court the record of the proceedings on which he based his order, as provided in

section 2112 of title 28, United States Code. Upon the filing of such petition the court shall

have jurisdiction, which upon the filing of the record with it shall be exclusive, to affirm or set

aside the order complained of in whole or in part. Until the filing of the record the Secretary

may modify or set aside his order. The findings of the Secretary with respect to questions of

fact shall be sustained if based upon a fair evaluation of the entire record at such hearing.

(3) The court, on such judicial review, shall not sustain the order of the Secretary if he failed to

comply with any requirement imposed on him by subsection (f)(2) of this section.

(4) If application is made to the court for leave to adduce additional evidence, the court may

order such additional evidence to be taken before the Secretary and to be adduced upon the

hearing in such manner and upon such terms and conditions as to the court may seem proper,

if such evidence is material and there were reasonable grounds for failure to adduce such

evidence in the proceedings below. The Secretary may modify his findings as to the facts and

order by reason of the additional evidence so taken, and shall file with the court such modified

findings and order.

(5) The judgment of the court affirming or setting aside, in whole or in part, any order under this

section shall be final, subject to review by the Supreme Court of the United States upon

certiorari or certification as provided in section 1254 of title 28 of the United States Code. The

commencement of proceedings under this section shall not, unless specifically ordered by the

court to the contrary, operate as a stay of an order.

Notification Relating to a Food Contact Substance

(h)(1) Subject to such regulations as may be promulgated under paragraph (3), a

manufacturer or supplier of a food contact substance may, at least 120 days prior to the

introduction or delivery for introduction into interstate commerce of the food contact substance,

notify the Secretary of the identity and intended use of the food contact substance, and of the

determination of the manufacturer or supplier that the intended use of such food contact

substance is safe under the standard described in subsection (c)(3)(A). The notification shall

contain the information that forms the basis of the determination and all information required to

be submitted by regulations promulgated by the Secretary.

(2)(A) A notification submitted under paragraph (1) shall become effective 120 days after the

date of receipt by the Secretary and the food contact substance may be introduced or

delivered for introduction into interstate commerce, unless the Secretary makes a

determination within the 120-day period that, based on the data and information before the

Secretary, such use of the food contact substance has not been shown to be safe under the

standard described in subsection (c)(3)(A), and informs the manufacturer or supplier of such

determination.

(B) A decision by the Secretary to object to a notification shall constitute final agency action

subject to judicial review.

(C) In this paragraph, the term ‘‘food contact substance’’ means the substance that is the

subject of a notification submitted under paragraph (1), and does not include a similar or

identical substance manufactured or prepared by a person other than the manufacturer

identified in the notification.

(3)(A) The process in this subsection shall be utilized for authorizing the marketing of a food

contact substance except where the Secretary determines that submission and review of a

petition under subsection (b) is necessary to provide adequate assurance of safety, or where

the Secretary and any manufacturer or supplier agree that such manufacturer or supplier may

submit a petition under subsection (b).

(B) The Secretary is authorized to promulgate regulations to identify the circumstances in

which a petition shall be filed under subsection (b), and shall consider criteria such as the

probable consumption of such food contact substance and potential toxicity of the food contact

substance in determining the circumstances in which a petition shall be filed under subsection

(b).

(4) The Secretary shall keep confidential any information provided in a notification under

paragraph (1) for 120 days after receipt by the Secretary of the notification. After the expiration

of such 120 days, the information shall be available to any interested party except for any

matter in the notification that is a trade secret or confidential commercial information.

(5)(A)(i) Except as provided in clause (ii), the notification program established under this

subsection shall not operate in any fiscal year unless—

(I) an appropriation equal to or exceeding the applicable amount under clause (iv) is made for

such fiscal year for carrying out such program in such fiscal year; and

(II) the Secretary certifies that the amount appropriated for such fiscal year for the Center for

Food Safety and Applied Nutrition of the Food and Drug Administration (exclusive of the

appropriation referred to in subclause (I)) equals or exceeds the amount appropriated for the

Center for fiscal year 1997, excluding any amount appropriated for new programs.

(ii) The Secretary shall, not later than April 1, 1999, begin accepting and reviewing notifications

submitted under the notification program established under this subsection if—

(I) an appropriation equal to or exceeding the applicable amount under clause (iii) is made for

the last six months of fiscal year 1999 for carrying out such program during such period; and

(II) the Secretary certifies that the amount appropriated for such period for the Center for Food

Safety and Applied Nutrition of the Food and Drug Administration (exclusive of the

appropriation referred to in subclause (I)) equals or exceeds an amount equivalent to one-half

the amount appropriated for the Center for fiscal year 1997, excluding any amount

appropriated for new programs.

(iii) For the last six months of fiscal year 1999, the applicable amount under this clause is

$1,500,000, or the amount specified in the budget request of the President for the six-month

period involved for carrying out the notification program in fiscal year 1999, whichever is less.

(iv) For fiscal year 2000 and subsequent fiscal years, the applicable amount under this clause

is $3,000,000, or the amount specified in the budget request of the President for the fiscal year

involved for carrying out the notification program under this subsection, whichever is less.

(B) For purposes of carrying out the notification program under this subsection, there are

authorized to be appropriated such sums as may be necessary for each of the fiscal years

1999 through fiscal year 2003, except that such authorization of appropriations is not effective

for a fiscal year for any amount that is less than the applicable amount under clause (iii) or (iv)

of subparagraph (A), whichever is applicable.

(C) Not later than April 1 of fiscal year 1998 and February 1 of each subsequent fiscal year, the

Secretary shall submit a report to the Committees on Appropriations of the House of

Representatives and the Senate, the Committee on Commerce of the House of

Representatives, and the Committee on Labor and Human Resources of the Senate that

provides an estimate of the Secretary of the costs of carrying out the notification program

established under this subsection for the next fiscal year.

(6) In this section, the term ‘‘food contact substance’’ means any substance intended for use

as a component of materials used in manufacturing, packing, packaging, transporting, or

holding food if such use is not intended to have any technical effect in such food.

Amendment or Repeal of Regulations

(i) The Secretary shall by regulation prescribe the procedure by which regulations under the

foregoing provisions of this section may be amended or repealed, and such procedure shall

conform to the procedure provided in this section for the promulgation of such regulations. The

Secretary shall by regulation prescribe the procedure by which the Secretary may deem a

notification under subsection (h) to no longer be effective.

Exemptions for Investigational Use

(j) Without regard to subsections (b) to (i), inclusive, of this section, the Secretary shall by

regulation provide for exempting from the requirements of this section any food additive, and

any food bearing or containing such additive, intended solely for investigational use by

qualified experts when in his opinion such exemption is consistent with the public health.

BOTTLED DRINKING WATER STANDARDS

SEC. 410. [21 U.S.C. 349] (a) Except as provided in subsection (b), whenever the

Administrator of the Environmental Protection Agency prescribes interim or revised national

primary drinking water regulations under section 1412 of the Public Health Service Act, the

Secretary shall consult with the Administrator and within 180 days after the promulgation of

such drinking water regulations either promulgate amendments to regulations under this

chapter applicable to bottled drinking water or publish in the Federal Register his reasons for

not making such amendments.

(b)(1) Not later than 180 days before the effective date of a national primary drinking water

regulation promulgated by the Administrator of the Environmental Protection Agency for a

contaminant under section 1412 of the Safe Drinking Water Act (42 U.S.C. 300g–1), the

Secretary shall promulgate a standard of quality regulation under this subsection for that

contaminant in bottled water or make a finding that such a regulation is not necessary to

protect the public health because the contaminant is contained in water in public water

systems (as defined under section 1401(4) of such Act (42 U.S.C. 300f(4))) but not in water

used for bottled drinking water. The effective date for any such standard of quality regulation

shall be the same as the effective date for such national primary drinking water regulation,

except for any standard of quality of regulation promulgated by the Secretary before the date

of enactment of the Safe Drinking Water Act Amendments of 1996 for which (as of such date

of enactment) an effective date had not been established. In the case of a standard of quality

regulation to which such exception applies, the Secretary shall promulgate monitoring

requirements for the contaminants covered by the regulation not later than 2 years after such

date of enactment.

(2) A regulation issued by the Secretary as provided in this subsection shall include any

monitoring requirements that the Secretary determines appropriate for bottled water.

(3) A regulation issued by the Secretary as provided in this subsection shall require the

following:

(A) In the case of contaminants for which a maximum contaminant level is established in a

national primary drinking water regulation under section 1412 of the Safe Drinking Water Act

(42 U.S.C. 300g–1), the regulation under this subsection shall establish a maximum

contaminant level for the contaminant in bottled water which is no less stringent than the

maximum contaminant level provided in the national primary drinking water regulation.

(B) In the case of contaminants for which a treatment technique is established in a national

primary drinking water regulation under section 1412 of the Safe Drinking Water Act (42 U.S.C.

300g–1), the regulation under this subsection shall require that bottled water be subject to

requirements no less protective of the public health than those applicable to water provided by

public water systems using the treatment technique required by the national primary drinking

water regulation.

(4)(A) If the Secretary does not promulgate a regulation under this subsection within the period

described in paragraph (1), the national primary drinking water regulation referred to in

paragraph (1) shall be considered, as of the date on which the Secretary is required to

establish a regulation under paragraph (1), as the regulation applicable under this subsection

to bottled water.

(B) In the case of a national primary drinking water regulation that pursuant to subparagraph

(A) is considered to be a standard of quality regulation, the Secretary shall, not later than the

applicable date referred to in such subparagraph, publish in the Federal Register a notice—

(i) specifying the contents of such regulation, including monitoring requirements; and

(ii) providing that for purposes of this paragraph the effective date for such regulation is the

same as the effective date for the regulation for purposes of the Safe Drinking Water Act (or, if

the exception under paragraph (1) applies to the regulation, that the effective date for the

regulation is not later than 2 years and 180 days after the date of enactment of the Safe

Drinking Water Act Amendments of 1996).

VITAMINS AND MINERALS

SEC. 411. [21 U.S.C. 350] (a)(1) Except as provided in paragraph (2)—

(A) the Secretary may not establish, under section 201(n), 401, or 403, maximum limits on the

potency of any synthetic or natural vitamin or mineral within a food to which this section

applies;

(B) the Secretary may not classify any natural or synthetic vitamin or mineral (or combination

thereof) as a drug solely because it exceeds the level of potency which the Secretary

determines is nutritionally rational or useful;

(C) the Secretary may not limit, under section 201(n), 401, or 403, the combination or number

of any synthetic or natural—

(i) vitamin,

(ii) mineral, or

(iii) other ingredient of food,

within a food to which this section applies.

(2) Paragraph (1) shall not apply in the case of a vitamin, mineral, other ingredient of food, or

food, which is represented for use by individuals in the treatment or management of specific

diseases or disorders, by children, or by pregnant or lactating women. For purposes of this

subparagraph 27 , the term "children" means individuals who are under the age of twelve

years.

(b)(1) A food to which this section applies shall not be deemed under section 403 to be

misbranded solely because its label bears, in accordance with section 403(i)(2), all the

ingredients in the food or its advertising contains references to ingredients in the food which

are not vitamins or minerals.

(2) The labeling for any food to which this section applies may not list its ingredients which are

not dietary supplement ingredients described in section 201(ff) (i) except as a part of a list of all

the ingredients of such food, and (ii) unless such ingredients are listed in accordance with

applicable regulations under section 403. To the extent that compliance with clause (i) of this

subparagraph is impracticable or results in deception or unfair competition, exemptions shall

be established by regulations promulgated by the Secretary.

(c)(1) For purposes of this section, the term ‘‘food to which this section applies’’ means a food

for humans which is a food for special dietary use—

(A) which is or contains any natural or synthetic vitamin or mineral, and

(B) which—

(i) is intended for ingestion in tablet, capsule, powder, softgel, gelcap, or liquid form, or

(ii) if not intended for ingestion in such a form, is not represented as conventional food and is

not represented for use as a sole item of a meal or of the diet.

(2) For purposes of paragraph (1)(B)(i), a food shall be considered as intended for ingestion in

liquid form only if it is formulated in a fluid carrier and it is intended for ingestion in daily

quantities measured in drops or similar small units of measure.

(3) For purposes of paragraph (1) and of section 403 (j) insofar as that section is applicable to

food to which this section applies, the term ‘‘special dietary use’’ as applied to food used by

man means a particular use for which a food purports or is represented to be used, including

but not limited to the following:

(A) Supplying a special dietary need that exists by reason of a physical, physiological,

pathological, or other condition, including but not limited to the condition of disease,

convalescence, pregnancy, lactation, infancy, allergic hypersensitivity to food, underweight,

overweight, or the need to control the intake of sodium.

(B) Supplying a vitamin, mineral, or other ingredient for use by man to supplement his diet by

increasing the total dietary intake.

(C) Supplying a special dietary need by reason of being a food for use as the sole item of the

diet.

REQUIREMENTS FOR INFANT FORMULAS

SEC. 412. [21 U.S.C. 350a] (a) An infant formula, including an infant formula powder, shall be

deemed to be adulterated if—

(1) such infant formula does not provide nutrients as required by subsection (i),

(2) such infant formula does not meet the quality factor requirements prescribed by the

Secretary under subsection (b)(1), or

(3) the processing of such infant formula is not in compliance with the good manufacturing

practices and the quality control procedures prescribed by the Secretary under subsection

(b)(2).

(b)(1) The Secretary shall by regulation establish requirements for quality factors for infant

formulas to the extent possible consistent with current scientific knowledge, including quality

factor requirements for the nutrients required by subsection (i).

(2)(A) The Secretary shall by regulation establish good manufacturing practices for infant

formulas, including quality control procedures that the Secretary determines are necessary to

assure that an infant formula provides nutrients in accordance with this subsection and

subsection (i) and is manufactured in a manner designed to prevent adulteration of the infant

formula.

(B) The good manufacturing practices and quality control procedures prescribed by the

Secretary under subparagraph (A) shall include requirements for—

(i) the testing, in accordance with paragraph (3) and by the manufacturer of an infant formula

or an agent of such manufacturer, of each batch of infant formula for each nutrient required by

subsection (i) before the distribution of such batch,

(ii) regularly scheduled testing, by the manufacturer of an infant formula or an agent of such

manufacturer, of samples of infant formulas during the shelf life of such formulas to ensure that

such formulas are in compliance with this section,

(iii) in-process controls including, where necessary, testing required by good manufacturing

practices designed to prevent adulteration of each batch of infant formula, and

(iv) the conduct by the manufacturer of an infant formula or an agent of such manufacturer of

regularly scheduled audits to determine that such manufacturer has complied with the

regulations prescribed under subparagraph (A).

In prescribing requirements for audits under clause (iv), the Secretary shall provide that such

audits be conducted by appropriately trained individuals who do not have any direct

responsibility for the manufacture or production of infant formula.

(3)(A) At the final product stage, each batch of infant formula shall be tested for vitamin A,

vitamin B1, vitamin C, and vitamin E to ensure that such infant formula is in compliance with

the requirements of this subsection and subsection (i) relating to such vitamins.

(B) Each nutrient premix used in the manufacture of an infant formula shall be tested for each

relied upon nutrient required by subsection (i) which is contained in such premix to ensure that

such premix is in compliance with its specifications or certifications by a premix supplier.

(C) During the manufacturing process or at the final product stage and before distribution of an

infant formula, an infant formula shall be tested for all nutrients required to be included in such

formula by subsection (i) for which testing has not been conducted pursuant to subparagraph

(A) or (B). Testing under this subparagraph shall be conducted to—

(i) ensure that each batch of such infant formula is in compliance with the requirements of

subsection (i) relating to such nutrients, and

(ii) confirm that nutrients contained in any nutrient premix used in such infant formula are

present in each batch of such infant formula in the proper concentration.

(D) If the Secretary adds a nutrient to the list of nutrients in the table in subsection (i), the

Secretary shall by regulation require that the manufacturer of an infant formula test each batch

of such formula for such new nutrient in accordance with subparagraph (A), (B), or (C).

(E) For purposes of this paragraph, the term ‘‘final product stage’’ means the point in the

manufacturing process, before distribution of an infant formula, at which an infant formula is

homogenous and is not subject to further degradation.

(4)(A) The Secretary shall by regulation establish requirements respecting the retention of

records. Such requirements shall provide for—

(i) the retention of all records necessary to demonstrate compliance with the good

manufacturing practices and quality control procedures prescribed by the Secretary under

paragraph (2), including records containing the results of all testing required under paragraph

(2)(B),

(ii) the retention of all certifications or guarantees of analysis by premix suppliers,

(iii) the retention by a premix supplier of all records necessary to confirm the accuracy of all

premix certifications and guarantees of analysis,

(iv) the retention of—

(I) all records pertaining to the microbiological quality and purity of raw materials used in infant

formula powder and in finished infant formula, and

(II) all records pertaining to food packaging materials which show that such materials do not

cause an infant formula to be adulterated within the meaning of section 402(a)(2)(C),

(v) the retention of all records of the results of regularly scheduled audits conducted pursuant

to the requirements prescribed by the Secretary under paragraph (2)(B)(iv), and

(vi) the retention of all complaints and the maintenance of files with respect to, and the review

of, complaints concerning infant formulas which may reveal the possible existence of a hazard

to health.

(B)(i) Records required under subparagraph (A) with respect to an infant formula shall be

retained for at least one year after the expiration of the shelf life of such infant formula. Except

as provided in clause (ii), such records shall be made available to the Secretary for review and

duplication upon request of the Secretary.

(ii) A manufacturer need only provide written assurances to the Secretary that the regularly

scheduled audits required by paragraph (2)(B)(iv) are being conducted by the manufacturer,

and need not make available to the Secretary the actual written reports of such audits.

(c)(1) No person shall introduce or deliver for introduction into interstate commerce any new

infant formula unless—

(A) such person has, before introducing such new infant formula, or delivering such new infant

formula for introduction, into interstate commerce, registered with the Secretary the name of

such person, the place of business of such person, and all establishments at which such

person intends to manufacture such new infant formula, and

(B) such person has at least 90 days before marketing such new infant formula, made the

submission to the Secretary required by subsection (c)(1).

(2) For purposes of paragraph (1), the term ‘‘new infant formula’’ includes—

(A) an infant formula manufactured by a person which has not previously manufactured an

infant formula, and

(B) an infant formula manufactured by a person which has previously manufactured infant

formula and in which there is a major change, in processing or formulation, from a current or

any previous formulation produced by such manufacturer.

For purposes of this paragraph, the term "major change" has the meaning given to such term

in section 106.30(c)(2) of title 21, Code of Federal Regulations (as in effect on August 1, 1986),

and guidelines issued thereunder.

(d)(1) A person shall, with respect to any infant formula subject to subsection (c), make a

submission to the Secretary which shall include—

(A) the quantitative formulation of the infant formula,

(B) a description of any reformulation of the formula or change in processing of the infant

formula,

(C) assurances that the infant formula will not be marketed unless it meets the requirements of

subsections (b)(1) and (i), as demonstrated by the testing required under subsection (b)(3),

and

(D) assurances that the processing of the infant formula complies with subsection (b)(2).

(2) After the first production of an infant formula subject to subsection (c), and before the

introduction into interstate commerce of such formula, the manufacturer of such formula shall

submit to the Secretary, in such form as may be prescribed by the Secretary, a written

verification which summarizes test results and records demonstrating that such formula

complies with the requirements of subsections (b)(1), (b)(2)(A), (b)(2)(B)(i), (b)(2)(B)(iii),

(b)(3)(A), (b)(3)(C), and (i).

(3) If the manufacturer of an infant formula for commercial or charitable distribution for human

consumption determines that a change in the formulation of the formula or a change in the

processing of the formula may affect whether the formula is adulterated under subsection (a),

the manufacturer shall, before the first processing of such formula, make the submission to the

Secretary required by paragraph (1).

(e)(1) If the manufacturer of an infant formula has knowledge which reasonably supports the

conclusion that an infant formula which has been processed by the manufacturer and which

has left an establishment subject to the control of the manufacturer—

(A) may not provide the nutrients required by subsection (i), or

(B) may be otherwise adulterated or misbranded, the manufacturer shall promptly notify the

Secretary of such knowledge. If the Secretary determines that the infant formula presents a

risk to human health, the manufacturer shall immediately take all actions necessary to recall

shipments of such infant formula from all wholesale and retail establishments, consistent with

recall regulations and guidelines issued by the Secretary.

(2) For purposes of paragraph (1), the term ‘‘knowledge’’ as applied to a manufacturer means

(A) the actual knowledge that the manufacturer had, or (B) the knowledge which a reasonable

person would have had under like circumstances or which would have been obtained upon the

exercise of due care.

(f)(1) If a recall of infant formula is begun by a manufacturer, the recall shall be carried out in

accordance with such requirements as the Secretary shall prescribe under paragraph (2)

and—

(A) the Secretary shall, not later than the 15th day after the beginning of such recall and at

least once every 15 days thereafter until the recall is terminated, review the actions taken

under the recall to determine whether the recall meets the requirements prescribed under

paragraph (2), and

(B) the manufacturer shall, not later than the 14th day after the beginning of such recall and at

least once every 14 days thereafter until the recall is terminated, report to the Secretary the

actions taken to implement the recall.

(2) The Secretary shall by regulation prescribe the scope and extent of recalls of infant

formulas necessary and appropriate for the degree of risks to human health presented by the

formula subject to the recall.

(3) The Secretary shall by regulation require each manufacturer of an infant formula who

begins a recall of such formula because of a risk to human health to request each retail

establishment at which such formula is sold or available for sale to post at the point of

purchase of such formula a notice of such recall at such establishment for such time that the

Secretary determines necessary to inform the public of such recall.

(g)(1) Each manufacturer of an infant formula shall make and retain such records respecting

the distribution of the infant formula through any establishment owned or operated by such

manufacturer as may be necessary to effect and monitor recalls of the formula. Such records

shall be retained for at least one year after the expiration of the shelf life of the infant formula.

(2) To the extent that the Secretary determines that records are not being made or maintained

in accordance with paragraph (1), the Secretary may by regulation prescribe the records

required to be made under paragraph (1) and requirements respecting the retention of such

records under such paragraph. Such regulations shall take effect on such date as the

Secretary prescribes but not sooner than the 180th day after the date such regulations are

promulgated. Such regulations shall apply only with respect to distributions of infant formulas

made after such effective date.

(h)(1) Any infant formula which is represented and labeled for use by an infant—

(A) who has an inborn error of metabolism or a low birth weight, or

(B) who otherwise has an unusual medical or dietary problem,

is exempt from the requirements of subsections (a), (b), and (c). The manufacturer of an infant

formula exempt under this paragraph shall, in the case of the exempt formula, be required to

provide the notice required by subsection (e)(1) only with respect to adulteration or

misbranding described in subsection (e)(1)(B) and to comply with the regulations prescribed

by the Secretary under paragraph (2).

(2) The Secretary may by regulation establish terms and conditions for the exemption of an

infant formula from the requirements of subsections (a), (b), and (c). An exemption of an infant

formula under paragraph (1) may be withdrawn by the Secretary if such formula is not in

compliance with applicable terms and conditions prescribed under this paragraph.

(i)(1) An infant formula shall contain nutrients in accordance with the table set out in this

subsection or, if revised by the Secretary under paragraph (2), as so revised.

(2) The Secretary may by regulation—

(A) revise the list of nutrients in the table in this subsection, and

(B) revise the required level for any nutrient required by the table.

NUTRIENTS

Nutrient Minimum 1 Maximum 1

Protein (gm) 1.8 2 4.5.

Fat:

gm 3.3 6.0.

percent cal 30.0 54.0.

Essential fatty acids

(linoleate):

percent cal 2.7

mg 300.0

Vitamins:

A (IU) 250.0 (75 µg) 3 750.0 (225 µg) 3

D (IU) 40.0 100.0.

K (µg) 4.0

E (IU) 0.7 (with 0.7 IU/gm

linoleic acid).

C (ascorbic acid) (mg) 8.0

B1 (thiamine) (µg) 40.0

B2 (riboflavin) (µg) 60.0

B6 (pyridoxine) (µg) 35.0 (with 15 µg/gm of

protein in formula).

B12 (µg) 0.15

Niacin (µg) 250.0

Folic acid (µg) 4.0

Pantothenic acid (µg) 300.0

Biotin (µg) 1.5 4

Choline (mg) 7.0 4

Inositol (mg) 4.0 4

Minerals:

Calcium (mg) 50.0 5

Phosphorus (mg) 25.0 5

Magnesium (mg) 6.0

Iron (mg) 0.15

Iodine (µg) 5.0

Zinc (mg) 0.5

Copper (µg) 60.0

Manganese (µg) 5.0

Sodium (mg) 20.0 60.0.

Potassium (mg) 80.0 200.0.

Chloride (mg) 55.0 150.0.

__________________________________________________________________

1 Stated per 100 kilocalories.

2 The source of protein shall be at least nutritionally equivalent to casein.

3 Retinol equivalents.

4 Required to be included in this amount only in formulas which are not milk-based.

5 Calcium to phosphorus ratio must be no less than 1.1 nor more than 2.0.

NEW DIETARY INGREDIENTS

SEC. 413 . [21 U.S.C. 350b] (a) IN GENERAL.—A dietary supplement which contains a new

dietary ingredient shall be deemed adulterated under section 402(f) unless it meets one of the

following requirements:

(1) The dietary supplement contains only dietary ingredients which have been present in the

food supply as an article used for food in a form in which the food has not been chemically

altered.

(2) There is a history of use or other evidence of safety establishing that the dietary ingredient

when used under the conditions recommended or suggested in the labeling of the dietary

supplement will reasonably be expected to be safe and, at least 75 days before being

introduced or delivered for introduction into interstate commerce, the manufacturer or

distributor of the dietary ingredient or dietary supplement provides the Secretary with

information, including any citation to published articles, which is the basis on which the

manufacturer or distributor has concluded that a dietary supplement containing such dietary

ingredient will reasonably be expected to be safe.

The Secretary shall keep confidential any information provided under paragraph (2) for 90

days following its receipt. After the expiration of such 90 days, the Secretary shall place such

information on public display, except matters in the information which are trade secrets or

otherwise confidential, commercial information.

(b) PETITION.—Any person may file with the Secretary a petition proposing the issuance of an

order prescribing the conditions under which a new dietary ingredient under its intended

conditions of use will reasonably be expected to be safe. The Secretary shall make a decision

on such petition within 180 days of the date the petition is filed with the Secretary. For

purposes of chapter 7 of title 5, United States Code, the decision of the Secretary shall be

considered final agency action.

(c) DEFINITION.—For purposes of this section, the term ‘‘new dietary ingredient’’ means a

dietary ingredient that was not marketed in the United States before October 15, 1994 and

does not include any dietary ingredient which was marketed in the United States before

October 15, 1994.

SEC. 414.[21 USC 350c] MAINTENANCE AND INSPECTION OF RECORDS

(a) RECORDS INSPECTION. — If the Secretary has a reasonable belief that an article of food

is adulterated and presents a threat of serious adverse health consequences or death to

humans or animals, each person (excluding farms and restaurants) who manufactures,

processes, packs, distributes, receives, holds, or imports such article shall, at the request of an

officer or employee duly designated by the Secretary, permit such officer or employee, upon

presentation of appropriate credentials and a written notice to such person, at reasonable

times and within reasonable limits and in a reasonable manner, to have access to and copy all

records relating to such article that are needed to assist the Secretary in determining whether

the food is adulterated and presents a threat of serious adverse health consequences or death

to humans or animals. The requirement under the preceding sentence applies to all records

relating to the manufacture, processing, packing, distribution, receipt, holding, or importation of

such article maintained by or on behalf of such person in any format (including paper and

electronic formats) and at any location.

(b) REGULATIONS CONCERNING RECORDKEEPING.—The Secretary, in consultation and

coordination, as appropriate, with other Federal departments and agencies with

responsibilities for regulating food safety, may by regulation establish requirements regarding

the establishment and maintenance, for not longer than two years, of records by persons

(excluding farms and restaurants) who manufacture, process, pack, transport, distribute,

receive, hold, or import food, which records are needed by the Secretary for inspection to allow

the Secretary to identify the immediate previous sources and the immediate subsequent

recipients of food, including its packaging, in order to address credible threats of serious

adverse health consequences or death to humans or animals. The Secretary shall take into

account the size of a business in promulgating regulations under this section.

(c) Protection of Sensitive Information.—The Secretary shall take appropriate measures to

ensure that there are in effect effective procedures to prevent the unauthorized disclosure of

any trade secret or confidential information that is obtained by the Secretary pursuant to this

section.

(d) Limitations.—This section shall not be construed--

(1) to limit the authority of the Secretary to inspect records or to require establishment and

maintenance of records under any other provision of this Act;

(2) to authorize the Secretary to impose any requirements with respect to a food to the extent

that it is within the exclusive jurisdiction of the Secretary of Agriculture pursuant to the Federal

Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry Products Inspection Act (21 U.S.C.

451 et seq.), or the Egg Products Inspection Act (21 U.S.C. 1031 et seq.);

(3) to have any legal effect on section 552 of title 5, United States Code, or section 1905 of title

18, United States Code; or

(4) to extend to recipes for food, financial data, pricing data, personnel data, research data, or

sales data (other than shipment data regarding sales).

SEC. 415 . [21 USC 350d].REGISTRATION OF FOOD FACILITIES

(a) Registration.—

(1) Regulations.— In general.--The Secretary shall by regulation require that any facility

engaged in manufacturing, processing, packing, or holding food for consumption in the United

States be registered with the Secretary. To be registered--

(A) for a domestic facility, the owner, operator, or agent in charge of the facility shall submit a

registration to the Secretary; and

(B) for a foreign facility, the owner, operator, or agent in charge of the facility shall submit a

registration to the Secretary and shall include with the registration the name of the United

States agent for the facility.

(2) Registration.—An entity (referred to in this section as the `registrant') shall submit a

registration under paragraph (1) to the Secretary containing information necessary to notify the

Secretary of the name and address of each facility at which, and all trade names under which,

the registrant conducts business and, when determined necessary by the Secretary through

guidance, the general food category (as identified under section 170.3 of title 21, Code of

Federal Regulations) of any food manufactured, processed, packed, or held at such facility.

The registrant shall notify the Secretary in a timely manner of changes to such information.

(3) Notification.—Upon receipt of a completed registration described in paragraph (1), the

Secretary shall notify the registrant of the receipt of such registration and assign a registration

number to each registered facility.

(4) Records.—The Secretary shall compile and maintain an up-to-date list of facilities that are

registered under this section. Such list and any registration documents submitted pursuant to

this subsection shall not be subject to disclosure under section 552 of title 5, United States

Code. Information derived from such list or registration documents shall not be subject to

disclosure under section 552 of title 5, United States Code, to the extent that it discloses the

identity or location of a specific registered person.

(b) Facility.—For purposes of this section:

(1) The term `facility' includes any factory, warehouse, or establishment (including a factory,

warehouse, or establishment of an importer) that manufactures, processes, packs, or holds

food. Such term does not include farms; restaurants; other retail food establishments; nonprofit

food establishments in which food is prepared for or served directly to the consumer; or fishing

vessels (except such vessels engaged in processing as defined in section 123.3(k) of title 21,

Code of Federal Regulations).

(2) The term `domestic facility' means a facility located in any of the States or Territories.

(3)(A) The term `foreign facility' means a facility that manufacturers, processes, packs, or

holds food, but only if food from such facility is exported to the United States without further

processing or packaging outside the United States.

(B) A food may not be considered to have undergone further processing or packaging for

purposes of subparagraph (A) solely on the basis that labeling was added or that any similar

activity of a de minimis nature was carried out with respect to the food.

(c) Rule of Construction.—Nothing in this section shall be construed to authorize the Secretary

to require an application, review, or licensing process.

Sec. 416 [21 USC § 350e] SANITARY TRANSPORTATION PRACTICES

(a) Definitions. In this section:

(1) Bulk vehicle. The term "bulk vehicle" includes a tank truck, hopper truck, rail tank car,

hopper car, cargo tank, portable tank, freight container, or hopper bin, and any other vehicle in

which food is shipped in bulk, with the food coming into direct contact with the vehicle.

(2) Transportation. The term "transportation" means any movement in commerce by motor

vehicle or rail vehicle.

(b) Regulations. The Secretary shall by regulation require shippers, carriers by motor vehicle

or rail vehicle, receivers, and other persons engaged in the transportation of food to use

sanitary transportation practices prescribed by the Secretary to ensure that food is not

transported under conditions that may render the food adulterated.

(c) Contents. The regulations under subsection (b) shall--

(1) prescribe such practices as the Secretary determines to be appropriate relating to--

(A) sanitation;

(B) packaging, isolation, and other protective measures;

(C) limitations on the use of vehicles;

(D) information to be disclosed--

(i) to a carrier by a person arranging for the transport of food; and

(ii) to a manufacturer or other person that--

(I) arranges for the transportation of food by a carrier; or

(II) furnishes a tank vehicle or bulk vehicle for the transportation of food; and

(E) recordkeeping; and

(2) include--

(A) a list of nonfood products that the Secretary determines may, if shipped in a bulk vehicle,

render adulterated food that is subsequently transported in the same vehicle; and

(B) a list of nonfood products that the Secretary determines may, if shipped in a motor vehicle

or rail vehicle (other than a tank vehicle or bulk vehicle), render adulterated food that is

simultaneously or subsequently transported in the same vehicle.

(d) Waivers.

(1) In general. The Secretary may waive any requirement under this section, with respect to

any class of persons, vehicles, food, or nonfood products, if the Secretary determines that the

waiver--

(A) will not result in the transportation of food under conditions that would be unsafe for human

or animal health; and

(B) will not be contrary to the public interest.

(2) Publication. The Secretary shall publish in the Federal Register any waiver and the

reasons for the waiver.

(e) Preemption.

(1) In general. A requirement of a State or political subdivision of a State that concerns the

transportation of food is preempted if--

(A) complying with a requirement of the State or political subdivision and a requirement of this

section, or a regulation prescribed under this section, is not possible; or

(B) the requirement of the State or political subdivision as applied or enforced is an obstacle to

accomplishing and carrying out this section or a regulation prescribed under this section.

(2) Applicability. This subsection applies to transportation that occurs on or after the effective

date of the regulations promulgated under subsection (b).

(f) Assistance of other agencies. The Secretary of Transportation, the Secretary of Agriculture,

the Administrator of the Environmental Protection Agency, and the heads of other Federal

agencies, as appropriate, shall provide assistance on request, to the extent resources are

available, to the Secretary for the purposes of carrying out this section.

Footnotes: Chapter IV

1. See footnote for section 403(h)(3) regarding the stylistic use of a list consisting of "(a)",

"(b)", etc.

2. So in law. See section 3(i)(1) of Public Law 103–80. Probably should be "or".

3. Subparagraph (2) appears so as to reflect the probable intent of the Congress. Section 404

of Public Law 104–170 (110 Stat. 1514) had amendatory instructions whose probable intended

effect was to strike the existing subparagraph (2) and to insert a substitute subparagraph (2).

These included instructions to strike "(2)(A) if it bears'" and all that follows through "(3) if it

consists", but "(3) If it consists" was the language that actually appeared. (Previously, section

3(i) of Public Law 103–80 (107 Stat. 776) had amended subparagraph (3) by striking "if it" and

inserting "If it".)

4. So in law. Probably should be "subparagraph".

5. See footnote for paragraph (h)(3) regarding the stylistic use of a list consisting of "(a)",

"(b)", etc.

6. References are so in law. See section 10808(b)(3) of Public Law 107–171 (116 Stat. 530).

In order to be consistent with other cross-references within section 403 above, each reference

in section 403(h)(3) to a paragraph, subparagraph, clause, or subclause should be a reference

to a subparagraph, clause, subclause, or item, respectively. See, for example,

cross-references in paragraph (q) (relating to nutrition information) and paragraph (r) (relating

to nutrient levels and health claims).

Section 403 was enacted in 1938 and has organizational units and cross-references that are

not in accordance with modern practice. In modern practice, "(a)" is a subsection, "(1)" is a

paragraph, "(A)" is a subparagraph, "(i)" is a clause, "(I)" is a subclause, "(aa)" is an item, and

"(AA)" is a subitem. The references in section 403(h)(3) follow this practice.

In modern practice, all of the section 403 text would be considered an undesignated

subsection, and the list that begins after "A food shall be deemed to be misbranded—" would

consist of paragraphs (1), (2), etc.

In section 403, however, the original authors of the 1938 Act used a list consisting of (a), (b),

etc., and the authors referred to "(a)" as a paragraph, "(1)" as a subparagraph, "(A)" as a

clause, and "(i)" as a subclause. (Express references to organizational units below the "(i)"

level have been avoided.)

The original authors followed this approach in each section in this Act whose text was a list

consisting of (a), (b), etc. Such sections include sections 201, 301, 402, 403, 501, 502, 601,

and 602.

Some of these sections have numerous internal cross-references. Rather than conforming

each of these to the modern practice, the usual approach in making amendments to these

sections has been to follow the approach used by the original authors of the 1938 Act.

7. So in law. Probably should be followed by a comma.

8. Paragraph (o) was repealed by Public Law 106–554 (114 Stat. 2763A–73). Paragraph (p)

was struck by Public Law 104–124 (110 Stat. 882).

9. Public Law 101–535, which was enacted November 8, 1990.

10. 1 Section 403(t) was added by subsection (a)(2) of section 10806 of Public Law 107–171

(116 Stat. 526). Subsection (a)(1) of such section 10806 provides as follows:

(1) IN GENERAL.—Notwithstanding any other provision of law, for purposes of the Federal

Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.)—

(A) the term "catfish" may only be considered to be a common or usual name (or part thereof)

for fish classified within the family Ictaluridae; and

(B) only labeling or advertising for fish classified within that family may include the term

"catfish"

11. Section 403(u) was added by subsection (b)(2) of section 10806 of Public Law 107–171

(116 Stat. 527). Subsection (b)(1) of such section 10806 provides as follows:

(1) IN GENERAL.—Notwithstanding any other provision of law, for purposes of the Federal

Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.)—

(A) the term "ginseng" may only be considered to be a common or usual name (or part thereof)

for any herb or herbal ingredient derived from a plant classified within the genus Panax; and

(B) only labeling or advertising for herbs or herbal ingredients classified within that

genus may include the term ‘‘ginseng’’.

12. Paragraphs (w) and (x) were added by section 203(a) of Public Law 108–282. Section

203(d) provides as follows:

(d) EFFECTIVE DATE.—The amendments made by this section shall apply to any food that is

labeled on or after January 1, 2006.

13. Section 203(b) of Public Law 108–282 provides as follows:

(b) EFFECT ON OTHER AUTHORITY.—The amendments made by this section that require a

label or labeling for major food allergens do not alter the authority of the Secretary of Health

and Human Services under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.)

to require a label or labeling for other food allergens.

14. Several provisions of paragraph (w) contain cross-references to other provisions of the

paragraph, and also references to other provisions of this section (section 403). The

references to subsections, paragraphs, and subparagraphs probably should be references to

paragraphs, subparagraphs, and clauses, respectively. See footnote for paragraph (h)(3).

15. Public Law 108–282 contains several sections concerning food allergens that do not make

amendments to this Act (the Federal Food, Drug, and Cosmetic Act). Section 204 concerns a

report to congressional committees; section 205 concerns inspections; section 206 concerns

gluten labeling; section 207 concerns improvements in the collection and publication of data;

section 208 concerns research; section 209 concerns the Food Code; and section 210

concerns recommendations regarding responding to food-related allergic responses.

16. See footnote 1 to paragraph (w) regarding an effective date, and see footnote 2 to such

paragraph regarding the authority of the Secretary of Health and Human Services.

17. So in law. Probably should be "paragraph (g), (i), or (k)". See footnote 3 for paragraph (w).

18. Section 403A was enacted without a section heading. See section 6(a) of Public Law 101–

535 (104 Stat. 2362).

19. See the revolving fund provision in the appendix.

20. Section 4 of Public Law 81–459 (64 Stat. 20) amended section 15 of the Federal Trade

Commission Act (15 U.S.C. 55) by adding the following subsection:

"(f) For the purposes of this section and section 407 of the Federal Food, Drug, and Cosmetic

Act, as amended, the term 'oleomargarine' or 'margarine' includes—

"(1) all substances, mixtures, and compounds known as oleomargarine or margarine;

"(2) all substances, mixtures, and compounds which have a consistence similar to that of

butter and which contain any edible oils or fats other than milk fat if made in imitation

or semblance of butter."

In repealing section 2301 of the Internal Revenue Code (relating to the tax on oleomargarine)

Public Law 81–459 declared, in part: "The Congress hereby finds and declares that the sale,

or the serving in public eating places, of colored oleomargarine or colored margarine without

clear identification as such or which is otherwise adulterated or misbranded within the meaning

of the Federal Food, Drug, and Cosmetic Act depresses the market in interstate commerce for

butter and for oleomargarine or margarine clearly identified and neither adulterated nor

misbranded, and constitutes a burden on interstate commerce in such articles. Such burden

exists, irrespective of whether such oleomargarine or margarine originates from an interstate

source or from the State in which it is sold."

Section 6 of such Public Law states that "nothing in this Act shall be construed as authorizing

the possession, sale, or serving of colored oleomargarine or colored margarine in any State or

Territory in contravention of the laws of such State or Territory."

21. So in law. Probably should be "(except paragraphs (a) and (f))".

22. See footnote for section 406.

23. Section 501(d)(2) of division G of Public Law 108–199 (118 Stat. 422) provides as follows:

(2) TOLERANCE FEES.—Notwithstanding section 408(m)(1) of the Federal Food, Drug, and

Cosmetic Act (21 U.S.C. 346a(m)(1)), during the period beginning on October 1, 2003, and

ending on September 30, 2008, the Administrator of the Environmental Protection Agency

shall not collect any tolerance fees under that section.

24. Indentation is so in law. Beginning of sentence probably should be moved to left.

25. So in law. The word "Authorization" probably should appear after "Demonstration".

26. So in law. Probably should be "subsection".

27. So in law. Probably should be "paragraph".

CHAPTER V—DRUGS AND DEVICES SUBCHAPTER A—DRUGS AND DEVICES

ADULTERATED DRUGS AND DEVICES

SEC. 501. [21 U.S.C. 351] A drug or device shall be deemed to be adulterated— 1

(a)(1) If it consists in whole or in part of any filthy, putrid, or decomposed substance; or (2)(A) if

it has been prepared, packed, or held under insanitary conditions whereby it may have been

contaminated with filth, or whereby it may have been rendered injurious to health; or (B) if it is

a drug and the methods used in, or the facilities or controls used for, its manufacture,

processing, packing, or holding do not conform to or are not operated or administered in

conformity with current good manufacturing practice to assure that such drug meets the

requirements of this Act as to safety and has the identity and strength, and meets the quality

and purity characteristics, which it purports or is represented to possess; or (C) if it is a

compounded positron emission tomography drug and the methods used in, or the facilities and

controls used for, its compounding, processing, packing, or holding do not conform to or are

not operated or administered in conformity with the positron emission tomography

compounding standards and the official monographs of the United States Pharmacopoeia to

assure that such drug meets the requirements of this Act as to safety and has the identity and

strength, and meets the quality and purity characteristics, that it purports or is represented to

possess; or (3) if its container is composed, in whole or in part, of any poisonous or deleterious

substance which may render the contents injurious to health; or (4) if (A) it bears or contains,

for purposes of coloring only, a color additive which is unsafe within the meaning of section

721(a), or (B) it is a color additive the intended use of which in or on drugs or devices is for

purposes of coloring only and is unsafe within the meaning of section 721(a); or (5) if it is a

new animal drug which is unsafe within the meaning of section 512; or (6) if it is an animal feed

bearing or containing a new animal drug, and such animal feed is unsafe within the meaning of

section 512.

(b) If it purports to be or is represented as a drug the name of which is recognized in an official

compendium, and its strength differs from, or its quality or purity falls below, the standards set

forth in such compendium. Such determination as to strength, quality, or purity shall be made

in accordance with the tests or methods of assay set forth in such compendium, except that

whenever tests or methods of assay have not been prescribed in such compendium, or such

tests or methods of assay as are prescribed are, in the judgment of the Secretary, insufficient

for the making of such determination, the Secretary shall bring such fact to the attention of the

appropriate body charged with the revision of such compendium, and if such body fails within a

reasonable time to prescribe tests or methods of assay which, in the judgment of the Secretary,

are sufficient for purposes of this paragraph, then the Secretary shall promulgate regulations

prescribing appropriate tests or methods of assay in accordance with which such

determination as to strength, quality, or purity shall be made. No drug defined in an official

compendium shall be deemed to be adulterated under this paragraph because it differs from

the standard of strength, quality, or purity therefor set forth in such compendium, if its

difference in strength, quality, or purity from such standards is plainly stated on its label.

Whenever a drug is recognized in both the United States Pharmacopeia and the Homeopathic

Pharmacopeia of the United States it shall be subject to the requirements of the United States

Pharmacopeia unless it is labeled and offered for sale as a homeopathic drug, in which case it

shall be subject to the provisions of the Homeopathic Pharmacopeia of the United States and

not to those of the United States Pharmacopeia.

(c) If it is not subject to the provisions of paragraph (b) of this section and its strength differs

from, or its purity or quality falls below, that which it purports or is represented to possess.

(d) If it is a drug and any substance has been (1) mixed or packed therewith so as to reduce its

quality or strength or (2) substituted wholly or in part therefor.

(e)(1) If it is, or purports to be or is represented as, a device which is subject to a performance

standard established under section 514, unless such device is in all respects in conformity with

such standard.

(2) If it is declared to be, purports to be, or is represented as, a device that is in conformity with

any standard recognized under section 514(c) unless such device is in all respects in

conformity with such standard.

(f)(1) If it is a class III device—

(A)(i) which is required by a regulation promulgated under subsection (b) of section 515 to

have an approval under such section of an application for premarket approval and which is not

exempt from section 515 under section 520(g), and

(ii)(I) for which an application for premarket approval or a notice of completion of a product

development protocol was not filed with the Secretary within the ninety-day period beginning

on the date of the promulgation of such regulation, or

(II) for which such an application was filed and approval of the application has been denied,

suspended, or withdrawn, or such a notice was filed and has been declared not completed or

the approval of the device under the protocol has been withdrawn;

(B)(i) which was classified under section 513(f) into class III, which under section 515(a) is

required to have in effect an approved application for premarket approval, and which is not

exempt from section 515 under section 520(g), and

(ii) which has an application which has been suspended or is otherwise not in effect; or

(C) which was classified under section 520(l) into class III, which under such section is

required to have in effect an approved application under section 515, and which has an

application which has been suspended or is otherwise not in effect.

(2)(A) In the case of a device classified under section 513(f) into class III and intended solely

for investigational use, paragraph (1)(B) shall not apply with respect to such device during the

period ending on the ninetieth day after the date of the promulgation of the regulations

prescribing the procedures and conditions required by section 520(g)(2).

(B) In the case of a device subject to a regulation promulgated under subsection (b) of section

515, paragraph 2 (1) shall not apply with respect to such device during the period ending—

(i) on the last day of the thirtieth calendar month beginning after the month in which the

classification of the device in class III became effective under section 513, or

(ii) on the ninetieth day after the date of the promulgation of such regulation, whichever occurs

later.

(g) If it is a banned device.

(h) If it is a device and the methods used in, or the facilities or controls used for, its

manufacture, packing, storage, or installation are not in conformity with applicable

requirements under section 520(f)(1) or an applicable condition prescribed by an order under

section 520(f)(2).

(i) If it is a device for which an exemption has been granted under section 520(g) for

investigational use and the person who was granted such exemption or any investigator who

uses such device under such exemption fails to comply with a requirement prescribed by or

under such section.

MISBRANDED DRUGS AND DEVICES

SEC. 502. [21 U.S.C. 352] A drug or device shall be deemed to be misbranded 3

(a) False or misleading label. If its labeling is false or misleading in any particular. Health care

economic information provided to a formulary committee, or other similar entity, in the course

of the committee or the entity carrying out its responsibilities for the selection of drugs for

managed care or other similar organizations, shall not be considered to be false or misleading

under this paragraph if the health care economic information directly relates to an indication

approved under section 505 or under section 351(a) of the Public Health Service Act [42

USCS § 262(a)] for such drug and is based on competent and reliable scientific evidence. The

requirements set forth in section 505(a) or in section 351(a) of the Public Health Service Act

shall not apply to health care economic information provided to such a committee or entity in

accordance with this paragraph. Information that is relevant to the substantiation of the health

care economic information presented pursuant to this paragraph shall be made available to

the Secretary upon request. In this paragraph, the term "health care economic information"

means any analysis that identifies, measures, or compares the economic consequences,

including the costs of the represented health outcomes, of the use of a drug to the use of

another drug, to another health care intervention, or to no intervention.

(b) Package form; contents of label. If in package form unless it bears a label containing (1) the

name and place of business of the manufacturer, packer, or distributor; and (2) an accurate

statement of the quantity of the contents in terms of weight, measure, or numerical count:

Provided, That under clause (2) of this paragraph reasonable variations shall be permitted,

and exemptions as to small packages shall be established, by regulations prescribed by the

Secretary.

(c) Prominence of information on label. If any word, statement, or other information required by

or under authority of this Act to appear on the label or labeling is not prominently placed

thereon with such conspicuousness (as compared with other words, statements, designs, or

devices, in the labeling) and in such terms as to render it likely to be read and understood by

the ordinary individual under customary conditions of purchase and use.

(d) [Repealed] 4

(e) Designation of drugs or devices by established names.

(1)(A) If it is a drug, unless its label bears, to the exclusion of any other nonproprietary name

(except the applicable systematic chemical name or the chemical formula)

(i) the established name (as defined in subparagraph (3)) of the drug, if there is such a name;

(ii) the established name and quantity or, if determined to be appropriate by the Secretary, the

proportion of each active ingredient, including the quantity, kind, and proportion of any alcohol,

and also including whether active or not the established name and quantity or if determined to

be appropriate by the Secretary, the proportion of any bromides, ether, chloroform, acetanilide,

acetophenetidin, amidopyrine, antipyrine, atropine, hyoscine, hyoscyamine, arsenic, digitalis,

digitalis glucosides, mercury, ouabain, strophanthin, strychnine, thyroid, or any derivative or

preparation of any such substances, contained therein, except that the requirement for stating

the quantity of the active ingredients, other than the quantity of those specifically named in this

subclause, shall not apply to nonprescription drugs not intended for human use; and

(iii) the established name of each inactive ingredient listed in alphabetical order on the outside

container of the retail package and, if determined to be appropriate by the Secretary, on the

immediate container, as prescribed in regulation promulgated by the Secretary, except that

nothing in this subclause shall be deemed to require that any trade secret be divulged, and

except that the requirements of this subclause with respect to alphabetical order shall apply

only to nonprescription drugs that are not also cosmetics and that this subclause shall not

apply to nonprescription drugs not intended for human use.

(B) For any prescription drug the established name of such drug or ingredient, as the case may

be, on such label (and on any labeling on which a name for such drug or ingredient is used)

shall be printed prominently and in type at least half as large as that used thereon for any

proprietary name or designation for such drug or ingredient, except that to the extent that

compliance with the requirements of subclause (ii) or (iii) of clause (A) or this clause is

impracticable, exemptions shall be established by regulations promulgated by the Secretary.

(2) If it is a device and it has an established name, unless its label bears, to the exclusion of

any other nonproprietary name, its established name (as defined in subparagraph (4))

prominently printed in type at least half as large as that used thereon for any proprietary name

or designation for such device, except that to the extent compliance with the requirements of

this subparagraph is impracticable, exemptions shall be established by regulations

promulgated by the Secretary.

(3) As used in subparagraph (1), the term "established name", with respect to a drug or

ingredient thereof, means (A) the applicable official name designated pursuant to section 508,

or (B) if there is no such name and such drug, or such ingredient, is an article recognized in an

official compendium, then the official title thereof in such compendium, or (C) if neither clause

(A) nor clause (B) of this subparagraph applies, then the common or usual name, if any, of

such drug or of such ingredient, except that where clause (B) of this subparagraph applies to

an article recognized in the United States Pharmacopeia and in the Homoeopathic

Pharmacopoeia under different official titles, the official title used in the United States

Pharmacopeia shall apply unless it is labeled and offered for sale as a homoeopathic drug, in

which case the official title used in the Homoeopathic Pharmacopoeia shall apply.

(4) As used in subparagraph (2), the term "established name" with respect to a device means

(A) the applicable official name of the device designated pursuant to section 508, (B) if there is

no such name and such device is an article recognized in an official compendium, then the

official title thereof in such compendium, or (C) if neither clause (A) nor clause (B) of this

subparagraph applies, then any common or usual name of such device.

(f) Directions for use and warnings on label. Unless its labeling bears (1) adequate directions

for use; and (2) such adequate warnings against use in those pathological conditions or by

children where its use may be dangerous to health, or against unsafe dosage or methods or

duration of administration or application, in such manner and form, as are necessary for the

protection of users, except that where any requirement of clause (1) of this paragraph, as

applied to any drug or device, is not necessary for the protection of the public health, the

Secretary shall promulgate regulations exempting such drug or device from such requirement.

Required labeling for prescription devices intended for use in health care facilities or by a

health care professional and required labeling for in vitro diagnostic devices intended for use

by health care professionals or in blood establishments may be made available solely by

electronic means, provided that the labeling complies with all applicable requirements of law,

and that the manufacturer affords such users the opportunity to request the labeling in paper

form, and after such request, promptly provides the requested information without additional

cost.

(g) Representations as recognized drug; packing and labeling; inconsistent requirements for

designation of drug. If it purports to be a drug the name of which is recognized in an official

compendium, unless it is packaged and labeled as prescribed therein. The method of packing

may be modified with the consent of the Secretary. Whenever a drug is recognized in both the

United States Pharmacopoeia and the Homoeopathic Pharmacopoeia of the United States, it

shall be subject to the requirements of the United States Pharmacopoeia with respect to

packaging and labeling unless it is labeled and offered for sale as a homoeopathic drug, in

which case it shall be subject to the provisions of the Homoeopathic Pharmacopoeia of the

United States, and not to those of the United States Pharmacopeia, except that in the event of

inconsistency between the requirements of this paragraph and those of paragraph (e) as to the

name by which the drug or its ingredients shall be designated, the requirements of paragraph

(e) shall prevail.

(h) Deteriorative drugs; packing and labeling. If it has been found by the Secretary to be a drug

liable to deterioration, unless it is packaged in such form and manner, and its label bears a

statement of such precautions, as the Secretary shall by regulations require as necessary for

the protection of the public health. No such regulation shall be established for any drug

recognized in an official compendium until the Secretary shall have informed the appropriate

body charged with the revision of such compendium of the need for such packaging or labeling

requirements and such body shall have failed within a reasonable time to prescribe such

requirements.

(i) Drug; misleading container; imitation; offer for sale under another name. (1) If it is a drug

and its container is so made, formed, or filled as to be misleading; or (2) if it is an imitation of

another drug; or (3) if it is offered for sale under the name of another drug.

(j) Health-endangering when used as prescribed. If it is dangerous to health when used in the

dosage or manner; or with the frequency or duration prescribed, recommended, or suggested

in the labeling thereof.

(k), (l) [Repealed] 5

(m) Color additives; packing and labeling. If it is a color additive the intended use of which is for

the purpose of coloring only, unless its packaging and labeling are in conformity with such

packaging and labeling requirements applicable to such color additive, as may be contained in

regulations issued under section 721.

(n) Prescription drug advertisements: established name; quantitative formula; side effects,

contraindications, and effectiveness; prior approval; false advertising; labeling; construction of

the Convention on Psychotropic Substances. In the case of any prescription drug distributed or

offered for sale in any State, unless the manufacturer, packer, or distributor thereof includes in

all advertisements and other descriptive printed matter issued or caused to be issued by the

manufacturer, packer, or distributor with respect to that drug a true statement of (1) the

established name as defined in section 502(e) 6 [subsec. (e) of this section], printed

prominently and in type at least half as large as that used for any trade or brand name thereof,

(2) the formula showing quantitatively each ingredient of such drug to the extent required for

labels under section 502(e) [subsec. (e) of this section] 6, and (3) such other information in

brief summary relating to side effects, contraindications, and effectiveness as shall be required

in regulations which shall be issued by the Secretary in accordance with the procedure

specified in section 701(e) of this Act, except that (A) except in extraordinary circumstances,

no regulation issued under this paragraph shall require prior approval by the Secretary of the

content of any advertisement, and (B) no advertisement of a prescription drug, published after

the effective date of regulations issued under this paragraph applicable to advertisements of

prescription drugs, shall, with respect to the matters specified in this paragraph or covered by

such regulations, be subject to the provisions of sections 12 through 17 of the Federal Trade

Commission Act, as amended [15 USC 52–57]. This paragraph (n) 7 shall not be applicable to

any printed matter which the Secretary determines to be labeling as defined in section 201(m)

of this Act. Nothing in the Convention on Psychotropic Substances, signed at Vienna, Austria,

on February 21, 1971, shall be construed to prevent drug price communications to consumers.

8

(o) Drugs or devices from nonregistered establishments. If it was manufactured, prepared,

propagated, compounded, or processed in an establishment in any State not duly registered

under section 510, if it was not included in a list required by section 510(j), if a notice or other

information respecting it was not provided as required by such section or section 510(k), or if it

does not bear such symbols from the uniform system for identification of devices prescribed

under section 510(e) as the Secretary by regulation requires.

(p) Packaging or labeling of drugs in violation of regulations. If it is a drug and its packaging or

labeling is in violation of an applicable regulation issued pursuant to section 3 or 4 of the

Poison Prevention Packaging Act of 1970 [15 USCS § 1472 or 1473].

(q) Restricted devices using false or misleading advertising or used in violation of regulations.

In the case of any restricted device distributed or offered for sale in any State, if (1) its

advertising is false or misleading in any particular, or (2) it is sold, distributed, or used in

violation of regulations prescribed under section 520(e).

(r) Restricted devices not carrying requisite accompanying statements in advertisements and

other descriptive printed matter. In the case of any restricted device distributed or offered for

sale in any State, unless the manufacturer, packer, or distributor thereof includes in all

advertisements and other descriptive printed matter issued or caused to be issued by the

manufacturer, packer, or distributor with respect to that device (1) a true statement of the

device’s established name as defined in section 502(e), printed prominently and in type at

least half as large as that used for any trade or brand name thereof, and (2) a brief statement

of the intended uses of the device and relevant warnings, precautions, side effects, and

contraindications and, in the case of specific devices made subject to a finding by the

Secretary after notice and opportunity for comment that such action is necessary to protect the

public health, a full description of the components of such device or the formula showing

quantitatively each ingredient of such device to the extent required in regulations which shall

be issued by the Secretary after an opportunity for a hearing. Except in extraordinary

circumstances, no regulation issued under this paragraph shall require prior approval by the

Secretary of the content of any advertisement and no advertisement of a restricted device,

published after the effective date of this paragraph shall, with respect to the matters specified

in this paragraph or covered by regulations issued hereunder, be subject to the provisions of

sections 12 through 15 of the Federal Trade Commission Act [15 U.S.C. 52–55]. This

paragraph shall not be applicable to any printed matter which the Secretary determines to be

labeling as defined in section 201(m).

(s) Devices subject to performance standards not bearing requisite labeling. If it is a device

subject to a performance standard established under section 514, unless it bears such labeling

as may be prescribed in such performance standard.

(t) Devices for which there has been a failure or refusal to give required notification or to

furnish required material or information. If it is a device and there was a failure or refusal (1) to

comply with any requirement prescribed under section 518 respecting the device, (2) to furnish

any material or information required by or under section 519 respecting the device, or (3) to

comply with a requirement under section 522.

9 (u) Identification of manufacturer.

(1) Subject to paragraph (2), if it is a reprocessed single-use device, unless it, or an

attachment thereto, prominently and conspicuously bears the name of the manufacturer of the

reprocessed device, a generally recognized abbreviation of such name, or a unique and

generally recognized symbol identifying such manufacturer.

(2) If the original device or an attachment thereto does not prominently and conspicuously bear

the name of the manufacturer of the original device, a generally recognized abbreviation of

such name, or a unique and generally recognized symbol identifying such manufacturer, a

reprocessed device may satisfy the requirements of paragraph (1) through the use of a

detachable label on the packaging that identifies the manufacturer and is intended to be

affixed to the medical record of a patient.

10 (v) Reprocessed single-use device. If it is a reprocessed single-use device, unless all

labeling of the device prominently and conspicuously bears the statement "Reprocessed

device for single use. Reprocessed by ------." The name of the manufacturer of the

reprocessed device shall be placed in the space identifying the person responsible for

reprocessing.

(w) New animal drugs. If it is a new animal drug—

(1) that is conditionally approved under section 571 and its labeling does not conform with the

approved application or section 571(f), or that is not conditionally approved under section 571

and its label bears the statement set forth in section 571(f)(1)(A); or

(2) that is indexed under section 572 and its labeling does not conform with the index listing

under section 572(e) or 572(h), or that has not been indexed under section 572 and its label

bears the statement set forth in section 572(h).

(x) [Caution: This subsection is effective and applicable to any nonprescription drug

labeled on or after the date that is 1 year after enactment, pursuant to § 2(e)(1), (2) of Act

Dec. 22, 2006, P.L. 109-462, which appears as a note to this section.]. If it is a

nonprescription drug (as defined in section 760) that is marketed in the United States, unless

the label of such drug includes a domestic address or domestic phone number through which

the responsible person (as described in section 760) may receive a report of a serious adverse

event (as defined in section 760) with such drug.

EXEMPTIONS AND CONSIDERATION FOR CERTAIN DRUGS, DEVICES, AND

BIOLOGICAL PRODUCTS

SEC. 503. (21 U.S.C. 353) (a) The Secretary is hereby directed to promulgate regulations

exempting from any labeling or packaging requirement of this Act drugs and devices which are,

in accordance with the practice of the trade, to be processed, labeled, or repacked in

substantial quantities at establishments other than those where originally processed or packed,

on condition that such drugs and devices are not adulterated or misbranded, under the

provisions of this Act upon removal from such processing, labeling, or repacking

establishment.

(b)(1) A drug intended for use by man which—

(A) because of its toxicity or other potentiality for harmful effect, or the method of its use, or the

collateral measures necessary to its use, is not safe for use except under the supervision of a

practitioner licensed by law to administer such drug; or

(B) is limited by an approved application under section 505 to use under the professional

supervision of a practitioner licensed by law to administer such drug; shall be dispensed only (i)

upon a written prescription of a practitioner licensed by law to administer such drug, or (ii) upon

an oral prescription of such practitioner which is reduced promptly to writing and filed by the

pharmacist, or (iii) by refilling any such written or oral prescription if such refilling is authorized

by the prescriber either in the original prescription or by oral order which is reduced promptly to

writing and filed by the pharmacist. The act of dispensing a drug contrary to the provisions of

this paragraph shall be deemed to be an act which results in the drug being misbranded while

held for sale.

(2) Any drug dispensed by filling or refilling a written or oral prescription of a practitioner

licensed by law to administer such drug shall be exempt from the requirements of section 502,

except paragraphs (a), (i) (2) and (3), (k), and (l), and the packaging requirements of

paragraphs (g), (h), and (p), if the drug bears a label containing the name and address of the

dispenser, the serial number and date of the prescription or of its filling, the name of the

prescriber, and, if stated in the prescription, the name of the patient, and the directions for use

and cautionary statements, if any, contained in such prescription. This exemption shall not

apply to any drug dispensed in the course of the conduct of a business of dispensing drugs

pursuant to diagnosis by mail, or to a drug dispensed in violation of paragraph (1) of this

subsection.

(3) The Secretary may by regulation remove drugs subject to section 505 from the

requirements of paragraph (1) of this subsection when such requirements are not necessary

for the protection of the public health.

(4)(A) A drug that is subject to paragraph (1) shall be deemed to be misbranded if at any time

prior to dispensing the label of the drug fails to bear, at a minimum, the symbol ‘‘Rx only’’.

(B) A drug to which paragraph (1) does not apply shall be deemed to be misbranded if at any

time prior to dispensing the label of the drug bears the symbol described in subparagraph (A).

(5) Nothing in this subsection shall be construed to relieve any person from any requirement

prescribed by or under authority of law with respect to drugs now included or which may

hereafter be included within the classifications stated in section 3220 of the Internal Revenue

Code (26 U.S.C. 3220), or to marihuana as defined in section 3238(b) of the Internal Revenue

Code (26 U.S.C. 3238(b)).

(c)(1) No person may sell, purchase, or trade or offer to sell, purchase, or trade any drug

sample. For purposes of this paragraph and subsection (d), the term ‘‘drug sample’’ means a

unit of a drug, subject to subsection (b), which is not intended to be sold and is intended to

promote the sale of the drug. Nothing in this paragraph shall subject an officer or executive of

a drug manufacturer or distributor to criminal liability solely because of a sale, purchase, trade,

or offer to sell, purchase, or trade in violation of this paragraph by other employees of the

manufacturer or distributor.

(2) No person may sell, purchase, or trade, offer to sell, purchase, or trade, or counterfeit any

coupon. For purposes of this paragraph, the term ‘‘coupon’’ means a form which may be

redeemed, at no cost or at a reduced cost, for a drug which is prescribed in accordance with

subsection (b).

(3)(A) No person may sell, purchase, or trade, or offer to sell, purchase, or trade, any drug—

(i) which is subject to subsection (b), and

(ii)(I) which was purchased by a public or private hospital or other health care entity, or

(II) which was donated or supplied at a reduced price to a charitable organization described in

section 501(c)(3) of the Internal Revenue Code of 1954.

(B) Subparagraph (A) does not apply to—

(i) the purchase or other acquisition by a hospital or other health care entity which is a member

of a group purchasing organization of a drug for its own use from the group purchasing

organization or from other hospitals or health care entities which are members of such

organization,

(ii) the sale, purchase, or trade of a drug or an offer to sell, purchase, or trade a drug by an

organization described in subparagraph (A)(ii)(II) to a nonprofit affiliate of the organization to

the extent otherwise permitted by law,

(iii) a sale, purchase, or trade of a drug or an offer to sell, purchase, or trade a drug among

hospitals or other health care entities which are under common control,

(iv) a sale, purchase, or trade of a drug or an offer to sell, purchase, or trade a drug for

emergency medical reasons, or

(v) a sale, purchase, or trade of a drug, an offer to sell, purchase, or trade a drug, or the

dispensing of a drug pursuant to a prescription executed in accordance with subsection (b).

For purposes of this paragraph, the term ‘‘entity’’ does not include a wholesale distributor of

drugs or a retail pharmacy licensed under State law and the term ‘‘emergency medical

reasons’’ includes transfers of a drug between health care entities or from a health care entity

to a retail pharmacy undertaken to alleviate temporary shortages of the drug arising from

delays in or interruptions of regular distribution schedules.

(d)(1) Except as provided in paragraphs (2) and (3), no person may distribute any drug sample.

For purposes of this subsection, the term ‘‘distribute’’ does not include the providing of a drug

sample to a patient by a—

(A) practitioner licensed to prescribe such drug,

(B) health care professional acting at the direction and under the supervision of such a

practitioner, or

(C) pharmacy of a hospital or of another health care entity that is acting at the direction of such

a practitioner and that received such sample pursuant to paragraph (2) or (3).

(2)(A) The manufacturer or authorized distributor of record of a drug subject to subsection (b)

may, in accordance with this paragraph, distribute drug samples by mail or common carrier to

practitioners licensed to prescribe such drugs or, at the request of a licensed practitioner, to

pharmacies of hospitals or other health care entities. Such a distribution of drug samples may

only be made—

(i) in response to a written request for drug samples made on a form which meets the

requirements of subparagraph (B), and

(ii) under a system which requires the recipient of the drug sample to execute a written receipt

for the drug sample upon its delivery and the return of the receipt to the manufacturer or

authorized distributor of record.

(B) A written request for a drug sample required by subparagraph (A)(i) shall contain—

(i) the name, address, professional designation, and signature of the practitioner making the

request,

(ii) the identity of the drug sample requested and the quantity requested,

(iii) the name of the manufacturer of the drug sample requested, and

(iv) the date of the request.

(C) Each drug manufacturer or authorized distributor of record which makes distributions by

mail or common carrier under this paragraph shall maintain, for a period of 3 years, the request

forms submitted for such distributions and the receipts submitted for such distributions and

shall maintain a record of distributions of drug samples which identifies the drugs distributed

and the recipients of the distributions. Forms, receipts, and records required to be maintained

under this subparagraph shall be made available by the drug manufacturer or authorized

distributor of record to Federal and State officials engaged in the regulation of drugs and in the

enforcement of laws applicable to drugs.

(3) The manufacturer or authorized distributor of record of a drug subject to subsection (b) may,

by means other than mail or common carrier, distribute drug samples only if the manufacturer

or authorized distributor of record makes the distributions in accordance with subparagraph (A)

and carries out the activities described in subparagraphs (B) through (F) as follows:

(A) Drug samples may only be distributed—

(i) to practitioners licensed to prescribe such drugs if they make a written request for the drug

samples, or

(ii) at the written request of such a licensed practitioner, to pharmacies of hospitals or other

health care entities. A written request for drug samples shall be made on a form which

contains the practitioner’s name, address, and professional designation, the identity of the

drug sample requested, the quantity of drug samples requested, the name of the manufacturer

or authorized distributor of record of the drug sample, the date of the request and signature of

the practitioner making the request.

(B) Drug manufacturers or authorized distributors of record shall store drug samples under

conditions that will maintain their stability, integrity, and effectiveness and will assure that the

drug samples will be free of contamination, deterioration, and adulteration.

(C) Drug manufacturers or authorized distributors of record shall conduct, at least annually, a

complete and accurate inventory of all drug samples in the possession of representatives of

the manufacturer or authorized distributor of record. Drug manufacturers or authorized

distributors of record shall maintain lists of the names and address of each of their

representatives who distribute drug samples and of the sites where drug samples are stored.

Drug manufacturers or authorized distributors of record shall maintain records for at least 3

years of all drug samples distributed, destroyed, or returned to the manufacturer or authorized

distributor of record, of all inventories maintained under this subparagraph, of all thefts or

significant losses of drug samples, and of all requests made under subparagraph (A) for drug

samples. Records and lists maintained under this subparagraph shall be made available by

the drug manufacturer or authorized distributor of record to the Secretary upon request.

(D) Drug manufacturers or authorized distributors of record shall notify the Secretary of any

significant loss of drug samples and any known theft of drug samples.

(E) Drug manufacturers or authorized distributors of record shall report to the Secretary any

conviction of their representatives for violations of subsection (c)(1) or a State law because of

the sale, purchase, or trade of a drug sample or the offer to sell, purchase, or trade a drug

sample.

(F) Drug manufacturers or authorized distributors of record shall provide to the Secretary the

name and telephone number of the individual responsible for responding to a request for

information respecting drug samples.

(e)(1)(A) Each person who is engaged in the wholesale distribution of a drug subject to

subsection (b) and who is not the manufacturer or an authorized distributor of record of such

drug shall, before each wholesale distribution of such drug (including each distribution to an

authorized distributor of record or to a retail pharmacy), provide to the person who receives the

drug a statement (in such form and containing such information as the Secretary may require)

identifying each prior sale, purchase, or trade of such drug (including the date of the

transaction and the names and addresses of all parties to the transaction).

(B) Each manufacturer of a drug subject to subsection (b) shall maintain at its corporate offices

a current list of the authorized distributors of record of such drug.

(2)(A) No person may engage in the wholesale distribution in interstate commerce of drugs

subject to subsection (b) in a State unless such person is licensed by the State in accordance

with the guidelines issued under subparagraph (B).

(B) The Secretary shall by regulation issue guidelines establishing minimum standards, terms,

and conditions for the licensing of persons to make wholesale distributions in interstate

commerce of drugs subject to subsection (b). Such guidelines shall prescribe requirements for

the storage and handling of such drugs and for the establishment and maintenance of records

of the distributions of such drugs.

(3) For the purposes of this subsection and subsection (d)—

(A) the term ‘‘authorized distributors of record’’ means those distributors with whom a

manufacturer has established an ongoing relationship to distribute such manufacturer’s

products, and

(B) the term ‘‘wholesale distribution’’ means distribution of drugs subject to subsection (b) to

other than the consumer or patient but does not include intracompany sales and does not

include distributions of drugs described in subsection (c)(3)(B).

(f)(1)(A) A drug intended for use by animals other than man, other than a veterinary feed

directive drug intended for use in animal feed or an animal feed bearing or containing a

veterinary feed directive drug, which—

(i) because of its toxicity or other potentiality for harmful effect, or the method of its use, or the

collateral measures necessary for its use, is not safe for animal use except under the

professional supervision of a licensed veterinarian, or

(ii) is limited by an approved application under subsection (b) of section 512, a

conditionally-approved application under section 571, or an index listing under section 572 to

use under the professional supervision of a licensed veterinarian, shall be dispensed only by

or upon the lawful written or oral order of a licensed veterinarian in the course of the

veterinarian’s professional practice.

(B) For purposes of subparagraph (A), an order is lawful if the order—

(i) is a prescription or other order authorized by law,

(ii) is, if an oral order, promptly reduced to writing by the person lawfully filling the order, and

filed by that person, and

(iii) is refilled only if authorized in the original order or in a subsequent oral order promptly

reduced to writing by the person lawfully filling the order, and filed by that person.

(C) The act of dispensing a drug contrary to the provisions of this paragraph shall be deemed

to be an act which results in the drug being misbranded while held for sale.

(2) Any drug when dispensed in accordance with paragraph (1) of this subsection—

(A) Shall be exempt from the requirements of section 502, except subsections (a), (g), (h),

(i)(2), (i)(3), and (p) of such section, and

(B) shall be exempt from the packaging requirements of subsections (g), (h), and (p) of such

section, if—

(i) when dispensed by a licensed veterinarian, the drug bears a label containing the name and

address of the practitioner and any directions for use and cautionary statements specified by

the practitioner, or

(ii) when dispensed by filling the lawful order of a licensed veterinarian, the drug bears a label

containing the name and address of the dispenser, the serial number and date of the order or

of its filing, the name of the licensed veterinarian, and the directions for use and cautionary

statements, if any, contained in such order.

The preceding sentence shall not apply to any drug dispensed in the course of the conduct of

a business of dispensing drugs pursuant to diagnosis by mail.

(3) The Secretary may by regulation exempt drugs for animals other than man subject to

section 512, 571, or 572 from the requirements of paragraph (1) when such requirements are

not necessary for the protection of the public health.

(4) A drug which is subject to paragraph (1) shall be deemed to be misbranded if at any time

prior to dispensing its label fails to bear the statement ‘‘Caution: Federal law restricts this drug

to use by or on the order of a licensed veterinarian.’’. A drug to which paragraph (1) does not

apply shall be deemed to be misbranded if at any time prior to dispensing its label bears the

statement specified in the preceding sentence.

(g)(1) The Secretary shall in accordance with this subsection assign an agency center to

regulate products that constitute a combination of a drug, device, or biological product. The

Secretary shall determine the primary mode of action of the combination product. If the

Secretary determines that the primary mode of action is that of—

(A) a drug (other than a biological product), the agency center charged with premarket review

of drugs shall have primary jurisdiction,

(B) a device, the agency center charged with premarket review of devices shall have primary

jurisdiction, or

(C) a biological product, the agency center charged with premarket review of biological

products shall have primary jurisdiction.

(2) Nothing in this subsection shall prevent the Secretary from using any agency resources of

the Food and Drug Administration necessary to ensure adequate review of the safety,

effectiveness, or substantial equivalence of an article.

(3) The Secretary shall promulgate regulations to implement market clearance procedures in

accordance with paragraphs (1) and (2) not later than 1 year after the date of enactment of this

subsection. 11

(4) (A) Not later than 60 days after the date of the enactment of this paragraph 12, the

Secretary shall establish within the Office of the Commissioner of Food and Drugs an office to

ensure the prompt assignment of combination products to agency centers, the timely and

effective premarket review of such products, and consistent and appropriate postmarket

regulation of like products subject to the same statutory requirements to the extent permitted

by law. Additionally, the office shall, in determining whether a product is to be designated a

combination product, consult with the component within the Office of the Commissioner of

Food and Drugs that is responsible for such determinations. Such office (referred to in this

paragraph as the `Office') shall have appropriate scientific and medical expertise, and shall be

headed by a director.

(B) In carrying out this subsection, the Office shall, for each combination product, promptly

assign an agency center with primary jurisdiction in accordance with paragraph (1) for the

premarket review of such product.

(C)(i) In carrying out this subsection, the Office shall ensure timely and effective premarket

reviews by overseeing the timeliness of and coordinating reviews involving more than one

agency center.

(ii) In order to ensure the timeliness of the premarket review of a combination product, the

agency center with primary jurisdiction for the product, and the consulting agency center, shall

be responsible to the Office with respect to the timeliness of the premarket review.

(D) In carrying out this subsection, the Office shall ensure the consistency and

appropriateness of postmarket regulation of like products subject to the same statutory

requirements to the extent permitted by law.

(E)(i) Any dispute regarding the timeliness of the premarket review of a combination product

may be presented to the Office for resolution, unless the dispute is clearly premature.

(ii) During the review process, any dispute regarding the substance of the premarket review

may be presented to the Commissioner of Food and Drugs after first being considered by the

agency center with primary jurisdiction of the premarket review, under the scientific dispute

resolution procedures for such center. The Commissioner of Food and Drugs shall consult with

the Director of the Office in resolving the substantive dispute.

(F) The Secretary, acting through the Office, shall review each agreement, guidance, or

practice of the Secretary that is specific to the assignment of combination products to agency

centers and shall determine whether the agreement, guidance, or practice is consistent with

the requirements of this subsection. In carrying out such review, the Secretary shall consult

with stakeholders and the directors of the agency centers. <> After such consultation, the

Secretary shall determine whether to continue in effect, modify, revise, or eliminate such

agreement, guidance, or practice, and shall publish in the Federal Register a notice of the

availability of such modified or revised agreement, guidance or practice. Nothing in this

paragraph shall be construed as preventing the Secretary from following each agreement,

guidance, or practice until continued, modified, revised, or eliminated.

(G) Not later than one year after the date of the enactment of this paragraph and annually

thereafter, the Secretary shall report to the appropriate committees of Congress on the

activities and impact of the Office. The report shall include provisions--

(i) describing the numbers and types of combination products under review and the timeliness

in days of such assignments, reviews, and dispute resolutions;

(ii) identifying the number of premarket reviews of such products that involved a consulting

agency center; and

(iii) describing improvements in the consistency of postmarket regulation of combination

products.

(H) Nothing in this paragraph shall be construed to limit the regulatory authority of any agency

center.

(5) As used in this subsection:

(A) The term `agency center' means a center or alternative organizational component of the

Food and Drug Administration.

(B) The term ‘‘biological product’’ has the meaning given the term in section 351(i) of the Public

Health Service Act (42 U.S.C. 262(i)).

(C) The term ‘‘market clearance’’ includes—

(i) approval of an application under section 505, 507, 515, or 520(g),

(ii) a finding of substantial equivalence under this subchapter, and

(iii) approval of a biologics license application under subsection (a) of section 351 of the Public

Health Service Act (42 U.S.C. 262).

SEC. 503A. [ 21 U.S.C. 353a] PHARMACY COMPOUNDING.

(a) IN GENERAL.—Sections 501(a)(2)(B), 502(f)(1), and 505 shall not apply to a drug product

if the drug product is compounded for an identified individual patient based on the unsolicited

receipt of a valid prescription order or a notation, approved by the prescribing practitioner, on

the prescription order that a compounded product is necessary for the identified patient, if the

drug product meets the requirements of this section, and if the compounding—

(1) is by—

(A) a licensed pharmacist in a State licensed pharmacy or a Federal facility, or

(B) a licensed physician, on the prescription order for such individual patient made by a

licensed physician or other licensed practitioner authorized by State law to prescribe drugs; or

(2)(A) is by a licensed pharmacist or licensed physician in limited quantities before the receipt

of a valid prescription order for such individual patient; and

(B) is based on a history of the licensed pharmacist or licensed physician receiving valid

prescription orders for the compounding of the drug product, which orders have been

generated solely within an established relationship between—

(i) the licensed pharmacist or licensed physician; and

(ii)(I) such individual patient for whom the prescription order will be provided; or

(II) the physician or other licensed practitioner who will write such prescription order.

(b) COMPOUNDED DRUG.—

(1) LICENSED PHARMACIST AND LICENSED PHYSICIAN.—A drug product may be

compounded under subsection (a) if the licensed pharmacist or licensed physician—

(A) compounds the drug product using bulk drug substances, as defined in regulations of the

Secretary published at section 207.3(a)(4) of title 21 of the Code of Federal Regulations—

(i) that—

(I) comply with the standards of an applicable United States Pharmacopoeia or National

Formulary monograph, if a monograph exists, and the United States Pharmacopoeia chapter

on pharmacy compounding;

(II) if such a monograph does not exist, are drug substances that are components of drugs

approved by the Secretary; or

(III) if such a monograph does not exist and the drug substance is not a component of a drug

approved by the Secretary, that appear on a list developed by the Secretary through

regulations issued by the Secretary under subsection (d);

(ii) that are manufactured by an establishment that is registered under section 510 (including a

foreign establishment that is registered under section 510(i)); and

(iii) that are accompanied by valid certificates of analysis for each bulk drug substance;

(B) compounds the drug product using ingredients (other than bulk drug substances) that

comply with the standards of an applicable United States Pharmacopoeia or National

Formulary monograph, if a monograph exists, and the United States Pharmacopoeia chapter

on pharmacy compounding;

(C) does not compound a drug product that appears on a list published by the Secretary in the

Federal Register of drug products that have been withdrawn or removed from the market

because such drug products or components of such drug products have been found to be

unsafe or not effective; and

(D) does not compound regularly or in inordinate amounts (as defined by the Secretary) any

drug products that are essentially copies of a commercially available drug product.

(2) DEFINITION.—For purposes of paragraph (1)(D), the term ‘‘essentially a copy of a

commercially available drug product’’ does not include a drug product in which there is a

change, made for an identified individual patient, which produces for that patient a significant

difference, as determined by the prescribing practitioner, between the compounded drug and

the comparable commercially available drug product.

(3) DRUG PRODUCT.—A drug product may be compounded under subsection (a) only if—

(A) such drug product is not a drug product identified by the Secretary by regulation as a drug

product that presents demonstrable difficulties for compounding that reasonably demonstrate

an adverse effect on the safety or effectiveness of that drug product; and

(B) such drug product is compounded in a State—

(i) that has entered into a memorandum of understanding with the Secretary which addresses

the distribution of inordinate amounts of compounded drug products interstate and provides for

appropriate investigation by a State agency of complaints relating to compounded drug

products distributed outside such State; or

(ii) that has not entered into the memorandum of understanding described in clause (i) and the

licensed pharmacist, licensed pharmacy, or licensed physician distributes (or causes to be

distributed) compounded drug products out of the State in which they are compounded in

quantities that do not exceed 5 percent of the total prescription orders dispensed or distributed

by such pharmacy or physician.

The Secretary shall, in consultation with the National Association of Boards of Pharmacy,

develop a standard memorandum of understanding for use by the States in complying with

subparagraph (B)(i).

(c) ADVERTISING AND PROMOTION.—A drug may be compounded under subsection (a)

only if the pharmacy, licensed pharmacist, or licensed physician does not advertise or promote

the compounding of any particular drug, class of drug, or type of drug. The pharmacy, licensed

pharmacist, or licensed physician may advertise and promote the compounding service

provided by the licensed pharmacist or licensed physician.

(d) REGULATIONS.—

(1) IN GENERAL.—The Secretary shall issue regulations to implement this section. Before

issuing regulations to implement subsections (b)(1)(A)(i)(III), (b)(1)(C), or (b)(3)(A), the

Secretary shall convene and consult an advisory committee on compounding unless the

Secretary determines that the issuance of such regulations before consultation is necessary to

protect the public health. The advisory committee shall include representatives from the

National Association of Boards of Pharmacy, the United States Pharmacopoeia, pharmacy,

physician, and consumer organizations, and other experts selected by the Secretary.

(2) LIMITING COMPOUNDING.—The Secretary, in consultation with the United States

Pharmacopoeia Convention, Incorporated, shall promulgate regulations identifying drug

substances that may be used in compounding under subsection (b)(1)(A)(i)(III) for which a

monograph does not exist or which are not components of drug products approved by the

Secretary. The Secretary shall include in the regulation the criteria for such substances, which

shall include historical use, reports in peer reviewed medical literature, or other criteria the

Secretary may identify.

(e) APPLICATION.—This section shall not apply to—

(1) compounded positron emission tomography drugs as defined in section 201(ii); or

(2) radiopharmaceuticals.

(f) DEFINITION.—As used in this section, the term ‘‘compounding’’ does not include mixing,

reconstituting, or other such acts that are performed in accordance with directions contained in

approved labeling provided by the product’s manufacturer and other manufacturer directions

consistent with that labeling.

VETERINARY FEED DIRECTIVE DRUGS

SEC. 504. [21 U.S.C. 354] (a)(1) A drug intended for use in or on animal feed which is limited

by an approved application filed pursuant to section 512(b), a conditionally-approved

application filed pursuant to section 571, or an index listing pursuant to section 572 to use

under the professional supervision of a licensed veterinarian is a veterinary feed directive drug.

Any animal feed bearing or containing a veterinary feed directive drug shall be fed to animals

only by or upon a lawful veterinary feed directive issued by a licensed veterinarian in the

course of the veterinarian’s professional practice. When labeled, distributed, held, and used in

accordance with this section, a veterinary feed directive drug and any animal feed bearing or

containing a veterinary feed directive drug shall be exempt from section 502(f).

(2) A veterinary feed directive is lawful if it—

(A) contains such information as the Secretary may by general regulation or by order require;

and

(B) is in compliance with the conditions and indications for use of the drug set forth in the

notice published pursuant to section 512(i), or the index listing pursuant to section 572(e).

(3)(A) Any persons involved in the distribution or use of animal feed bearing or containing a

veterinary feed directive drug and the licensed veterinarian issuing the veterinary feed

directive shall maintain a copy of the veterinary feed directive applicable to each such feed,

except in the case of a person distributing such feed to another person for further distribution.

Such person distributing the feed shall maintain a written acknowledgment from the person to

whom the feed is shipped stating that that person shall not ship or move such feed to an

animal production facility without a veterinary feed directive or ship such feed to another

person for further distribution unless that person has provided the same written

acknowledgment to its immediate supplier.

(B) Every person required under subparagraph (A) to maintain records, and every person in

charge or custody thereof, shall, upon request of an officer or employee designated by the

Secretary, permit such officer or employee at all reasonable times to have access to and copy

and verify such records.

(C) Any person who distributes animal feed bearing or containing a veterinary feed directive

drug shall upon first engaging in such distribution notify the Secretary of that person’s name

and place of business. The failure to provide such notification shall be deemed to be an act

which results in the drug being misbranded.

(b) A veterinary feed directive drug and any feed bearing or containing a veterinary feed

directive drug shall be deemed to be misbranded if their labeling fails to bear such cautionary

statement and such other information as the Secretary may by general regulation or by order

prescribe, or their advertising fails to conform to the conditions and indications for use

published pursuant to section 512(i), or the index listing pursuant to section 572(e) or fails to

contain the general cautionary statement prescribed by the Secretary.

(c) Neither a drug subject to this section, nor animal feed bearing or containing such a drug,

shall be deemed to be a prescription article under any Federal or State law.

NEW DRUGS

SEC. 505. [21 U.S.C. 355] (a) No person shall introduce or deliver for introduction into

interstate commerce any new drug, unless an approval of an application filed pursuant to

subsection (b) or (j) is effective with respect to such drug.

(b)(1) Any person may file with the Secretary an application with respect to any drug subject to

the provisions of subsection (a). Such persons shall submit to the Secretary as a part of the

application (A) full reports of investigations which have been made to show whether or not

such drug is safe for use and whether such drug is effective in use; 13 (B) a full list of the

articles used as components of such drug; (C) a full statement of the composition of such drug;

(D) a full description of the methods used in, and the facilities and controls used for, the

manufacture, processing, and packing of such drug; (E) such samples of such drug and of the

articles used as components thereof as the Secretary may require; (F) specimens of the

labeling proposed to be used for such drug and (G) any assessments required under section

505B. The applicant shall file with the application the patent number and the expiration date of

any patent which claims the drug for which the applicant submitted the application or which

claims a method of using such drug and with respect to which a claim of patent infringement

could reasonably be asserted if a person not licensed by the owner engaged in the

manufacture use, or sale of the drug. If a application is filed under this subsection for a drug

and a patent which claims such drug or a method of using such drug is issued after the filing

date but before approval of the application, the applicant shall amend the application to include

the information required by the preceding sentence. Upon approval of the application, the

Secretary shall publish information submitted under the two preceding sentences. The

Secretary shall, in consultation with the Director of the National Institutes of Health and with

representatives of the drug manufacturing industry, review and develop guidance, as

appropriate, on the inclusion of women and minorities in clinical trials required by clause (A).

(2) An application submitted under paragraph (1) for a drug for which the investigations

described in clause (A) of such paragraph and relied upon by the applicant for approval of the

application were not conducted by or for the applicant and for which the applicant has not

obtained a right of reference or use from the person by or for whom the investigations were

conducted shall also include—

(A) a certification, in the opinion of the applicant and to the best of his knowledge, with respect

to each patent which claims the drug for which such investigations were conducted or which

claims a use for such drug for which the applicant is seeking approval under this subsection

and for which information is required to be filed under paragraph (1) or subsection (c)—

(i) that such patent information has not been filed,

(ii) that such patent has expired,

(iii) of the date on which such patent will expire, or

(iv) that such patent is invalid or will not be infringed by the manufacture, use, or sale of the

new drug for which the application is submitted; and

(B) if with respect to the drug for which investigations described in paragraph (1)(A) were

conducted information was filed under paragraph (1) or subsection (c) for a method of use

patent which does not claim a use for which the applicant is seeking approval under this

subsection, a statement that the method of use patent does not claim such a use.

(3) Notice of opinion that patent is invalid or will not be infringed.--

(A) Agreement to give notice.--An applicant that makes a certification described in paragraph

(2)(A)(iv) shall include in the application a statement that the applicant will give notice as

required by this paragraph.

(B) Timing of notice.--An applicant that makes a certification described in paragraph (2)(A)(iv)

shall give notice as required under this paragraph--

(i) if the certification is in the application, not later than 20 days after the date of the postmark

on the notice with which the Secretary informs the applicant that the application has been filed;

or

(ii) if the certification is in an amendment or supplement to the application, at the time at which

the applicant submits the amendment or supplement, regardless of whether the applicant has

already given notice with respect to another such certification contained in the application or in

an amendment or supplement to the application.

(C) Recipients of notice.--An applicant required under this paragraph to give notice shall give

notice to--

(i) each owner of the patent that is the subject of the certification (or a representative of the

owner designated to receive such a notice); and

(ii) the holder of the approved application under this subsection for the drug that is claimed by

the patent or a use of which is claimed by the patent (or a representative of the holder

designated to receive such a notice).

(D) Contents of notice.--A notice required under this paragraph shall--

(i) state that an application that contains data from bioavailability or bioequivalence studies has

been submitted under this subsection for the drug with respect to which the certification is

made to obtain approval to engage in the commercial manufacture, use, or sale of the drug

before the expiration of the patent referred to in the certification; and

(ii) include a detailed statement of the factual and legal basis of the opinion of the applicant

that the patent is invalid or will not be infringed.

(4)(A) An applicant may not amend or supplement an application referred to in paragraph (2)

to seek approval of a drug that is a different drug than the drug identified in the application as

submitted to the Secretary.

(B) With respect to the drug for which such an application is submitted, nothing in this

subsection or subsection (c)(3) prohibits an applicant from amending or supplementing the

application to seek approval of a different strength.

( 5)(A) The Secretary shall issue guidance for the individuals who review applications

submitted under paragraph (1) or under section 351 of the Public Health Service Act, which

shall relate to promptness in conducting the review, technical excellence, lack of bias and

conflict of interest, and knowledge of regulatory and scientific standards, and which shall apply

equally to all individuals who review such applications.

(B) The Secretary shall meet with a sponsor of an investigation or an applicant for approval for

a drug under this subsection or section 351 of the Public Health Service Act if the sponsor or

applicant makes a reasonable written request for a meeting for the purpose of reaching

agreement on the design and size of clinical trials intended to form the primary basis of an

effectiveness claim. The sponsor or applicant shall provide information necessary for

discussion and agreement on the design and size of the clinical trials. Minutes of any such

meeting shall be prepared by the Secretary and made available to the sponsor or applicant

upon request.

(C) Any agreement regarding the parameters of the design and size of clinical trials of a new

drug under this paragraph that is reached between the Secretary and a sponsor or applicant

shall be reduced to writing and made part of the administrative record by the Secretary. Such

agreement shall not be changed after the testing begins, except—

(i) with the written agreement of the sponsor or applicant; or

(ii) pursuant to a decision, made in accordance with subparagraph (D) by the director of the

reviewing division, that a substantial scientific issue essential to determining the safety or

effectiveness of the drug has been identified after the testing has begun.

(D) A decision under subparagraph (C)(ii) by the director shall be in writing and the Secretary

shall provide to the sponsor or applicant an opportunity for a meeting at which the director and

the sponsor or applicant will be present and at which the director will document the scientific

issue involved.

(E) The written decisions of the reviewing division shall be binding upon, and may not directly

or indirectly be changed by, the field or compliance division personnel unless such field or

compliance division personnel demonstrate to the reviewing division why such decision should

be modified.

(F) No action by the reviewing division may be delayed because of the unavailability of

information from or action by field personnel unless the reviewing division determines that a

delay is necessary to assure the marketing of a safe and effective drug.

(G) For purposes of this paragraph, the reviewing division is the division responsible for the

review of an application for approval of a drug under this subsection or section 351 of the

Public Health Service Act (including all scientific and medical matters, chemistry,

manufacturing, and controls).

(c)(1) Within one hundred and eighty days after the filing of an application under subsection (b),

or such additional period as may be agreed upon by the Secretary and the applicant, the

Secretary shall either—

(A) approve the application if he then finds that none of the grounds for denying approval

specified in subsection (d) applies, or

(B) give the applicant notice of an opportunity for a hearing before the Secretary under

subsection (d) on the question whether such application is approvable. If the applicant elects

to accept the opportunity for hearing by written request within thirty days after such notice,

such hearing shall commence not more than ninety days after the expiration of such thirty days

unless the Secretary and the applicant otherwise agree. Any such hearing shall thereafter be

conducted on an expedited basis and the Secretary’s order thereon shall be issued within

ninety days after the date fixed by the Secretary for filing final briefs.

(2) If the patent information described in subsection (b) could not be filed with the submission

of an application under subsection (b) because the application was filed before the patent

information was required under subsection (b) or a patent was issued after the application was

approved under such subsection, the holder of an approved application shall file with the

Secretary, the patent number and the expiration date of any patent which claims the drug for

which the application was submitted or which claims a method of using such drug and with

respect to which a claim of patent infringement could reasonably be asserted if a person not

licensed by the owner engaged in the manufacture, use, or sale of the drug. If the holder of an

approved application could not file patent information under subsection (b) because it was not

required at the time the application was approved, the holder shall file such information under

this subsection not later than thirty days after the date of the enactment of this sentence 14,

and if the holder of an approved application could not file patent information under subsection

(b) because no patent had been issued when an application was filed or approved, the holder

shall file such information under this subsection not later than thirty days after the date the

patent involved is issued. Upon the submission of patent information under this subsection, the

Secretary shall publish it.

(3) The approval of an application filed under subsection (b) which contains a certification

required by paragraph (2) of such subsection shall be made effective on the last applicable

date determined by applying the following to each certification made under subsection

(b)(2)(A):

(A) If the applicant only made a certification described in clause (i) or (ii) of subsection (b)(2)(A)

or in both such clauses, the approval may be made effective immediately.

(B) If the applicant made a certification described in clause (iii) of subsection (b)(2)(A), the

approval may be made effective on the date certified under clause (iii).

(C) If the applicant made a certification described in clause (iv) of subsection (b)(2)(A), the

approval shall be made effective immediately unless, before the expiration of 45 days after the

date on which the notice described in subsection (b)(3) is received, an action is brought for

infringement of the patent that is the subject of the certification and for which information was

submitted to the Secretary under paragraph (2) or subsection (b)(1) before the date on which

the application (excluding an amendment or supplement to the application) was submitted. If

such an action is brought before the expiration of such days, the approval may be made

effective upon the expiration of the thirty-month period beginning on the date of the receipt of

the notice provided under subsection (b)(3) or such shorter or longer period as the court may

order because either party to the action failed to reasonably cooperate in expediting the action,

except that—

(i) if before the expiration of such period the district court decides that the patent is invalid or

not infringed (including any substantive determination that there is no cause of action for

patent infringement or invalidity), the approval shall be made effective on--

(I) the date on which the court enters judgment reflecting the decision; or

(II) the date of a settlement order or consent decree signed and entered by the court stating

that the patent that is the subject of the certification is invalid or not infringed;

(ii) if before the expiration of such period the district court decides that the patent has been

infringed--

(I) if the judgment of the district court is appealed, the approval shall be made effective on--

(aa) the date on which the court of appeals decides that the patent is invalid or not infringed

(including any substantive determination that there is no cause of action for patent

infringement or invalidity); or

(bb) the date of a settlement order or consent decree signed and entered by the court of

appeals stating that the patent that is the subject of the certification is invalid or not infringed;

or

(II) if the judgment of the district court is not appealed or is affirmed, the approval shall be

made effective on the date specified by the district court in a court order under section

271(e)(4)(A) of title 35, United States Code;

(iii) if before the expiration of such period the court grants a preliminary injunction prohibiting

the applicant from engaging in the commercial manufacture or sale of the drug until the court

decides the issues of patent validity and infringement and if the court decides that such patent

is invalid or not infringed, the approval shall be made effective as provided in clause (i); or

(iv) if before the expiration of such period the court grants a preliminary injunction prohibiting

the applicant from engaging in the commercial manufacture or sale of the drug until the court

decides the issues of patent validity and infringement and if the court decides that such patent

has been infringed, the approval shall be made effective as provided in clause (ii).

In such an action, each of the parties shall reasonably cooperate in expediting the action.

(D) Civil action to obtain patent certainty.—

(i) Declaratory judgment absent infringement action.--

(I) In general.--No action may be brought under section 2201 of title 28, United States Code,

by an applicant referred to in subsection (b)(2) for a declaratory judgment with respect to a

patent which is the subject of the certification referred to in subparagraph (C) unless--

(aa) the 45-day period referred to in such subparagraph has expired;

(bb) neither the owner of such patent nor the holder of the approved application under

subsection (b) for the drug that is claimed by the patent or a use of which is claimed by the

patent brought a civil action against the applicant for infringement of the patent before the

expiration of such period; and

(cc) in any case in which the notice provided under paragraph (2)(B) 15 relates to

noninfringement, the notice was accompanied by a document described in subclause (III).

(II) Filing of civil action.--If the conditions described in items (aa), (bb), and as applicable, (cc)

of subclause (I) have been met, the applicant referred to in such subclause may, in

accordance with section 2201 of title 28, United States Code, bring a civil action under such

section against the owner or holder referred to in such subclause (but not against any owner or

holder that has brought such a civil action against the applicant, unless that civil action was

dismissed without prejudice) for a declaratory judgment that the patent is invalid or will not be

infringed by the drug for which the applicant seeks approval, except that such civil action may

be brought for a declaratory judgment that the patent will not be infringed only in a case in

which the condition described in subclause (I)(cc) is applicable. A civil action referred to in this

subclause shall be brought in the judicial district where the defendant has its principal place of

business or a regular and established place of business.

(III) Offer of confidential access to application.--For purposes of subclause (I)(cc), the

document described in this subclause is a document providing an offer of confidential access

to the application that is in the custody of the applicant referred to in subsection (b)(2) for the

purpose of determining whether an action referred to in subparagraph (C) should be brought.

The document providing the offer of confidential access shall contain such restrictions as to

persons entitled to access, and on the use and disposition of any information accessed, as

would apply had a protective order been entered for the purpose of protecting trade secrets

and other confidential business information. A request for access to an application under an

offer of confidential access shall be considered acceptance of the offer of confidential access

with the restrictions as to persons entitled to access, and on the use and disposition of any

information accessed, contained in the offer of confidential access, and those restrictions and

other terms of the offer of confidential access shall be considered terms of an enforceable

contract. Any person provided an offer of confidential access shall review the application for

the sole and limited purpose of evaluating possible infringement of the patent that is the

subject of the certification under subsection (b)(2)(A)(iv) and for no other purpose, and may not

disclose information of no relevance to any issue of patent infringement to any person other

than a person provided an offer of confidential access. Further, the application may be

redacted by the applicant to remove any information of no relevance to any issue of patent

infringement.

(ii) Counterclaim to infringement action.—

(I) In general.--If an owner of the patent or the holder of the approved application under

subsection (b) for the drug that is claimed by the patent or a use of which is claimed by the

patent brings a patent infringement action against the applicant, the applicant may assert a

counterclaim seeking an order requiring the holder to correct or delete the patent information

submitted by the holder under subsection (b) or this subsection on the ground that the patent

does not claim either--

(aa) the drug for which the application was approved; or

(bb) an approved method of using the drug.

(II) No independent cause of action.--Subclause (I) does not authorize the assertion of a claim

described in subclause (I) in any civil action or proceeding other than a counterclaim described

in subclause (I).

(iii) No damages.--An applicant shall not be entitled to damages in a civil action under clause (i)

or a counterclaim under clause (ii).

( E)(i) If an application (other than an abbreviated new drug application) submitted under

subsection (b) for a drug, no active ingredient (including any ester or salt of the active

ingredient) of which has been approved in any other application under subsection (b), was

approved during the period beginning January 1, 1982, and ending on the date of the

enactment of this subsection 16, the Secretary may not make the approval of another

application for a drug for which the investigations described in clause (A) of subsection (b)(1)

and relied upon by the applicant for approval of the application were not conducted by or for

the applicant and for which the applicant has not obtained a right of reference or use from the

person by or for whom the investigations were conducted effective before the expiration of ten

years from the date of the approval of the application previously approved under subsection

(b).

(ii) If an application submitted under subsection (b) for a drug, no active ingredient (including

any ester or salt of the active ingredient) of which has been approved in any other application

under subsection (b), is approved after the date of the enactment of this clause, no application

which refers to the drug for which the subsection (b) application was submitted and for which

the investigations described in clause (A) of subsection (b)(1) and relied upon by the applicant

for approval of the application were not conducted by or for the applicant and for which the

applicant has not obtained a right of reference or use from the person by or for whom the

investigations were conducted may be submitted under subsection (b) before the expiration of

five years from the date of the approval of the application under subsection (b), except that

such an application may be submitted under subsection (b) after the expiration of four years

from the date of the approval of the subsection (b) application if it contains a certification of

patent invalidity or noninfringement described in clause (iv) of subsection (b)(2)(A). The

approval of such an application shall be made effective in accordance with this paragraph

except that, if an action for patent infringement is commenced during the one-year period

beginning forty-eight months after the date of the approval of the subsection (b) application,

the thirty-month period referred to in subparagraph (C) shall be extended by such amount of

time (if any) which is required for seven and one-half years to have elapsed from the date of

approval of the subsection (b) application.

(iii) If an application submitted under subsection (b) for a drug, which includes an active

ingredient (including any ester or salt of the active ingredient) that has been approved in

another application approved under subsection (b), is approved after the date of the

enactment of this clause and if such application contains reports of new clinical investigations

(other than bioavailability studies) essential to the approval of the application and conducted or

sponsored by the applicant, the Secretary may not make the approval of an application

submitted under subsection (b) for the conditions of approval of such drug in the approved

subsection (b) application effective before the expiration of three years from the date of the

approval of the application under subsection (b) if the investigations described in clause (A) of

subsection (b)(1) and relied upon by the applicant for approval of the application were not

conducted by or for the applicant and if the applicant has not obtained a right of reference or

use from the person by or for whom the investigations were conducted.

(iv) If a supplement to an application approved under subsection (b) is approved after the date

of enactment of this clause and the supplement contains reports of new clinical investigations

(other than bioavailabilty 17 studies) essential to the approval of the supplement and

conducted or sponsored by the person submitting the supplement, the Secretary may not

make the approval of an application submitted under subsection (b) for a change approved in

the supplement effective before the expiration of three years from the date of the approval of

the supplement under subsection (b) if the investigations described in clause (A) of subsection

(b)(1) and relied upon by the applicant for approval of the application were not conducted by or

for the applicant and if the applicant has not obtained a right of reference or use from the

person by or for whom the investigations were conducted.

(v) If an application (or supplement to an application) submitted under subsection (b) for a drug,

which includes an active ingredient (including any ester or salt of the active ingredient) that has

been approved in another application under subsection (b), was approved during the period

beginning January 1, 1982, and ending on the date of the enactment of this clause, the

Secretary may not make the approval of an application submitted under this subsection and for

which the investigations described in clause (A) of subsection (b)(1) and relied upon by the

applicant for approval of the application were not conducted by or for the applicant and for

which the applicant has not obtained a right of reference or use from the person by or for

whom the investigations were conducted and which refers to the drug for which the subsection

(b) application was submitted effective before the expiration of two years from the date of

enactment of this clause.

(4) A drug manufactured in a pilot or other small facility may be used to demonstrate the safety

and effectiveness of the drug and to obtain approval for the drug prior to manufacture of the

drug in a larger facility, unless the Secretary makes a determination that a full scale production

facility is necessary to ensure the safety or effectiveness of the drug.

(d) If the Secretary finds, after due notice to the applicant in accordance with subsection (c)

and giving him an opportunity for a hearing, in accordance with said subsection, that (1) the

investigations, reports of which are required to be submitted to the Secretary pursuant to

subsection (b), do not include adequate tests by all methods reasonably applicable to show

whether or not such drug is safe for use under the conditions prescribed, recommended, or

suggested in the proposed labeling thereof; (2) the results of such tests show that such drug is

unsafe for use under such conditions or do not show that such drug is safe for use under such

conditions; (3) the methods used in, and the facilities and controls used for, the manufacture,

processing, and packing of such drug are inadequate to preserve its identity, strength, quality,

and purity; (4) upon the basis of the information submitted to him as part of the application, or

upon the basis of any other information before him with respect to such drug, he has

insufficient information to determine whether such drug is safe for use under such conditions;

or (5) evaluated on the basis of the information submitted to him as part of the application and

any other information before him with respect to such drug, there is a lack of substantial

evidence that the drug will have the effect it purports or is represented to have under the

conditions of use prescribed, recommended, or suggested in the proposed labeling thereof; or

(6) the application failed to contain the patent information prescribed by subsection (b); or (7)

based on a fair evaluation of all material facts, such labeling is false or misleading in any

particular; he shall issue an order refusing to approve the application. If, after such notice and

opportunity for hearing, the Secretary finds that clauses (1) through (6) do not apply, he shall

issue an order approving the application. As used in this subsection and subsection (e), the

term ‘‘substantial evidence’’ means evidence consisting of adequate and well-controlled

investigations, including clinical investigations, by experts qualified by scientific training and

experience to evaluate the effectiveness of the drug involved, on the basis of which it could

fairly and responsibly be concluded by such experts that the drug will have the effect it

purports or is represented to have under the conditions of use prescribed, recommended, or

suggested in the labeling or proposed labeling thereof. If the Secretary determines, based on

relevant science, that data from one adequate and well-controlled clinical investigation and

confirmatory evidence (obtained prior to or after such investigation) are sufficient to establish

effectiveness, the Secretary may consider such data and evidence to constitute substantial

evidence for purposes of the preceding sentence.

(e) The Secretary shall, after due notice and opportunity for hearing to the applicant, withdraw

approval of an application with respect to any drug under this section if the Secretary finds (1)

that clinical or other experience, tests, or other scientific data show that such drug is unsafe for

use under the conditions of use upon the basis of which the application was approved; (2) that

new evidence of clinical experience, not contained in such application or not available to the

Secretary until after such application was approved, or tests by new methods, or tests by

methods not deemed reasonably applicable when such application was approved, evaluated

together with the evidence available to the Secretary when the application was approved,

shows that such drug is not shown to be safe for use under the conditions of use upon the

basis of which the application was approved; or (3) on the basis of new information before him

with respect to such drug, evaluated together with the evidence available to him when the

application was approved, that there is a lack of substantial evidence that the drug will have

the effect it purports or is represented to have under the conditions of use prescribed,

recommended, or suggested in the labeling thereof; or (4) the patent information prescribed by

subsection (c) was not filed within thirty days after the receipt of written notice from the

Secretary specifying the failure to file such information; or (5) that the application contains any

untrue statement of a material fact: Provided, That if the Secretary (or in his absence the

officer acting as Secretary) finds that there is an imminent hazard to the public health, he may

suspend the approval of such application immediately, and give the applicant prompt notice of

his action and afford the applicant the opportunity for an expedited hearing under this

subsection; but the authority conferred by this proviso to suspend the approval of an

application shall not be delegated. The Secretary may also, after due notice and opportunity

for hearing to the applicant, withdraw the approval of an application submitted under

subsection (b) or (j) with respect to any drug under this section if the Secretary finds (1) that

the applicant has failed to establish a system for maintaining required records, or has

repeatedly or deliberately failed to maintain such records or to make required reports, in

accordance with a regulation or order under subsection (k) or to comply with the notice

requirements of section 510(k)(2), or the applicant has refused to permit access to, or copying

or verification of, such records as required by paragraph (2) of such subsection; or (2) that on

the basis of new information before him, evaluated together with the evidence before him

when the application was approved, the methods used in, or the facilities and controls used for,

the manufacture, processing, and packing of such drug are inadequate to assure and preserve

its identity, strength, quality, and purity and were not made adequate within a reasonable time

after receipt of written notice from the Secretary specifying the matter complained of; or (3)

that on the basis of new information before him, evaluated together with the evidence before

him when the application was approved, the labeling of such drug, based on a fair evaluation

of all material facts, is false or misleading in any particular and was not corrected within a

reasonable time after receipt of written notice from the Secretary specifying the matter

complained of. Any order under this subsection shall state the findings upon which it is based.

(f) Whenever the Secretary finds that the facts so require, he shall revoke any previous order

under subsection (d) or (e) refusing, withdrawing, or suspending approval of an application

and shall approve such application or reinstate such approval, as may be appropriate.

(g) Orders of the Secretary issued under this section shall be served (1) in person by any

officer or employee of the Department designated by the Secretary or (2) by mailing the order

by registered mail or by certified mail addressed to the applicant or respondent at his

last-known address in the records of the Secretary.

(h) An appeal may be taken by the applicant from an order of the Secretary refusing or

withdrawing approval of an application under this section. Such appeal shall be taken by filing

in the United States court of appeals for the circuit wherein such applicant resides or has his

principal place of business, or in the United States Court of Appeals for the District of Columbia

Circuit, within sixty days after the entry of such order, a written petition praying that the order of

the Secretary be set aside. A copy of such petition shall be forthwith transmitted by the clerk of

the court to the Secretary, or any officer designated by him for that purpose, and thereupon the

Secretary shall certify and file in the court the record upon which the order complained of was

entered, as provided in section 2112 of title 28, United States Code. Upon the filing of such

petition such court shall have exclusive jurisdiction to affirm or set aside such order, except

that until the filing of the record the Secretary may modify or set aside his order. No objection

to the order of the Secretary shall be considered by the court unless such objection shall have

been urged before the Secretary or unless there were reasonable grounds for failure so to do.

The finding of the Secretary as to the facts, if supported by substantial evidence, shall be

conclusive. If any person shall apply to the court for leave to adduce additional evidence, and

shall show to the satisfaction of the court that such additional evidence is material and that

there were reasonable grounds for failure to adduce such evidence in the proceeding before

the Secretary, the court may order such additional evidence to be taken before the Secretary

and to be adduced upon the hearing in such manner and upon such terms and conditions as to

the court may seem proper. The Secretary may modify his findings as to the facts by reason of

the additional evidence so taken, and he shall file with the court such modified findings which,

if supported by substantial evidence, shall be conclusive, and his recommendation, if any, for

the setting aside of the original order. The judgment of the court affirming or setting aside any

such order of the Secretary shall be final, subject to review by the Supreme Court of the United

States upon certiorari or certification as provided in section 1254 of title 28 of the United States

Code. The commencement of proceedings under this subsection shall not, unless specifically

ordered by the court to the contrary, operate as a stay of the Secretary’s order.

(i)(1) The Secretary shall promulgate regulations for exempting from the operation of the

foregoing subsections of this section drugs intended solely for investigational use by experts

qualified by scientific training and experience to investigate the safety and effectiveness of

drugs. Such regulations may, within the discretion of the Secretary, among other conditions

relating to the protection of the public health, provide for conditioning such exemption upon—

(A) the submission to the Secretary, before any clinical testing of a new drug is undertaken, of

reports, by the manufacturer or the sponsor of the investigation of such drug, or preclinical

tests (including tests on animals) of such drug adequate to justify the proposed clinical testing;

(B) the manufacturer or the sponsor of the investigation of a new drug proposed to be

distributed to investigators for clinical testing obtaining a signed agreement from each of such

investigators that patients to whom the drug is administered will be under his personal

supervision, or under the supervision of investigators responsible to him, and that he will not

supply such drug to any other investigator, or to clinics, for administration to human beings;

(C) the establishment and maintenance of such records, and the making of such reports to the

Secretary, by the manufacturer or the sponsor of the investigation of such drug, of data

(including but not limited to analytical reports by investigators) obtained as the result of such

investigational use of such drug, as the Secretary finds will enable him to evaluate the safety

and effectiveness of such drug in the event of the filing of an application pursuant to

subsection (b) ; and

(D) 18 the submission to the Secretary by the manufacturer or the sponsor of the investigation

of a new drug of a statement of intent regarding whether the manufacturer or sponsor has

plans for assessing pediatric safety and efficacy.

(2) Subject to paragraph (3), a clinical investigation of a new drug may begin 30 days after the

Secretary has received from the manufacturer or sponsor of the investigation a submission

containing such information about the drug and the clinical investigation, including—

(A) information on design of the investigation and adequate reports of basic information,

certified by the applicant to be accurate reports, necessary to assess the safety of the drug for

use in clinical investigation; and

(B) adequate information on the chemistry and manufacturing of the drug, controls available

for the drug, and primary data tabulations from animal or human studies.

(3)(A) At any time, the Secretary may prohibit the sponsor of an investigation from conducting

the investigation (referred to in this paragraph as a ‘‘clinical hold’’) if the Secretary makes a

determination described in subparagraph (B). The Secretary shall specify the basis for the

clinical hold, including the specific information available to the Secretary which served as the

basis for such clinical hold, and confirm such determination in writing.

(B) For purposes of subparagraph (A), a determination described in this subparagraph with

respect to a clinical hold is that—

(i) the drug involved represents an unreasonable risk to the safety of the persons who are the

subjects of the clinical investigation, taking into account the qualifications of the clinical

investigators, information about the drug, the design of the clinical investigation, the condition

for which the drug is to be investigated, and the health status of the subjects involved; or

(ii) the clinical hold should be issued for such other reasons as the Secretary may by regulation

establish (including reasons established by regulation before the date of the enactment of the

Food and Drug Administration Modernization Act of 1997).

(C) Any written request to the Secretary from the sponsor of an investigation that a clinical hold

be removed shall receive a decision, in writing and specifying the reasons therefor, within 30

days after receipt of such request. Any such request shall include sufficient information to

support the removal of such clinical hold.

(4) Regulations under paragraph (1) shall provide that such exemption shall be conditioned

upon the manufacturer, or the sponsor of the investigation, requiring that experts using such

drugs for investigational purposes certify to such manufacturer or sponsor that they will inform

any human beings to whom such drugs, or any controls used in connection therewith, are

being administered, or their representatives, that such drugs are being used for investigational

purposes and will obtain the consent of such human beings or their representatives, except

where it is not feasible or it is contrary to the best interests of such human beings. Nothing in

this subsection shall be construed to require any clinical investigator to submit directly to the

Secretary reports on the investigational use of drugs.

(j)(1) Any person may file with the Secretary an abbreviated application for the approval of a

new drug.

(2)(A) An abbreviated application for a new drug shall contain—

(i) information to show that the conditions of use prescribed, recommended, or suggested in

the labeling proposed for the new drug have been previously approved for a drug listed under

paragraph (7) (hereinafter in this subsection referred to as a ‘‘listed drug’’);

(ii)(I) if the listed drug referred to in clause (i) has only one active ingredient, information to

show that the active ingredient of the new drug is the same as that of the listed drug;

(II) if the listed drug referred to in clause (i) has more than one active ingredient, information to

show that the active ingredients of the new drug are the same as those of the listed drug, or

(III) if the listed drug referred to in clause (i) has more than one active ingredient and if one of

the active ingredients of the new drug is different and the application is filed pursuant to the

approval of a petition filed under subparagraph (C), information to show that the other active

ingredients of the new drug are the same as the active ingredients of the listed drug,

information to show that the different active ingredient is an active ingredient of a listed drug or

of a drug which does not meet the requirements of section 201(p), and such other information

respecting the different active ingredient with respect to which the petition was filed as the

Secretary may require;

(iii) information to show that the route of administration, the dosage form, and the strength of

the new drug are the same as those of the listed drug referred to in clause (i), or, if the route of

administration, the dosage form, or the strength of the new drug is different and the application

is filed pursuant to the approval of a petition filed under subparagraph (C), such information

respecting the route of administration, dosage form, or strength with respect to which the

petition was filed as the Secretary may require;

(iv) information to show that the new drug is bioequivalent to the listed drug referred to in

clause (i), except that if the application is filed pursuant to the approval of a petition filed under

subparagraph (C), information to show that the active ingredients of the new drug are of the

same pharmacological or therapeutic class as those of the listed drug referred to in clause (i)

and the new drug can be expected to have the same therapeutic effect as the listed drug when

administered to patients for a condition of use referred to in clause (i);

(v) information to show that the labeling proposed for the new drug is the same as the labeling

approved for the listed drug referred to in clause (i) except for changes required because of

differences approved under a petition filed under subparagraph (C) or because the new drug

and the listed drug are produced or distributed by different manufacturers;

(vi) the items specified in clauses (B) through (F) of subsection (b)(1);

(vii) a certification, the opinion of the applicant and to the best of his knowledge, with respect to

each patent which claims the listed drug referred to in clause (i) or which claims a use for such

listed drug for which the applicant is seeking approval under this subsection and for which

information is required to be filed under subsection (b) or (c)—

(I) that such patent information has not been filed,

(II) that such patent has expired,

(III) of the date on which such patent will expire, or

(IV) that such patent is invalid or will not be infringed by the manufacture, , use, or sale of the

new drug for which the application is submitted; and

(viii) if with respect to the listed drug referred to in clause (i) information was filed under

subsection (b) or (c) for a method of use patent which does not claim a use for which the

applicant is seeking approval under this subsection, a statement that the method of use patent

does not claim such a use.

The Secretary may not require that an abbreviated application contain information in addition

to that required by clauses (i) through (viii).

(B) Notice of opinion that patent is invalid or will not be infringed.—

(i) Agreement to give notice.--An applicant that makes a certification described in

subparagraph (A)(vii)(IV) shall include in the application a statement that the applicant will give

notice as required by this subparagraph.

(ii) Timing of notice.--An applicant that makes a certification described in subparagraph

(A)(vii)(IV) shall give notice as required under this subparagraph—

(I) if the certification is in the application, not later than 20 days after the date of the postmark

on the notice with which the Secretary informs the applicant that the application has been filed;

or

(II) if the certification is in an amendment or supplement to the application, at the time at which

the applicant submits the amendment or supplement, regardless of whether the applicant has

already given notice with respect to another such certification contained in the application or in

an amendment or supplement to the application.

(iii) Recipients of notice.--An applicant required under this subparagraph to give notice shall

give notice to--

(I) each owner of the patent that is the subject of the certification (or a representative of the

owner designated to receive such a notice); and

(II) the holder of the approved application under subsection (b) for the drug that is claimed by

the patent or a use of which is claimed by the patent (or a representative of the holder

designated to receive such a notice).

(iv) Contents of notice.--A notice required under this subparagraph shall--

(I) state that an application that contains data from bioavailability or bioequivalence studies

has been submitted under this subsection for the drug with respect to which the certification is

made to obtain approval to engage in the commercial manufacture, use, or sale of the drug

before the expiration of the patent referred to in the certification; and

(II) include a detailed statement of the factual and legal basis of the opinion of the applicant

that the patent is invalid or will not be infringed.

(C) If a person wants to submit an abbreviated application for a new drug which has a different

active ingredient or whose route of administration, dosage form, or strength differ from that of a

listed drug, such person shall submit a petition to the Secretary seeking permission to file such

an application. The Secretary shall approve or disapprove a petition submitted under this

subparagraph within ninety days of the date the petition is submitted. The Secretary shall

approve such a petition unless the Secretary finds—

(i) that investigations must be conducted to show the safety and effectiveness of the drug or of

any of its active ingredients, the route of administration, the dosage form, or strength which

differ from the listed drug; or

(ii) that any drug with a different active ingredient may not be adequately evaluated for

approval as safe and effective on the basis of the information required to be submitted in an

abbreviated application.

(D)(i) An applicant may not amend or supplement an application to seek approval of a drug

referring to a different listed drug from the listed drug identified in the application as submitted

to the Secretary.

(ii) With respect to the drug for which an application is submitted, nothing in this subsection

prohibits an applicant from amending or supplementing the application to seek approval of a

different strength.

(iii) Within 60 days after the date of the enactment of the Medicare Prescription Drug,

Improvement, and Modernization Act of 2003, 19 the Secretary shall issue guidance defining

the term `listed drug' for purposes of this subparagraph.

(3)(A) The Secretary shall issue guidance for the individuals who review applications

submitted under paragraph (1), which shall relate to promptness in conducting the review,

technical excellence, lack of bias and conflict of interest, and knowledge of regulatory and

scientific standards, and which shall apply equally to all individuals who review such

applications.

(B) The Secretary shall meet with a sponsor of an investigation or an applicant for approval for

a drug under this subsection if the sponsor or applicant makes a reasonable written request for

a meeting for the purpose of reaching agreement on the design and size of bioavailability and

bioequivalence studies needed for approval of such application. The sponsor or applicant shall

provide information necessary for discussion and agreement on the design and size of such

studies. Minutes of any such meeting shall be prepared by the Secretary and made available

to the sponsor or applicant.

(C) Any agreement regarding the parameters of design and size of bioavailability and

bioequivalence studies of a drug under this paragraph that is reached between the Secretary

and a sponsor or applicant shall be reduced to writing and made part of the administrative

record by the Secretary. Such agreement shall not be changed after the testing begins,

except—

(i) with the written agreement of the sponsor or applicant; or

(ii) pursuant to a decision, made in accordance with subparagraph (D) by the director of the

reviewing division, that a substantial scientific issue essential to determining the safety or

effectiveness of the drug has been identified after the testing has begun.

(D) A decision under subparagraph (C)(ii) by the director shall be in writing and the Secretary

shall provide to the sponsor or applicant an opportunity for a meeting at which the director and

the sponsor or applicant will be present and at which the director will document the scientific

issue involved.

(E) The written decisions of the reviewing division shall be binding upon, and may not directly

or indirectly be changed by, the field or compliance office personnel unless such field or

compliance office personnel demonstrate to the reviewing division why such decision should

be modified.

(F) No action by the reviewing division may be delayed because of the unavailability of

information from or action by field personnel unless the reviewing division determines that a

delay is necessary to assure the marketing of a safe and effective drug.

(G) For purposes of this paragraph, the reviewing division is the division responsible for the

review of an application for approval of a drug under this subsection (including scientific

matters, chemistry, manufacturing, and controls).

(4) Subject to paragraph (5), the Secretary shall approve an application for a drug unless the

Secretary finds—

(A) the methods used in, or the facilities and controls used for, the manufacture, processing,

and packing of the drug are inadequate to assure and preserve its identity, strength, quality,

and purity;

(B) information submitted with the application is insufficient to show that each of the proposed

conditions of use have been previously approved for the listed drug referred to in the

application;

(C)(i) if the listed drug has only one active ingredient, information submitted with the

application is insufficient to show that the active ingredient is the same as that of the listed

drug;

(ii) if the listed drug has more than one active ingredient, information submitted with the

application is insufficient to show that the active ingredients are the same as the active

ingredients of the listed drug, or

(iii) if the listed drug has more than one active ingredient and if the application is for a drug

which has an active ingredient different from the listed drug, information submitted with the

application is insufficient to show—

(I) that the other active ingredients are the same as the active ingredients of the listed drug, or

(II) that the different active ingredient is an active ingredient of a listed drug or a drug which

does not meet the requirements of section 201(p). or no petition to file an application for the

drug with the different ingredient was approved under paragraph (2)(C);

(D)(i) if the application is for a drug whose route of administration, dosage form, or strength of

the drug is the same as the route of administration, dosage form, or strength of the listed drug

referred to in the application, information submitted in the application is insufficient to show

that the route of administration, dosage form, or strength is the same as that of the listed drug,

or

(ii) if the application is for a drug whose route of administration, dosage form, or strength of the

drug is different from that of the listed drug referred to in the application, no petition to file an

application for the drug with the different route of administration, dosage form, or strength was

approved under paragraph (2)(C);

(E) if the application was filed pursuant to the approval of a petition under paragraph (2)(C),

the application did not contain the information required by the Secretary respecting the active

ingredient, route of administration, dosage form, or strength which is not the same;

(F) information submitted in the application is insufficient to show that the drug is bioequivalent

to the listed drug referred to in the application or, if the application was filed pursuant to a

petition approved under paragraph (2)(C) information submitted in the application is

insufficient to show that the active ingredients of the new drug are of the same

pharmacological or therapeutic class as those of the listed drug referred to in paragraph

(2)(A)(i) and that the new drug can be expected to have the same therapeutic effect as the

listed drug when administered to patients for a condition of use referred to in such paragraph;

(G) information submitted in the application is insufficient to show that the labeling proposed

for the drug is the same as the labeling approved for the listed drug referred to in the

application except for changes required because of differences approved under a petition filed

under paragraph (2)(C) or because the drug and the listed drug are produced or distributed by

different manufacturers;

(H) information submitted in the application or any other information available to the Secretary

shows that (i) the inactive ingredients of the drug are unsafe for use under the conditions

prescribed, recommended, or suggested in the labeling proposed for the drug, or (ii) the

composition of the drug is unsafe under such conditions because of the type or quantity of

inactive ingredients included or the manner in which the inactive ingredients are included;

(I) the approval under subsection (c) of the listed drug referred to in the application under this

subsection has been withdrawn or suspended for grounds described in the first sentence of

subsection (e), the Secretary has published a notice of opportunity for hearing to withdraw

approval of the listed drug under subsection (c) for grounds described in the first sentence of

subsection (e), the approval under this subsection of the listed drug referred to in the

application under this subsection has been withdrawn or suspended under paragraph (6), or

the Secretary has determined that the listed drug has been withdrawn from sale for safety or

effectiveness reasons;

(J) the application does not meet any other requirement of paragraph (2)(A); or

(K) the application contains an untrue statement of material fact.

(5)(A) Within one hundred and eighty days of the initial receipt of an application under

paragraph (2) or within such additional period as may be agreed upon by the Secretary and

the applicant, the Secretary shall approve or disapprove the application.

(B) The approval of an application submitted under paragraph (2) shall be made effective on

the last applicable date determined by applying the following to each certification made under

paragraph (2)(A)(vii):

(i) If the applicant only made a certification described in subclause (I) or (II) of paragraph

(2)(A)(vii) or in both such subclauses, the approval may be made effective immediately.

(ii) If the applicant made a certification described in subclause (III) of paragraph (2)(A)(vii), the

approval may be made effective on the date certified under subclause (III).

(iii) If the applicant made a certification described in subclause (IV) of paragraph (2)(A)(vii), the

approval shall be made effective immediately unless, before the expiration of 45 days after the

date on which the notice described in paragraph (2)(B) is received, an action is brought for

infringement of the patent that is the subject of the certification and for which information was

submitted to the Secretary under subsection (b)(1) or (c)(2) before the date on which the

application (excluding an amendment or supplement to the application), which the Secretary

later determines to be substantially complete, was submitted. If such an action is brought

before the expiration of such days, the approval shall be made effective upon the expiration of

the thirty-month period beginning on the date of the receipt of the notice provided under

paragraph (2)(B)(i) or such shorter or longer period as the court may order because either

party to the action failed to reasonably cooperate in expediting the action, except that—

(I) if before the expiration of such period the district court decides that the patent is invalid or

not infringed (including any substantive determination that there is no cause of action for

patent infringement or invalidity), the approval shall be made effective on--

(aa) the date on which the court enters judgment reflecting the decision; or

(bb) the date of a settlement order or consent decree signed and entered by the court stating

that the patent that is the subject of the certification is invalid or not infringed;

(II) if before the expiration of such period the district court decides that the patent has been

infringed--

(aa) if the judgment of the district court is appealed, the approval shall be made effective on--

(AA) the date on which the court of appeals decides that the patent is invalid or not infringed

(including any substantive determination that there is no cause of action for patent

infringement or invalidity); or

(BB) the date of a settlement order or consent decree signed and entered by the court of

appeals stating that the patent that is the subject of the certification is invalid or not infringed;

or

(bb) if the judgment of the district court is not appealed or is affirmed, the approval shall be

made effective on the date specified by the district court in a court order under section

271(e)(4)(A) of title 35, United States Code;

(III) if before the expiration of such period the court grants a preliminary injunction prohibiting

the applicant from engaging in the commercial manufacture or sale of the drug until the court

decides the issues of patent validity and infringement and if the court decides that such patent

is invalid or not infringed, the approval shall be made effective as provided in subclause (I); or

(IV) if before the expiration of such period the court grants a preliminary injunction prohibiting

the applicant from engaging in the commercial manufacture or sale of the drug until the court

decides the issues of patent validity and infringement and if the court decides that such patent

has been infringed, the approval shall be made effective as provided in subclause (II).

In such an action, each of the parties shall reasonably cooperate in expediting the action.

(iv) 180-day exclusivity period.--

(I) Effectiveness of application.--Subject to subparagraph (D), if the application contains a

certification described in paragraph (2)(A)(vii)(IV) and is for a drug for which a first applicant

has submitted an application containing such a certification, the application shall be made

effective on the date that is 180 days after the date of the first commercial marketing of the

drug (including the commercial marketing of the listed drug) by any first applicant.

(II) Definitions.--In this paragraph:

(aa) 180-day exclusivity period.--The term `180-day exclusivity period' means the 180-day

period ending on the day before the date on which an application submitted by an applicant

other than a first applicant could become effective under this clause.

(bb) First applicant.--As used in this subsection, the term `first applicant' means an applicant

that, on the first day on which a substantially complete application containing a certification

described in paragraph (2)(A)(vii)(IV) is submitted for approval of a drug, submits a

substantially complete application that contains and lawfully maintains a certification described

in paragraph (2)(A)(vii)(IV) for the drug.

(cc) Substantially complete application.--As used in this subsection, the term `substantially

complete application' means an application under this subsection that on its face is sufficiently

complete to permit a substantive review and contains all the information required by paragraph

(2)(A).

(dd) Tentative approval.--

(AA) In general.--The term `tentative approval' means notification to an applicant by the

Secretary that an application under this subsection meets the requirements of paragraph

(2)(A), but cannot receive effective approval because the application does not meet the

requirements of this subparagraph, there is a period of exclusivity for the listed drug under

subparagraph (F) or section 505A, or there is a 7-year period of exclusivity for the listed drug

under section 527.

(BB) Limitation.--A drug that is granted tentative approval by the Secretary is not an approved

drug and shall not have an effective approval until the Secretary issues an approval after any

necessary additional review of the application.

(C) Civil action to obtain patent certainty.--

(i) Declaratory judgment absent infringement action.--

(I) In general.--No action may be brought under section 2201 of title 28, United States Code,

by an applicant under paragraph (2) for a declaratory judgment with respect to a patent which

is the subject of the certification referred to in subparagraph (B)(iii) unless--

(aa) the 45-day period referred to in such subparagraph has expired;

(bb) neither the owner of such patent nor the holder of the approved application under

subsection (b) for the drug that is claimed by the patent or a use of which is claimed by the

patent brought a civil action against the applicant for infringement of the patent before the

expiration of such period; and

(cc) in any case in which the notice provided under paragraph (2)(B) relates to

noninfringement, the notice was accompanied by a document described in subclause (III).

(II) Filing of civil action.--If the conditions described in items (aa), (bb), and as applicable, (cc)

of subclause (I) have been met, the applicant referred to in such subclause may, in

accordance with section 2201 of title 28, United States Code, bring a civil action under such

section against the owner or holder referred to in such subclause (but not against any owner or

holder that has brought such a civil action against the applicant, unless that civil action was

dismissed without prejudice) for a declaratory judgment that the patent is invalid or will not be

infringed by the drug for which the applicant seeks approval, except that such civil action may

be brought for a declaratory judgment that the patent will not be infringed only in a case in

which the condition described in subclause (I)(cc) is applicable. A civil action referred to in this

subclause shall be brought in the judicial district where the defendant has its principal place of

business or a regular and established place of business.

(III) Offer of confidential access to application.--For purposes of subclause (I)(cc), the

document described in this subclause is a document providing an offer of confidential access

to the application that is in the custody of the applicant under paragraph (2) for the purpose of

determining whether an action referred to in subparagraph (B)(iii) should be brought. The

document providing the offer of confidential access shall contain such restrictions as to

persons entitled to access, and on the use and disposition of any information accessed, as

would apply had a protective order been entered for the purpose of protecting trade secrets

and other confidential business information. A request for access to an application under an

offer of confidential access shall be considered acceptance of the offer of confidential access

with the restrictions as to persons entitled to access, and on the use and disposition of any

information accessed, contained in the offer of confidential access, and those restrictions and

other terms of the offer of confidential access shall be considered terms of an enforceable

contract. Any person provided an offer of confidential access shall review the application for

the sole and limited purpose of evaluating possible infringement of the patent that is the

subject of the certification under paragraph (2)(A)(vii)(IV) and for no other purpose, and may

not disclose information of no relevance to any issue of patent infringement to any person

other than a person provided an offer of confidential access. Further, the application may be

redacted by the applicant to remove any information of no relevance to any issue of patent

infringement.

(ii) Counterclaim to infringement action.--

(I) In general.--If an owner of the patent or the holder of the approved application under

subsection (b) for the drug that is claimed by the patent or a use of which is claimed by the

patent brings a patent infringement action against the applicant, the applicant may assert a

counterclaim seeking an order requiring the holder to correct or delete the patent information

submitted by the holder under subsection (b) or (c) on the ground that the patent does not

claim either--

(aa) the drug for which the application was approved; or

(bb) an approved method of using the drug.

(II) No independent cause of action.--Subclause (I) does not authorize the assertion of a claim

described in subclause (I) in any civil action or proceeding other than a counterclaim described

in subclause (I).

(iii) No damages.--An applicant shall not be entitled to damages in a civil action under clause (i)

or a counterclaim under clause (ii).

(D) Forfeiture of 180-day exclusivity period.--

(i) Definition of forfeiture event.--In this subparagraph, the term `forfeiture event', with respect

to an application under this subsection, means the occurrence of any of the following:

(I) Failure to market.--The first applicant fails to market the drug by the later of--

(aa) the earlier of the date that is--

(AA) 75 days after the date on which the approval of the application of the first applicant is

made effective under subparagraph (B)(iii); or

(BB) 30 months after the date of submission of the application of the first applicant; or

(bb) with respect to the first applicant or any other applicant (which other applicant has

received tentative approval), the date that is 75 days after the date as of which, as to each of

the patents with respect to which the first applicant submitted and lawfully maintained a

certification qualifying the first applicant for the 180-day exclusivity period under subparagraph

(B)(iv), at least 1 of the following has occurred:

(AA) In an infringement action brought against that applicant with respect to the patent or in a

declaratory judgment action brought by that applicant with respect to the patent, a court enters

a final decision from which no appeal (other than a petition to the Supreme Court for a writ of

certiorari) has been or can be taken that the patent is invalid or not infringed.

(BB) In an infringement action or a declaratory judgment action described in subitem (AA), a

court signs a settlement order or consent decree that enters a final judgment that includes a

finding that the patent is invalid or not infringed.

(CC) The patent information submitted under subsection (b) or (c) is withdrawn by the holder

of the application approved under subsection (b).

(II) Withdrawal of application.--The first applicant withdraws the application or the Secretary

considers the application to have been withdrawn as a result of a determination by the

Secretary that the application does not meet the requirements for approval under paragraph

(4).

(III) Amendment of certification.--The first applicant amends or withdraws the certification for

all of the patents with respect to which that applicant submitted a certification qualifying the

applicant for the 180-day exclusivity period.

(IV) Failure to obtain tentative approval.--The first applicant fails to obtain tentative approval of

the application within 30 months after the date on which the application is filed, unless the

failure is caused by a change in or a review of the requirements for approval of the application

imposed after the date on which the application is filed.

(V) Agreement with another applicant, the listed drug application holder, or a patent

owner.--The first applicant enters into an agreement with another applicant under this

subsection for the drug, the holder of the application for the listed drug, or an owner of the

patent that is the subject of the certification under paragraph (2)(A)(vii)(IV), the Federal Trade

Commission or the Attorney General files a complaint, and there is a final decision of the

Federal Trade Commission or the court with regard to the complaint from which no appeal

(other than a petition to the Supreme Court for a writ of certiorari) has been or can be taken

that the agreement has violated the antitrust laws (as defined in section 1 of the Clayton Act

(15 U.S.C. 12), except that the term includes section 5 of the Federal Trade Commission Act

(15 U.S.C. 45) to the extent that that section applies to unfair methods of competition).

(VI) Expiration of all patents.--All of the patents as to which the applicant submitted a

certification qualifying it for the 180-day exclusivity period have expired.

(ii) Forfeiture.--The 180-day exclusivity period described in subparagraph (B)(iv) shall be

forfeited by a first applicant if a forfeiture event occurs with respect to that first applicant.

(iii) Subsequent applicant.--If all first applicants forfeit the 180-day exclusivity period under

clause (ii)--

(I) approval of any application containing a certification described in paragraph (2)(A)(vii)(IV)

shall be made effective in accordance with subparagraph (B)(iii); and

(II) no applicant shall be eligible for a 180-day exclusivity period.

( E) If the Secretary decides to disapprove an application, the Secretary shall give the

applicant notice of an opportunity for a hearing before the Secretary on the question of

whether such application is approvable. If the applicant elects to accept the opportunity for

hearing by written request within thirty days after such notice, such hearing shall commence

not more than ninety days after the expiration of such thirty days unless the Secretary and the

applicant otherwise agree. Any such hearing shall thereafter be conducted on an expedited

basis and the Secretary’s order thereon shall be issued within ninety days after the date fixed

by the Secretary for filing final briefs.

( F)(i) If an application (other than an abbreviated new drug application) submitted under

subsection (b) for a drug, no active ingredient (including any ester or salt of the active

ingredient) of which has been approved in any other application under subsection (b), was

approved during the period beginning January 1, 1982, and ending on the date of the

enactment of this subsection 20 , the Secretary may not make the approval of an application

submitted under this subsection which refers to the drug for which the subsection (b)

application was submitted effective before the expiration of ten years from the date of the

approval of the application under subsection (b).

(ii) If an application submitted under subsection (b) for a drug, no active ingredient (including

any ester or salt of the active ingredient) of which has been approved in any other application

under subsection (b), is approved after the date of the enactment of this subsection, no

application may be submitted under this subsection which refers to the drug for which the

subsection (b) application was submitted before the expiration of five years from the date of

the approval of the application under subsection (b), except that such an application may be

submitted under this subsection after the expiration of four years from the date of the approval

of the subsection (b) application if it contains a certification of patent invalidity or

noninfringement described in subclause (IV) of paragraph (2)(A)(vii). The approval of such an

application shall be made effective in accordance with subparagraph (B) except that, if an

action for patent infringement is commenced during the one-year period beginning forty-eight

months after the date of the approval of the subsection (b) application, the thirty-month period

referred to in subparagraph (B)(iii) shall be extended by such amount of time (if any) which is

required for seven and one-half years to have elapsed from the date of approval of the

subsection (b) application.

(iii) If an application submitted under subsection (b) for a drug, which includes an active

ingredient (including any ester or salt of the active ingredient) that has been approved in

another application approved under subsection (b), is approved after the date of enactment of

this subsection 20 and if such application contains reports of new clinical investigations (other

than bioavailability studies) essential to the approval of the application and conducted or

sponsored by the applicant, the Secretary may not make the approval of an application

submitted under this subsection for the conditions of approval of such drug in the subsection (b)

application effective before the expiration of three years from the date of the approval of the

application under subsection (b) for such drug.

(iv) If a supplement to an application approved under subsection (b) is approved after the date

of enactment of this subsection 20 and the supplement contains reports of new clinical

investigations (other than bioavailability studies) essential to the approval of the supplement

and conducted or sponsored by the person submitting the supplement, the Secretary may not

make the approval of an application submitted under this subsection for a change approved in

the supplement effective before the expiration of three years from the date of the approval of

the supplement under subsection (b).

(v) If an application (or supplement to an application) submitted under subsection (b) for a drug,

which includes an active ingredient (including any ester or salt of the active ingredient) that has

been approved in another application under subsection (b), was approved during the period

beginning January 1, 1982, and ending on the date of the enactment of this subsection 21 , the

Secretary may not make the approval of an application submitted under this subsection which

refers to the drug for which the subsection (b) application was submitted or which refers to a

change approved in a supplement to the subsection (b) application effective before the

expiration of two years from the date of enactment of this subsection 21.

(6) If a drug approved under this subsection refers in its approved application to a drug the

approval of which was withdrawn or suspended for grounds described in the first sentence of

subsection (e) or was withdrawn or suspended under this paragraph or which, as determined

by the Secretary, has been withdrawn from sale for safety or effectiveness reasons, the

approval of the drug under this subsection shall be withdrawn or suspended—

(A) for the same period as the withdrawal or suspension under subsection (e) or this

paragraph, or

(B) if the listed drug has been withdrawn from sale, for the period of withdrawal from sale or, if

earlier, the period ending on the date the Secretary determines that the withdrawal from sale is

not for safety or effectiveness reasons.

(7)(A)(i) Within sixty days of the date of the enactment of this subsection 22 , the Secretary

shall publish and make available to the public—

(I) a list in alphabetical order of the official and proprietary name of each drug which has been

approved for safety and effectiveness under subsection (c) before the date of the enactment of

this subsection 21;

(II) the date of approval if the drug is approved after 1981 and the number of the application

which was approved; and

(III) whether in vitro or in vivo bioequivalence studies, or both such studies, are required for

applications filed under this subsection which will refer to the drug published.

(ii) Every thirty days after the publication of the first list under clause (i) the Secretary shall

revise the list to include each drug which has been approved for safety and effectiveness

under subsection (c) or approved under this subsection during the thirty day period.

(iii) When patent information submitted under subsection (b) or (c) respecting a drug included

on the list is to be published by the Secretary, the Secretary shall, in revisions made under

clause (ii), include such information for such drug.

(B) A drug approved for safety and effectiveness under subsection (c) or approved under this

subsection shall, for purposes of this subsection, be considered to have been published under

subparagraph (A) on the date of its approval or the date of enactment 23 , whichever is later.

(C) If the approval of a drug was withdrawn or suspended for grounds described in the first

sentence of subsection (e) or was withdrawn or suspended under paragraph (6) or if the

Secretary determines that a drug has been withdrawn from sale for safety or effectiveness

reasons, it may not be published in the list under subparagraph (A) or, if the withdrawal or

suspension occurred after its publication in such list, it shall be immediately removed from

such list—

(i) for the same period as the withdrawal or suspension under subsection (e) or paragraph (6),

or

(ii) if the listed drug has been withdrawn from sale, for the period of withdrawal from sale or, if

earlier, the period ending on the date the Secretary determines that the withdrawal from sale is

not for safety or effectiveness reasons.

A notice of the removal shall be published in the Federal Register.

(8) 24 For purposes of this subsection:

(A)(i) The term `bioavailability' means the rate and extent to which the active ingredient or

therapeutic ingredient is absorbed from a drug and becomes available at the site of drug

action.

(ii) For a drug that is not intended to be absorbed into the bloodstream, the Secretary may

assess bioavailability by scientifically valid measurements intended to reflect the rate and

extent to which the active ingredient or therapeutic ingredient becomes available at the site of

drug action.

(B) A drug shall be considered to be bioequivalent to a listed drug if—

(i) the rate and extent of absorption of the drug do not show a significant difference from the

rate and extent of absorption of the listed drug when administered at the same molar dose of

the therapeutic ingredient under similar experimental conditions in either a single dose or

multiple doses; or

(ii) the extent of absorption of the drug does not show a significant difference from the extent of

absorption of the listed drug when administered at the same molar dose of the therapeutic

ingredient under similar experimental conditions in either a single dose or multiple doses and

the difference from the listed drug in the rate of absorption of the drug is intentional, is reflected

in its proposed labeling, is not essential to the attainment of effective body drug concentrations

on chronic use, and is considered medically insignificant for the drug.

(C) For a drug that is not intended to be absorbed into the bloodstream, the Secretary may

establish alternative, scientifically valid methods to show bioequivalence if the alternative

methods are expected to detect a significant difference between the drug and the listed drug in

safety and therapeutic effect.

(9) The Secretary shall, with respect to each application submitted under this subsection,

maintain a record of—

(A) the name of the applicant,

(B) the name of the drug covered by the application,

(C) the name of each person to whom the review of the chemistry of the application was

assigned and the date of such assignment, and

(D) the name of each person to whom the bioequivalence review for such application was

assigned and the date of such assignment.

The information the Secretary is required to maintain under this paragraph with respect to an

application submitted under this subsection shall be made available to the public after the

approval of such application.

(k)(1) In the case of any drug for which an approval of an application filed under subsection (b)

or (j) is in effect, the applicant shall establish and maintain such records, and make such

reports to the Secretary, of data relating to clinical experience and other data or information,

received or otherwise obtained by such applicant with respect to such drug, as the Secretary

may by general regulation, or by order with respect to such application, prescribe on the basis

of a finding that such records and reports are necessary in order to enable the Secretary to

determine, or facilitate a determination, whether there is or may be ground for invoking

subsection (e) of this section. Regulations and orders issued under this subsection and under

subsection (i) shall have due regard for the professional ethics of the medical profession and

the interests of patients and shall provide, where the Secretary deems it to be appropriate, for

the examination, upon request, by the persons to whom such regulations or orders are

applicable, of similar information received or otherwise obtained by the Secretary.

(2) Every person required under this section to maintain records, and every person in charge

or custody thereof, shall, upon request of an officer or employee designated by the Secretary,

permit such officer or employee at all reasonable times to have access to and copy and verify

such records.

(l) Safety and effectiveness data and information which has been submitted in an application

under subsection (b) for a drug and which has not previously been disclosed to the public shall

be made available to the public, upon request, unless extraordinary circumstances are

shown—

(1) if no work is being or will be undertaken to have the application approved,

(2) if the Secretary has determined that the application is not approvable and all legal appeals

have been exhausted,

(3) if approval of the application under subsection (c) is withdrawn and all legal appeals have

been exhausted,

(4) if the Secretary has determined that such drug is not a new drug, or

(5) upon the effective date of the approval of the first application under subsection (j) which

refers to such drug or upon the date upon which the approval of an application under

subsection (j) which refers to such drug could be made effective if such an application had

been submitted.

(m) For purposes of this section, the term ‘‘patent’’ means a patent issued by the United States

Patent and Trademark Office.

(n)(1) For the purpose of providing expert scientific advice and recommendations to the

Secretary regarding a clinical investigation of a drug or the approval for marketing of a drug

under section 505 or section 351 of the Public Health Service Act, the Secretary shall establish

panels of experts or use panels of experts established before the date of enactment of the

Food and Drug Administration Modernization Act of 1997, or both.

(2) The Secretary may delegate the appointment and oversight authority granted under section

904 to a director of a center or successor entity within the Food and Drug Administration.

(3) The Secretary shall make appointments to each panel established under paragraph (1) so

that each panel shall consist of—

(A) members who are qualified by training and experience to evaluate the safety and

effectiveness of the drugs to be referred to the panel and who, to the extent feasible, possess

skill and experience in the development, manufacture, or utilization of such drugs;

(B) members with diverse expertise in such fields as clinical and administrative medicine,

pharmacy, pharmacology, pharmacoeconomics, biological and physical sciences, and other

related professions;

(C) a representative of consumer interests, and a representative of interests of the drug

manufacturing industry not directly affected by the matter to be brought before the panel; and

(D) two or more members who are specialists or have other expertise in the particular disease

or condition for which the drug under review is proposed to be indicated.

Scientific, trade, and consumer organizations shall be afforded an opportunity to nominate

individuals for appointment to the panels. No individual who is in the regular full-time employ of

the United States and engaged in the administration of this Act may be a voting member of any

panel. The Secretary shall designate one of the members of each panel to serve as chairman

thereof.

(4) Each member of a panel shall publicly disclose all conflicts of interest that member may

have with the work to be undertaken by the panel. No member of a panel may vote on any

matter where the member or the immediate family of such member could gain financially from

the advice given to the Secretary. The Secretary may grant a waiver of any conflict of interest

requirement upon public disclosure of such conflict of interest if such waiver is necessary to

afford the panel essential expertise, except that the Secretary may not grant a waiver for a

member of a panel when the member’s own scientific work is involved.

(5) The Secretary shall, as appropriate, provide education and training to each new panel

member before such member participates in a panel’s activities, including education regarding

requirements under this Act and related regulations of the Secretary, and the administrative

processes and procedures related to panel meetings.

(6) Panel members (other than officers or employees of the United States), while attending

meetings or conferences of a panel or otherwise engaged in its business, shall be entitled to

receive compensation for each day so engaged, including traveltime, at rates to be fixed by the

Secretary, but not to exceed the daily equivalent of the rate in effect for positions classified

above grade GS–15 of the General Schedule. While serving away from their homes or regular

places of business, panel members may be allowed travel expenses (including per diem in lieu

of subsistence) as authorized by section 5703 of title 5, United States Code, for persons in the

Government service employed intermittently.

(7) The Secretary shall ensure that scientific advisory panels meet regularly and at appropriate

intervals so that any matter to be reviewed by such a panel can be presented to the panel not

more than 60 days after the matter is ready for such review. Meetings of the panel may be held

using electronic communication to convene the meetings.

(8) Within 90 days after a scientific advisory panel makes recommendations on any matter

under its review, the Food and Drug Administration official responsible for the matter shall

review the conclusions and recommendations of the panel, and notify the affected persons of

the final decision on the matter, or of the reasons that no such decision has been reached.

Each such final decision shall be documented including the rationale for the decision.

SEC. 505A. [ 21 U.S.C. 355a] PEDIATRIC STUDIES OF DRUGS. 25

( a) DEFINITIONS.—As used in this section, the term ‘‘pediatric studies’’ or ‘‘studies’’ means at

least one clinical investigation (that, at the Secretary’s discretion, may include pharmacokinetic

studies) in pediatric age groups (including neonates in appropriate cases) in which a drug is

anticipated to be used.

( b) MARKET EXCLUSIVITY FOR NEW DRUGS.—If, prior to approval of an application that is

submitted under section 505(b)(1), the Secretary determines that information relating to the

use of a new drug in the pediatric population may produce health benefits in that population,

the Secretary makes a written request for pediatric studies (which shall include a timeframe for

completing such studies), and such studies are completed within any such timeframe and the

reports thereof submitted in accordance with subsection (d)(2) or accepted in accordance with

subsection (d)(3)—

(1)(A)(i) the period referred to in subsection (c)(3)(D)(ii) of section 505, and in subsection

(j)(5)(F)(ii)of such section, is deemed to be five years and six months rather than five years,

and the references in subsections (c)(3)(D)(ii) and (j)(5)(F)(ii) of such section to four years, to

forty-eight months, and to seven and one-half years are deemed to be four and one-half years,

fifty-four months, and eight years, respectively; or

(ii) the period referred to in clauses (iii) and (iv) of subsection (c)(3)(D) of such section, and in

clauses (iii) and (iv) of subsection (j)(5)(F) of such section, is deemed to be three years and six

months rather than three years; and

(B) if the drug is designated under section 526 for a rare disease or condition, the period

referred to in section 527(a) is deemed to be seven years and six months rather than seven

years; and

(2)(A) if the drug is the subject of—

(i) a listed patent for which a certification has been submitted under subsection (b)(2)(A)(ii) or

(j)(2)(A)(vii)(II) of section 505 and for which pediatric studies were submitted prior to the

expiration of the patent (including any patent extensions); or

(ii) a listed patent for which a certification has been submitted under subsections (b)(2)(A)(iii)

or (j)(2)(A)(vii)(III) of section 505,

the period during which an application may not be approved under section 505(c)(3) or section

505(j)(5)(B) shall be extended by a period of six months after the date the patent expires

(including any patent extensions); or

(B) if the drug is the subject of a listed patent for which a certification has been submitted

under subsection (b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) of section 505, and in the patent infringement

litigation resulting from the certification the court determines that the patent is valid and would

be infringed, the period during which an application may not be approved under section

505(c)(3) or section 505(j)(5)(B) shall be extended by a period of six months after the date the

patent expires (including any patent extensions).

(c) MARKET EXCLUSIVITY FOR ALREADY-MARKETED DRUGS.—If the Secretary

determines that information relating to the use of an approved drug in the pediatric population

may produce health benefits in that population and makes a written request to the holder of an

approved application under section 505(b)(1) for pediatric studies (which shall include a

timeframe for completing such studies) , the holder agrees to the request, the studies are

completed within any such timeframe, and the reports thereof are submitted in accordance

with subsection (d)(2) or accepted in accordance with subsection (d)(3)—

(1)(A)(i) the period referred to in subsection (c)(3)(D)(ii) of section 505, and in subsection

(j)(5)(F)(ii) of such section, is deemed to be five years and six months rather than five years,

and the references in subsections (c)(3)(D)(ii) and (j)(5)(F)(ii) of such section to four years, to

forty-eight months, and to seven and one-half years are deemed to be four and one-half years,

fifty-four months, and eight years, respectively; or

(ii) the period referred to in clauses (iii) and (iv) of subsection (c)(3)(D) of such section, and in

clauses (iii) and (iv) of subsection (j)(5)(F) of such section, is deemed to be three years and six

months rather than three years; and

(B) if the drug is designated under section 526 for a rare disease or condition, the period

referred to in section 527(a) is deemed to be seven years and six months rather than seven

years; and

(2)(A) if the drug is the subject of—

(i) a listed patent for which a certification has been submitted under subsection (b)(2)(A)(ii) or

(j)(2)(A)(vii)(II) of section 505 and for which pediatric studies were submitted prior to the

expiration of the patent (including any patent extensions); or

(ii) a listed patent for which a certification has been submitted under subsection (b)(2)(A)(iii) or

(j)(2)(A)(vii)(III) of section 505,

the period during which an application may not be approved under section 505(c)(3) or section

505(j)(5)(B)(ii) shall be extended by a period of six months after the date the patent expires

(including any patent extensions); or

(B) if the drug is the subject of a listed patent for which a certification has been submitted

under subsection (b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) of section 505, and in the patent infringement

litigation resulting from the certification the court determines that the patent is valid and would

be infringed, the period during which an application may not be approved under section

505(c)(3) or section 505(j)(5)(B) shall be extended by a period of six months after the date the

patent expires (including any patent extensions).

(d) CONDUCT OF PEDIATRIC STUDIES.—

(1) AGREEMENT FOR STUDIES.—The Secretary may, pursuant to a written request from the

Secretary under subsection (b) or (c), after consultation with—

(A) the sponsor of an application for an investigational new drug under section 505(i);

(B) the sponsor of an application for a new drug under section 505(b)(1); or

(C) the holder of an approved application for a drug under section 505(b)(1),

agree with the sponsor or holder for the conduct of pediatric studies for such drug. Such

agreement shall be in writing and shall include a timeframe for such studies.

(2) WRITTEN PROTOCOLS TO MEET THE STUDIES REQUIREMENT.— If the sponsor or

holder and the Secretary agree upon written protocols for the studies, the studies requirement

of subsection (b) or (c) is satisfied upon the completion of the studies and submission of the

reports thereof in accordance with the original written request and the written agreement

referred to in paragraph (1). In reaching an agreement regarding written protocols, the

Secretary shall take into account adequate representation of children of ethnic and racial

minorities. Not later than 60 days after the submission of the report of the studies, the

Secretary shall determine if such studies were or were not conducted in accordance with the

original written request and the written agreement and reported in accordance with the

requirements of the Secretary for filing and so notify the sponsor or holder.

(3) OTHER METHODS TO MEET THE STUDIES REQUIREMENT.— If the sponsor or holder

and the Secretary have not agreed in writing on the protocols for the studies, the studies

requirement of subsection (b) or (c) is satisfied when such studies have been completed and

the reports accepted by the Secretary. Not later than 90 days after the submission of the

reports of the studies, the Secretary shall accept or reject such reports and so notify the

sponsor or holder. The Secretary’s only responsibility in accepting or rejecting the reports shall

be to determine, within the 90 days, whether the studies fairly respond to the written request,

have been conducted in accordance with commonly accepted scientific principles and

protocols, and have been reported in accordance with the requirements of the Secretary for

filing.

(4) WRITTEN REQUEST TO HOLDERS OF APPROVED APPLICATIONS FOR DRUGS

THAT HAVE MARKET EXCLUSIVITY-

(A) REQUEST AND RESPONSE- If the Secretary makes a written request for pediatric

studies (including neonates, as appropriate) under subsection (c) to the holder of an

application approved under section 505(b)(1), the holder, not later than 180 days after

receiving the written request, shall respond to the Secretary as to the intention of the holder to

act on the request by--

(i) indicating when the pediatric studies will be initiated, if the holder agrees to the request; or

(ii) indicating that the holder does not agree to the request.

(B) NO AGREEMENT TO REQUEST-

(i) REFERRAL- If the holder does not agree to a written request within the time period

specified in subparagraph (A), and if the Secretary determines that there is a continuing need

for information relating to the use of the drug in the pediatric population (including neonates, as

appropriate), the Secretary shall refer the drug to the Foundation for the National Institutes of

Health established under section 499 of the Public Health Service Act (42 U.S.C. 290b)

(referred to in this paragraph as the `Foundation') for the conduct of the pediatric studies

described in the written request.

(ii) PUBLIC NOTICE- The Secretary shall give public notice of the name of the drug, the name

of the manufacturer, and the indications to be studied made in a referral under clause (i).

(C) LACK OF FUNDS- On referral of a drug under subparagraph (B)(i), the Foundation shall

issue a proposal to award a grant to conduct the requested studies unless the Foundation

certifies to the Secretary, within a timeframe that the Secretary determines is appropriate

through guidance, that the Foundation does not have funds available under section

499(j)(9)(B)(i) 26 to conduct the requested studies. If the Foundation so certifies, the Secretary

shall refer the drug for inclusion on the list established under section 409I of the Public Health

Service Act for the conduct of the studies.

(D) EFFECT OF SUBSECTION- Nothing in this subsection (including with respect to referrals

from the Secretary to the Foundation) alters or amends section 301(j) of this Act or section 552

of title 5 or section 1905 of title 18, United States Code.

(E) NO REQUIREMENT TO REFER- Nothing in this subsection shall be construed to require

that every declined written request shall be referred to the Foundation.

(F) WRITTEN REQUESTS UNDER SUBSECTION (b)- For drugs under subsection (b) for

which written requests have not been accepted, if the Secretary determines that there is a

continuing need for information relating to the use of the drug in the pediatric population

(including neonates, as appropriate), the Secretary shall issue a written request under

subsection (c) after the date of approval of the drug.

(e) DELAY OF EFFECTIVE DATE FOR CERTAIN APPLICATION.—If the Secretary

determines that the acceptance or approval of an application under section 505(b)(2) or 505(j)

for a new drug may occur after submission of reports of pediatric studies under this section,

which were submitted prior to the expiration of the patent (including any patent extension) or

the applicable period under clauses (ii) through (iv) of section 505(c)(3)(D) or clauses (ii)

through (iv) of section 505(j)(5)(F), but before the Secretary has determined whether the

requirements of subsection (d) have been satisfied, the Secretary shall delay the acceptance

or approval under section 505(b)(2) or 505(j) until the determination under subsection (d) is

made, but any such delay shall not exceed 90 days. In the event that requirements of this

section are satisfied, the applicable six month period under subsection ( b) or (c) shall be

deemed to have been running during the period of delay.

(f) NOTICE OF DETERMINATIONS ON STUDIES REQUIREMENT.— The Secretary shall

publish a notice of any determination that the requirements of subsection (d) have been met

and that submissions and approvals under subsection (b)(2) or (j) of section 505 for a drug will

be subject to the provisions of this section.

( g) LIMITATIONS.—A drug to which the six-month period under subsection (b) or (c) has

already been applied—

(1) may receive an additional six-month period under subsection (c)(1)(A)(ii) for a

supplemental application if all other requirements under this section are satisfied, except that

such a drug may not receive any additional such period under subsection (c)(2); and

(2) may not receive any additional such period under subsection (c)(1)(B).

( h) RELATIONSHIP TO PEDIATRIC RESEARCH REQUIREMENTS.—Notwithstanding any

other provision of law, if any pediatric study is required by a provision of law (including a

regulation) other than this section and such study meets the completeness, timeliness, and

other requirements of this section, such study shall be deemed to satisfy the requirement for

market exclusivity pursuant to this section.

(i) LABELING SUPPLEMENTS-

(1) PRIORITY STATUS FOR PEDIATRIC SUPPLEMENTS- Any supplement to an application

under section 505 proposing a labeling change pursuant to a report on a pediatric study under

this section--

(A) shall be considered to be a priority supplement; and

(B) shall be subject to the performance goals established by the Commissioner for priority

drugs.

(2) DISPUTE RESOLUTION-

(A) REQUEST FOR LABELING CHANGE AND FAILURE TO AGREE- If the Commissioner

determines that an application with respect to which a pediatric study is conducted under this

section is approvable and that the only open issue for final action on the application is the

reaching of an agreement between the sponsor of the application and the Commissioner on

appropriate changes to the labeling for the drug that is the subject of the application, not later

than 180 days after the date of submission of the application--

(i) the Commissioner shall request that the sponsor of the application make any labeling

change that the Commissioner determines to be appropriate; and

(ii) if the sponsor of the application does not agree to make a labeling change requested by the

Commissioner, the Commissioner shall refer the matter to the Pediatric Advisory Committee.

(B) ACTION BY THE PEDIATRIC ADVISORY SUBCOMMITTEE OF THE ANTI-INFECTIVE

DRUGS ADVISORY COMMITTEE- Not later than 90 days after receiving a referral under

subparagraph (A)(ii), the Pediatric Advisory Committee shall--

(i) review the pediatric study reports; and

(ii) make a recommendation to the Commissioner concerning appropriate labeling changes, if

any.

(C) CONSIDERATION OF RECOMMENDATIONS- The Commissioner shall consider the

recommendations of the Pediatric Advisory Committee and, if appropriate, not later than 30

days after receiving the recommendation, make a request to the sponsor of the application to

make any labeling change that the Commissioner determines to be appropriate.

(D) MISBRANDING- If the sponsor of the application, within 30 days after receiving a request

under subparagraph (C), does not agree to make a labeling change requested by the

Commissioner, the Commissioner may deem the drug that is the subject of the application to

be misbranded.

(E) NO EFFECT ON AUTHORITY- Nothing in this subsection limits the authority of the United

States to bring an enforcement action under this Act when a drug lacks appropriate pediatric

labeling. Neither course of action (the Pediatric Advisory Committee process or an

enforcement action referred to in the preceding sentence) shall preclude, delay, or serve as

the basis to stay the other course of action.

(j) DISSEMINATION OF PEDIATRIC INFORMATION-

(1) IN GENERAL- Not later than 180 days after the date of submission of a report on a

pediatric study under this section, the Commissioner shall make available to the public a

summary of the medical and clinical pharmacology reviews of pediatric studies conducted for

the supplement, including by publication in the Federal Register.

(2) EFFECT OF SUBSECTION- Nothing in this subsection alters or amends section 301(j) of

this Act or section 552 of title 5 or section 1905 of title 18, United States Code.'.

(k) CLARIFICATION OF INTERACTION OF MARKET EXCLUSIVITY UNDER THIS

SECTION AND MARKET EXCLUSIVITY AWARDED TO AN APPLICANT FOR APPROVAL

OF A DRUG UNDER SECTION 505(j)- If a 180-day period under section 505(j)(5)(B)(iv)

overlaps with a 6-month exclusivity period under this section, so that the applicant for approval

of a drug under section 505(j) entitled to the 180-day period under that section loses a portion

of the 180-day period to which the applicant is entitled for the drug, the 180-day period shall be

extended from--

(1) the date on which the 180-day period would have expired by the number of days of the

overlap, if the 180-day period would, but for the application of this subsection, expire after the

6-month exclusivity period; or

(2) the date on which the 6-month exclusivity period expires, by the number of days of the

overlap if the 180-day period would, but for the application of this subsection, expire during the

six-month exclusivity period.

(l) PROMPT APPROVAL OF DRUGS UNDER SECTION 505(j) WHEN PEDIATRIC

INFORMATION IS ADDED TO LABELING-

(1) GENERAL RULE- A drug for which an application has been submitted or approved under

section 505(j) shall not be considered ineligible for approval under that section or misbranded

under section 502 on the basis that the labeling of the drug omits a pediatric indication or any

other aspect of labeling pertaining to pediatric use when the omitted indication or other aspect

is protected by patent or by exclusivity under clause (iii) or (iv) of section 505(j)(5)(F).

(2) LABELING- Notwithstanding clauses (iii) and (iv) of section 505(j)(5)(F), the Secretary may

require that the labeling of a drug approved under section 505(j) that omits a pediatric

indication or other aspect of labeling as described in paragraph (1) include--

(A) a statement that, because of marketing exclusivity for a manufacturer--

(i) the drug is not labeled for pediatric use; or

(ii) in the case of a drug for which there is an additional pediatric use not referred to in

paragraph (1), the drug is not labeled for the pediatric use under paragraph (1); and

(B) a statement of any appropriate pediatric contraindications, warnings, or precautions that

the Secretary considers necessary.

(3) PRESERVATION OF PEDIATRIC EXCLUSIVITY AND OTHER PROVISIONS- This

subsection does not affect--

(A) the availability or scope of exclusivity under this section;

(B) the availability or scope of exclusivity under section 505 for pediatric formulations;

(C) the question of the eligibility for approval of any application under section 505(j) that omits

any other conditions of approval entitled to exclusivity under clause (iii) or (iv) of section

505(j)(5)(F); or

(D) except as expressly provided in paragraphs (1) and (2), the operation of section 505.

(m) REPORT.—The Secretary shall conduct a study and report to Congress not later than

January 1, 2001, based on the experience under the program established under this section.

The study and report shall examine all relevant issues, including—

(1) the effectiveness of the program in improving information about important pediatric uses for

approved drugs;

(2) the adequacy of the incentive provided under this section;

(3) the economic impact of the program on taxpayers and consumers, including the impact of

the lack of lower cost generic drugs on patients, including on lower income patients; and

(4) any suggestions for modification that the Secretary determines to be appropriate.

(n) SUNSET- A drug may not receive any 6-month period under subsection (b) or (c) 27

unless--

(1) on or before October 1, 2007 , the Secretary makes a written request for pediatric studies

of the drug;

(2) on or before October 1, 2007 , an application for the drug is accepted for filing under

section 505(b); and

(3) all requirements of this section are met.

SEC. 505B. 28 [21 U.S.C. 355c] RESEARCH INTO PEDIATRIC USES FOR DRUGS AND

BIOLOGICAL PRODUCTS.

(a) NEW DRUGS AND BIOLOGICAL PRODUCTS-

(1) IN GENERAL- A person that submits an application (or supplement to an application)—

(A) under section 505 for a new active ingredient, new indication, new dosage form, new

dosing regimen, or new route of administration; or

(B) under section 351 of the Public Health Service Act (42 U.S.C. 262) for a new active

ingredient, new indication, new dosage form, new dosing regimen, or new route of

administration; shall submit with the application the assessments described in paragraph (2).

(2) ASSESSMENTS-

(A) IN GENERAL- The assessments referred to in paragraph (1) shall contain data, gathered

using appropriate formulations for each age group for which the assessment is required, that

are adequate—

(i) to assess the safety and effectiveness of the drug or the biological product for the claimed

indications in all relevant pediatric subpopulations; and

(ii) to support dosing and administration for each pediatric subpopulation for which the drug or

the biological product is safe and effective.

(B) SIMILAR COURSE OF DISEASE OR SIMILAR EFFECT OF DRUG OR BIOLOGICAL

PRODUCT-

(i) IN GENERAL- If the course of the disease and the effects of the drug are sufficiently similar

in adults and pediatric patients, the Secretary may conclude that pediatric effectiveness can be

extrapolated from adequate and well-controlled studies in adults, usually supplemented with

other information obtained in pediatric patients, such as pharmacokinetic studies.

(ii) EXTRAPOLATION BETWEEN AGE GROUPS- A study may not be needed in each

pediatric age group if data from 1 age group can be extrapolated to another age group.

(3) DEFERRAL- On the initiative of the Secretary or at the request of the applicant, the

Secretary may defer submission of some or all assessments required under paragraph (1)

until a specified date after approval of the drug or issuance of the license for a biological

product if--

(A) the Secretary finds that--

(i) the drug or biological product is ready for approval for use in adults before pediatric studies

are complete;

(ii) pediatric studies should be delayed until additional safety or effectiveness data have been

collected; or

(iii) there is another appropriate reason for deferral; and

(B) the applicant submits to the Secretary—

(i) certification of the grounds for deferring the assessments;

(ii) a description of the planned or ongoing studies; and

(iii) evidence that the studies are being conducted or will be conducted with due diligence and

at the earliest possible time.

(4) WAIVERS-

(A) FULL WAIVER- On the initiative of the Secretary or at the request of an applicant, the

Secretary shall grant a full waiver, as appropriate, of the requirement to submit assessments

for a drug or biological product under this subsection if the applicant certifies and the Secretary

finds that--

(i) necessary studies are impossible or highly impracticable (because, for example, the

number of patients is so small or the patients are geographically dispersed);

(ii) there is evidence strongly suggesting that the drug or biological product would be

ineffective or unsafe in all pediatric age groups; or

(iii) the drug or biological product—

(I) does not represent a meaningful therapeutic benefit over existing therapies for pediatric

patients; and

(II) is not likely to be used in a substantial number of pediatric patients.

(B) PARTIAL WAIVER- On the initiative of the Secretary or at the request of an applicant, the

Secretary shall grant a partial waiver, as appropriate, of the requirement to submit

assessments for a drug or biological product under this subsection with respect to a specific

pediatric age group if the applicant certifies and the Secretary finds that—

(i) necessary studies are impossible or highly impracticable (because, for example, the

number of patients in that age group is so small or patients in that age group are

geographically dispersed);

(ii) there is evidence strongly suggesting that the drug or biological product would be

ineffective or unsafe in that age group;

(iii) the drug or biological product—

(I) does not represent a meaningful therapeutic benefit over existing therapies for pediatric

patients in that age group; and

(II) is not likely to be used by a substantial number of pediatric patients in that age group; or

(iv) the applicant can demonstrate that reasonable attempts to produce a pediatric formulation

necessary for that age group have failed

(C) PEDIATRIC FORMULATION NOT POSSIBLE- If a waiver is granted on the ground that it

is not possible to develop a pediatric formulation, the waiver shall cover only the pediatric

groups requiring that formulation.

(D) LABELING REQUIREMENT- If the Secretary grants a full or partial waiver because there

is evidence that a drug or biological product would be ineffective or unsafe in pediatric

populations, the information shall be included in the labeling for the drug or biological product.

(b) MARKETED DRUGS AND BIOLOGICAL PRODUCTS-

(1) IN GENERAL- After providing notice in the form of a letter and an opportunity for written

response and a meeting, which may include an advisory committee meeting, the Secretary

may (by order in the form of a letter) require the holder of an approved application for a drug

under section 505 or the holder of a license for a biological product under section 351 of the

Public Health Service Act (42 U.S.C. 262) to submit by a specified date the assessments

described in subsection (a)(2) if the Secretary finds that—

(A)(i) the drug or biological product is used for a substantial number of pediatric patients for the

labeled indications; and

(ii) the absence of adequate labeling could pose significant risks to pediatric patients; or

(B)(i) there is reason to believe that the drug or biological product would represent a

meaningful therapeutic benefit over existing therapies for pediatric patients for 1 or more of the

claimed indications; and

(ii) the absence of adequate labeling could pose significant risks to pediatric patients.

(2) WAIVERS-

(A) FULL WAIVER- At the request of an applicant, the Secretary shall grant a full waiver, as

appropriate, of the requirement to submit assessments under this subsection if the applicant

certifies and the Secretary finds that--

(i) necessary studies are impossible or highly impracticable (because, for example, the

number of patients in that age group is so small or patients in that age group are

geographically dispersed); or

(ii) there is evidence strongly suggesting that the drug or biological product would be

ineffective or unsafe in all pediatric age groups.

(B) PARTIAL WAIVER- At the request of an applicant, the Secretary shall grant a partial

waiver, as appropriate, of the requirement to submit assessments under this subsection with

respect to a specific pediatric age group if the applicant certifies and the Secretary finds that--

(i) necessary studies are impossible or highly impracticable (because, for example, the

number of patients in that age group is so small or patients in that age group are

geographically dispersed);

(ii) there is evidence strongly suggesting that the drug or biological product would be

ineffective or unsafe in that age group;

(iii)(I) the drug or biological product--

(aa) does not represent a meaningful therapeutic benefit over existing therapies for pediatric

patients in that age group; and

(bb) is not likely to be used in a substantial number of pediatric patients in that age group; and

(II) the absence of adequate labeling could not pose significant risks to pediatric patients; or

(iv) the applicant can demonstrate that reasonable attempts to produce a pediatric formulation

necessary for that age group have failed.

(C) PEDIATRIC FORMULATION NOT POSSIBLE- If a waiver is granted on the ground that it

is not possible to develop a pediatric formulation, the waiver shall cover only the pediatric

groups requiring that formulation.

(D) LABELING REQUIREMENT- If the Secretary grants a full or partial waiver because there

is evidence that a drug or biological product would be ineffective or unsafe in pediatric

populations, the information shall be included in the labeling for the drug or biological product.

(3) RELATIONSHIP TO OTHER PEDIATRIC PROVISIONS-

(A) NO ASSESSMENT WITHOUT WRITTEN REQUEST- No assessment may be required

under paragraph (1) for a drug subject to an approved application under section 505 unless--

(i) the Secretary has issued a written request for a related pediatric study under section 505A(c)

of this Act or section 409I of the Public Health Service Act (42 U.S.C. 284m);

(ii)(I) if the request was made under section 505A(c)--

(aa) the recipient of the written request does not agree to the request; or

(bb) the Secretary does not receive a response as specified under section 505A(d)(4)(A); or

(II) if the request was made under section 409I of the Public Health Service Act (42 U.S.C.

284m)--

(aa) the recipient of the written request does not agree to the request; or

(bb) the Secretary does not receive a response as specified under section 409I(c)(2) of that

Act; and

(iii)(I) the Secretary certifies under subparagraph (B) that there are insufficient funds under

sections 409I and 499 of the Public Health Service Act (42 U.S.C. 284m, 290b) to conduct the

study; or

(II) the Secretary publishes in the Federal Register a certification that certifies that--

(aa) no contract or grant has been awarded under section 409I or 499 of the Public Health

Service Act (42 U.S.C. 284m, 290b); and

(bb) not less than 270 days have passed since the date of a certification under subparagraph

(B) that there are sufficient funds to conduct the study.

(B) NO AGREEMENT TO REQUEST- Not later than 60 days after determining that no holder

will agree to the written request (including a determination that the Secretary has not received

a response specified under section 505A(d) of this Act or section 409I of the Public Health

Service Act (42 U.S.C. 284m), the Secretary shall certify whether the Secretary has sufficient

funds to conduct the study under section 409I or 499 of the Public Health Service Act (42

U.S.C. 284m, 290b), taking into account the prioritization under section 409I.

(c) MEANINGFUL THERAPEUTIC BENEFIT- For the purposes of paragraph (4)(A)(iii)(I) and

(4)(B)(iii)(I) of subsection (a) and paragraphs (1)(B)(i) and (2)(B)(iii)(I)(aa) of subsection (b), a

drug or biological product shall be considered to represent a meaningful therapeutic benefit

over existing therapies if the Secretary estimates that--

(1) if approved, the drug or biological product would represent a significant improvement in the

treatment, diagnosis, or prevention of a disease, compared with marketed products

adequately labeled for that use in the relevant pediatric population; or

(2) the drug or biological product is in a class of products or for an indication for which there is

a need for additional options.

(d) SUBMISSION OF ASSESSMENTS- If a person fails to submit an assessment described in

subsection (a)(2), or a request for approval of a pediatric formulation described in subsection

(a) or (b), in accordance with applicable provisions of subsections (a) and (b)--

(1) the drug or biological product that is the subject of the assessment or request may be

considered misbranded solely because of that failure and subject to relevant enforcement

action (except that the drug or biological product shall not be subject to action under section

303); but

(2) the failure to submit the assessment or request shall not be the basis for a proceeding--

(A) to withdraw approval for a drug under section 505(e); or

(B) to revoke the license for a biological product under section 351 of the Public Health Service

Act (42 U.S.C. 262).

(e) MEETINGS- Before and during the investigational process for a new drug or biological

product, the Secretary shall meet at appropriate times with the sponsor of the new drug or

biological product to discuss--

(1) information that the sponsor submits on plans and timelines for pediatric studies; or

(2) any planned request by the sponsor for waiver or deferral of pediatric studies.

(f) SCOPE OF AUTHORITY- Nothing in this section provides to the Secretary any authority to

require a pediatric assessment of any drug or biological product, or any assessment regarding

other populations or uses of a drug or biological product, other than the pediatric assessments

described in this section.

(g) ORPHAN DRUGS- Unless the Secretary requires otherwise by regulation, this section

does not apply to any drug for an indication for which orphan designation has been granted

under section 526.

(h) INTEGRATION WITH OTHER PEDIATRIC STUDIES- The authority under this section

shall remain in effect so long as an application subject to this section may be accepted for filing

by the Secretary on or before the date specified in section 505A(n).

SEC. 506. [21 U.S.C. 356] FAST TRACK PRODUCTS.

(a) DESIGNATION OF DRUG AS A FAST TRACK PRODUCT.—

(1) IN GENERAL.—The Secretary shall, at the request of the sponsor of a new drug, facilitate

the development and expedite the review of such drug if it is intended for the treatment of a

serious or life-threatening condition and it demonstrates the potential to address unmet

medical needs for such a condition. (In this section, such a drug is referred to as a ‘‘fast track

product’’.)

(2) REQUEST FOR DESIGNATION.—The sponsor of a new drug may request the Secretary

to designate the drug as a fast track product. A request for the designation may be made

concurrently with, or at any time after, submission of an application for the investigation of the

drug under section 505(i) or section 351(a)(3) of the Public Health Service Act.

(3) DESIGNATION.—Within 60 calendar days after the receipt of a request under paragraph

(2), the Secretary shall determine whether the drug that is the subject of the request meets the

criteria described in paragraph (1). If the Secretary finds that the drug meets the criteria, the

Secretary shall designate the drug as a fast track product and shall take such actions as are

appropriate to expedite the development and review of the application for approval of such

product.

(b) APPROVAL OF APPLICATION FOR A FAST TRACK PRODUCT.—

(1) IN GENERAL.—The Secretary may approve an application for approval of a fast track

product under section 505(c) or section 351 of the Public Health Service Act upon a

determination that the product has an effect on a clinical endpoint or on a surrogate endpoint

that is reasonably likely to predict clinical benefit.

(2) LIMITATION.—Approval of a fast track product under this subsection may be subject to the

requirements—

(A) that the sponsor conduct appropriate post-approval studies to validate the surrogate

endpoint or otherwise confirm the effect on the clinical endpoint; and

(B) that the sponsor submit copies of all promotional materials related to the fast track product

during the preapproval review period and, following approval and for such period thereafter as

the Secretary determines to be appropriate, at least 30 days prior to dissemination of the

materials.

(3) EXPEDITED WITHDRAWAL OF APPROVAL.—The Secretary may withdraw approval of a

fast track product using expedited procedures (as prescribed by the Secretary in regulations

which shall include an opportunity for an informal hearing) if—

(A) the sponsor fails to conduct any required post-approval study of the fast track drug with

due diligence;

(B) a post-approval study of the fast track product fails to verify clinical benefit of the product;

(C) other evidence demonstrates that the fast track product is not safe or effective under the

conditions of use; or

(D) the sponsor disseminates false or misleading promotional materials with respect to the

product.

(c) REVIEW OF INCOMPLETE APPLICATIONS FOR APPROVAL OF A FAST TRACK

PRODUCT.—

(1) IN GENERAL.—If the Secretary determines, after preliminary evaluation of clinical data

submitted by the sponsor, that a fast track product may be effective, the Secretary shall

evaluate for filing, and may commence review of portions of, an application for the approval of

the product before the sponsor submits a complete application. The Secretary shall

commence such review only if the applicant—

(A) provides a schedule for submission of information necessary to make the application

complete; and

(B) pays any fee that may be required under section 736.

(2) EXCEPTION.—Any time period for review of human drug applications that has been

agreed to by the Secretary and that has been set forth in goals identified in letters of the

Secretary (relating to the use of fees collected under section 736 to expedite the drug

development process and the review of human drug applications) shall not apply to an

application submitted under paragraph (1) until the date on which the application is complete.

(d) AWARENESS EFFORTS.—The Secretary shall—

(1) develop and disseminate to physicians, patient organizations, pharmaceutical and

biotechnology companies, and other appropriate persons a description of the provisions of this

section applicable to fast track products; and

(2) establish a program to encourage the development of surrogate endpoints that are

reasonably likely to predict clinical benefit for serious or life-threatening conditions for which

there exist significant unmet medical needs.

SEC. 506A. [ 21 U.S.C. 356a] MANUFACTURING CHANGES.

(a) IN GENERAL.—With respect to a drug for which there is in effect an approved application

under section 505 or 512 or a license under section 351 of the Public Health Service Act, a

change from the manufacturing process approved pursuant to such application or license may

be made, and the drug as made with the change may be distributed, if—

(1) the holder of the approved application or license (referred to in this section as a ‘‘holder’’)

has validated the effects of the change in accordance with subsection (b); and

(2)(A) in the case of a major manufacturing change, the holder has complied with the

requirements of subsection (c); or

(B) in the case of a change that is not a major manufacturing change, the holder complies with

the applicable requirements of subsection (d).

(b) VALIDATION OF EFFECTS OF CHANGES.—For purposes of subsection (a)(1), a drug

made with a manufacturing change (whether a major manufacturing change or otherwise) may

be distributed only if, before distribution of the drug as so made, the holder involved validates

the effects of the change on the identity, strength, quality, purity, and potency of the drug as

the identity, strength, quality, purity, and potency may relate to the safety or effectiveness of

the drug.

(c) MAJOR MANUFACTURING CHANGES.—

(1) REQUIREMENT OF SUPPLEMENTAL APPLICATION.—For purposes of subsection

(a)(2)(A), a drug made with a major manufacturing change may be distributed only if, before

the distribution of the drug as so made, the holder involved submits to the Secretary a

supplemental application for such change and the Secretary approves the application. The

application shall contain such information as the Secretary determines to be appropriate, and

shall include the information developed under subsection (b) by the holder in validating the

effects of the change.

(2) CHANGES QUALIFYING AS MAJOR CHANGES.—For purposes of subsection (a)(2)(A),

a major manufacturing change is a manufacturing change that is determined by the Secretary

to have substantial potential to adversely affect the identity, strength, quality, purity, or potency

of the drug as they may relate to the safety or effectiveness of a drug. Such a change includes

a change that—

(A) is made in the qualitative or quantitative formulation of the drug involved or in the

specifications in the approved application or license referred to in subsection (a) for the drug

(unless exempted by the Secretary by regulation or guidance from the requirements of this

subsection);

(B) is determined by the Secretary by regulation or guidance to require completion of an

appropriate clinical study demonstrating equivalence of the drug to the drug as manufactured

without the change; or

(C) is another type of change determined by the Secretary by regulation or guidance to have a

substantial potential to adversely affect the safety or effectiveness of the drug.

(d) OTHER MANUFACTURING CHANGES.—

(1) IN GENERAL.—For purposes of subsection (a)(2)(B), the Secretary may regulate drugs

made with manufacturing changes that are not major manufacturing changes as follows:

(A) The Secretary may in accordance with paragraph (2) authorize holders to distribute such

drugs without submitting a supplemental application for such changes.

(B) The Secretary may in accordance with paragraph (3) require that, prior to the distribution of

such drugs, holders submit to the Secretary supplemental applications for such changes.

(C) The Secretary may establish categories of such changes and designate categories to

which subparagraph (A) applies and categories to which subparagraph (B) applies.

(2) CHANGES NOT REQUIRING SUPPLEMENTAL APPLICATION.—

(A) SUBMISSION OF REPORT.—A holder making a manufacturing change to which

paragraph (1)(A) applies shall submit to the Secretary a report on the change, which shall

contain such information as the Secretary determines to be appropriate, and which shall

include the information developed under subsection (b) by the holder in validating the effects

of the change. The report shall be submitted by such date as the Secretary may specify.

(B) AUTHORITY REGARDING ANNUAL REPORTS.—In the case of a holder that during a

single year makes more than one manufacturing change to which paragraph (1)(A) applies,

the Secretary may in carrying out subparagraph (A) authorize the holder to comply with such

subparagraph by submitting a single report for the year that provides the information required

in such subparagraph for all the changes made by the holder during the year.

(3) CHANGES REQUIRING SUPPLEMENTAL APPLICATION.—

(A) SUBMISSION OF SUPPLEMENTAL APPLICATION.—The supplemental application

required under paragraph (1)(B) for a manufacturing change shall contain such information as

the Secretary determines to be appropriate, which shall include the information developed

under subsection (b) by the holder in validating the effects of the change.

(B) AUTHORITY FOR DISTRIBUTION.—In the case of a manufacturing change to which

paragraph (1)(B) applies:

(i) The holder involved may commence distribution of the drug involved 30 days after the

Secretary receives the supplemental application under such paragraph, unless the Secretary

notifies the holder within such 30-day period that prior approval of the application is required

before distribution may be commenced.

(ii) The Secretary may designate a category of such changes for the purpose of providing that,

in the case of a change that is in such category, the holder involved may commence

distribution of the drug involved upon the receipt by the Secretary of a supplemental

application for the change.

(iii) If the Secretary disapproves the supplemental application, the Secretary may order the

manufacturer to cease the distribution of the drugs that have been made with the

manufacturing change.

SEC. 506B. [ 21 U.S.C. 356b] REPORTS OF POSTMARKETING STUDIES.

(a) SUBMISSION.—

(1) IN GENERAL.—A sponsor of a drug that has entered into an agreement with the Secretary

to conduct a postmarketing study of a drug shall submit to the Secretary, within 1 year after the

approval of such drug and annually thereafter until the study is completed or terminated, a

report of the progress of the study or the reasons for the failure of the sponsor to conduct the

study. The report shall be submitted in such form as is prescribed by the Secretary in

regulations issued by the Secretary.

(2) AGREEMENTS PRIOR TO EFFECTIVE DATE.—Any agreement entered into between the

Secretary and a sponsor of a drug, prior to the date of enactment of the Food and Drug

Administration Modernization Act of 1997, to conduct a postmarketing study of a drug shall be

subject to the requirements of paragraph (1). An initial report for such an agreement shall be

submitted within 6 months after the date of the issuance of the regulations under paragraph

(1).

(b) CONSIDERATION OF INFORMATION AS PUBLIC INFORMATION.— Any information

pertaining to a report described in subsection (a) shall be considered to be public information

to the extent that the information is necessary—

(1) to identify the sponsor; and

(2) to establish the status of a study described in subsection (a) and the reasons, if any, for any

failure to carry out the study.

(c) STATUS OF STUDIES AND REPORTS.—The Secretary shall annually develop and

publish in the Federal Register a report that provides information on the status of the

postmarketing studies—

(1) that sponsors have entered into agreements to conduct; and

(2) for which reports have been submitted under subsection (a)(1).

(d) DISCLOSURE.—If a sponsor fails to complete an agreed upon study required by this

section by its original or otherwise negotiated deadline, the Secretary shall publish a statement

on the Internet site of the Food and Drug Administration stating that the study was not

completed and, if the reasons for such failure to complete the study were not satisfactory to the

Secretary, a statement that such reasons were not satisfactory to the Secretary.

(e) NOTIFICATION.—With respect to studies of the type required under section 506(b)(2)(A)

or under section 314.510 or 601.41 of title 21, Code of Federal Regulations, as each of such

sections was in effect on the day before the effective date 29 of this subsection, the Secretary

may require that a sponsor who, for reasons not satisfactory to the Secretary, fails to complete

by its deadline a study under any of such sections of such type for a drug or biological product

(including such a study conducted after such effective date) notify practitioners who prescribe

such drug or biological product of the failure to complete such study and the questions of

clinical benefit, and, where appropriate, questions of safety, that remain unanswered as a

result of the failure to complete such study. Nothing in this subsection shall be construed as

altering the requirements of the types of studies required under section 506(b)(2)(A) or under

section 314.510 or 601.41 of title 21, Code of Federal Regulations, as so in effect, or as

prohibiting the Secretary from modifying such sections of title 21 of such Code to provide for

studies in addition to those of such type..

SEC. 506C. [ 21 U.S.C. 356c] DISCONTINUANCE OF A LIFE SAVING PRODUCT.

(a) IN GENERAL.—A manufacturer that is the sole manufacturer of a drug—

(1) that is—

(A) life-supporting;

(B) life-sustaining; or

(C) intended for use in the prevention of a debilitating disease or condition;

(2) for which an application has been approved under section 505(b) or 505(j); and

(3) that is not a product that was originally derived from human tissue and was replaced by a

recombinant product, shall notify the Secretary of a discontinuance of the manufacture of the

drug at least 6 months prior to the date of the discontinuance.

(b) REDUCTION IN NOTIFICATION PERIOD.—The notification period required under

subsection (a) for a manufacturer may be reduced if the manufacturer certifies to the Secretary

that good cause exists for the reduction, such as a situation in which—

(1) a public health problem may result from continuation of the manufacturing for the 6-month

period;

(2) a biomaterials shortage prevents the continuation of the manufacturing for the 6-month

period;

(3) a liability problem may exist for the manufacturer if the manufacturing is continued for the

6-month period;

(4) continuation of the manufacturing for the 6-month period may cause substantial economic

hardship for the manufacturer;

(5) the manufacturer has filed for bankruptcy under chapter 7 or 11 of title 11, United States

Code; or

(6) the manufacturer can continue the distribution of the drug involved for 6 months.

(c) DISTRIBUTION.—To the maximum extent practicable, the Secretary shall distribute

information on the discontinuation of the drugs described in subsection (a) to appropriate

physician and patient organizations.

[Section 507 repealed by Pub. L. 105–115, November 21, 1997.]

AUTHORITY TO DESIGNATE OFFICIAL NAMES

SEC. 508. 30 [21 U.S.C. 358] (a) The Secretary may designate an official name for any drug or

device if he determines that such action is necessary or desirable in the interest of usefulness

and simplicity. Any official name designated under this section for any drug or device shall be

the only official name of that drug or device used in any official compendium published after

such name has been prescribed or for any other purpose of this Act. In no event, however,

shall the Secretary establish an official name so as to infringe a valid trademark.

(b) Within a reasonable time after the effective date of this section, and at such other times as

he may deem necessary, the Secretary shall cause a review to be made of the official names

by which drugs are identified in the official United States Pharmacopeia, the official

Homeopathic Pharmacopeia of the United States, and the official National Formulary, and all

supplements thereto, and at such times as he may deem necessary shall cause a review to be

made of the official names by which devices are identified in any official compendium (and all

supplements thereto) to determine whether revision of any of those names is necessary or

desirable in the interest of usefulness and simplicity.

(c) Whenever he determines after any such review that (1) any such official name is unduly

complex or is not useful for any other reason, (2) two or more official names have been applied

to a single drug or device, or to two or more drugs which are identical in chemical structure and

pharmacological action and which are substantially identical in strength, quality, and purity, or

to two or more devices which are substantially equivalent in design and purpose or (3) no

official name has been applied to a medically useful drug or device, he shall transmit in writing

to the compiler of each official compendium in which that drug or drugs or device are identified

and recognized his request for the recommendation of a single official name for such drug or

drugs or device which will have usefulness and simplicity. Whenever such a single official

name has not been recommended within one hundred and eighty days after such request, or

the Secretary determines that any name so recommended is not useful for any reason, he

shall designate a single official name for such drug or drugs or device. Whenever he

determines that the name so recommended is useful, he shall designate that name as the

official name of such drug or drugs or device. Such designation shall be made as a regulation

upon public notice and in accordance with the procedure set forth in section 553 of title 5,

United States Code.

(d) After each such review, and at such other times as the Secretary may determine to be

necessary or desirable, the Secretary shall cause to be compiled, published, and publicly

distributed a list which shall list all revised official names of drugs or devices designated under

this section and shall contain such descriptive and explanatory matter as the Secretary may

determine to be required for the effective use of those names.

(e) Upon a request in writing by any compiler of any official compendium that the Secretary

exercise the authority granted to him under section 508(a), he shall upon public notice and in

accordance with the procedure set forth in section 553 of title 5, United States Code designate

the official name of the drug or device for which the request is made.

NONAPPLICABILITY TO COSMETICS

SEC. 509. [21 U.S.C. 359]This chapter, as amended by the Drug Amendments of 1962, shall

not apply to any cosmetic unless such cosmetic is also a drug or device or component thereof.

REGISTRATION OF PRODUCERS OF DRUGS AND DEVICES 31

SEC. 510. [21 U.S.C. 360] (a) As used in this section—

(1) the term ‘‘manufacture, preparation, propagation, compounding, or processing’’ shall

include repackaging or otherwise changing the container, wrapper, or labeling of any drug

package or device package in furtherance of the distribution of the drug or device from the

original place of manufacture to the person who makes final delivery or sale to the ultimate

consumer or user; and

(2) the term ‘‘name’’ shall include in the case of a partnership the name of each partner and, in

the case of a corporation, the name of each corporate officer and director, and the State of

incorporation.

(b) On or before December 31 of each year every person who owns or operates any

establishment in any State engaged in the manufacture, preparation, propagation,

compounding, or processing of a drug or drugs or a device or devices shall register with the

Secretary his name, places of business, and all such establishments.

(c) Every person upon first engaging in the manufacture, preparation, propagation,

compounding, or processing of a drug or drugs or a device or devices in any establishment

which he owns or operates in any State shall immediately register with the Secretary his name,

place of business, and such establishment.

(d) Every person duly registered in accordance with the foregoing subsections of this section

shall immediately register with the Secretary any additional establishment which he owns or

operates in any State and in which he begins the manufacture, preparation, propagation,

compounding, or processing of a drug or drugs or a device or devices.

(e) The Secretary may assign a registration number to any person or any establishment

registered in accordance with this section. The Secretary may also assign a listing number to

each drug or class of drugs listed under subsection (j). Any number assigned pursuant to the

preceding sentence shall be the same as that assigned pursuant to the National Drug Code.

The Secretary may by regulation prescribe a uniform system for the identification of devices

intended for human use and may require that persons who are required to list such devices

pursuant to subsection (j) shall list such devices in accordance with such system.

(f) The Secretary shall make available for inspection, to any person so requesting, any

registration filed pursuant to this section; except that any list submitted pursuant to paragraph

(3) of subsection (j) and the information accompanying any list or notice filed under paragraph

(1) or (2) of that subsection shall be exempt from such inspection unless the Secretary finds

that such an exemption would be inconsistent with protection of the public health.

(g) The foregoing subsections of this section shall not apply to—

(1) pharmacies which maintain establishments in conformance with any applicable local laws

regulating the practice of pharmacy and medicine and which are regularly engaged in

dispensing prescription drugs or devices, upon prescriptions of practitioners licensed to

administer such drugs or devices to patients under the care of such practitioners in the course

of their professional practice, and which do not manufacture, prepare, propagate, compound,

or process drugs or devices for sale other than in the regular course of their business of

dispensing or selling drugs or devices at retail;

(2) practitioners licensed by law to prescribe or administer drugs or devices and who

manufacture, prepare, propagate, compound, or process drugs or devices solely for use in the

course of their professional practice;

(3) persons who manufacture, prepare, propagate, compound, or process drugs or devices

solely for use in research, teaching, or chemical analysis and not for sale;

(4) any distributor who acts as a wholesale distributor of devices, and who does not

manufacture, repackage, process, or relabel a device; or

(5) such other classes of persons as the Secretary may by regulation exempt from the

application of this section upon a finding that registration by such classes of persons in

accordance with this section is not necessary for the protection of the public health.

In this subsection, the term ‘‘wholesale distributor’’ means any person (other than the

manufacturer or the initial importer) who distributes a device from the original place of

manufacture to the person who makes the final delivery or sale of the device to the ultimate

consumer or user.

(h) Every establishment in any State registered with the Secretary pursuant to this section

shall be subject to inspection pursuant to section 704 and every such establishment engaged

in the manufacture, propagation, compounding, or processing of a drug or drugs or of a device

or devices classified in class II or III shall be so inspected by one or more officers or

employees duly designated by the Secretary , or by persons accredited to conduct inspections

under section 704(g), at least once in the 2-year period beginning with the date of registration

of such establishment pursuant to this section and at least once in every successive 2-year

period thereafter.

(i)(1) On or before December 31 of each year, any establishment within any foreign country

engaged in the manufacture, preparation, propagation, compounding, or processing of a drug

or a device that is imported or offered for import into the United States shall, through electronic

means in accordance with the criteria of the Secretary, register with the Secretary the name

and place of business of the establishment, the name of the United States agent for the

establishment, the name of each importer of such drug or device in the United States that is

known to the establishment, and the name of each person who imports or offers for import

such drug or device to the United States for purposes of importation.

(2) The establishment shall also provide the information required by subsection (j).

(3) The Secretary is authorized to enter into cooperative arrangements with officials of foreign

countries to ensure that adequate and effective means are available for purposes of

determining, from time to time, whether drugs or devices manufactured, prepared, propagated,

compounded, or processed by an establishment described in paragraph (1), if imported or

offered for import into the United States, shall be refused admission on any of the grounds set

forth in section 801(a).

(j)(1) Every person who registers with the Secretary under subsection (b), (c), (d) or (i) shall, at

the time of registration under any such subsection, file with the Secretary a list of all drugs and

a list of all devices and a brief statement of the basis for believing that each device included in

the list is a device rather than a drug (with each drug and device in each list listed by its

established name (as defined in section 502(e)) and by any proprietary name) which are being

manufactured, prepared, propagated, compounded, or processed by him for commercial

distribution and which he has not included in any list of drugs or devices filed by him with the

Secretary under this paragraph or paragraph (2) before such time of registration. Such list

shall be prepared in such form and manner as the Secretary may prescribe and shall be

accompanied by—

(A) in the case of a drug contained in the applicable list and subject to section 505 or 512, or a

device intended for human use contained in the applicable list with respect to which a

performance standard has been established under section 514 or which is subject to section

515, a reference to the authority for the marketing of such drug or device and a copy of all

labeling for such drug or device;

(B) in the case of any other drug or device contained in an applicable list—

(i) which drug is subject to section 503(b)(1), or which device is a restricted device, a copy of

all labeling for such drug or device, a representative sampling of advertisements for such drug

or device, and, upon request made by the Secretary for good cause, a copy of all

advertisements for a particular drug product or device, or

(ii) which drug is not subject to section 503(b)(1) or which device is not a restricted device, the

label and package insert for such drug or device and a representative sampling of any other

labeling for such drug or device;

(C) in the case of any drug contained in an applicable list which is described in subparagraph

(B), a quantitative listing of its active ingredient or ingredients, except that with respect to a

particular drug product the Secretary may require the submission of a quantitative listing of all

ingredients if he finds that such submission is necessary to carry out the purposes of this Act;

and

(D) if the registrant filing a list has determined that a particular drug product or device

contained in such list is not subject to section 505 or 512, or the particular device contained in

such list is not subject to a performance standard established under section 514 or to section

515 or is not a restricted device, a brief statement of the basis upon which the registrant made

such determination if the Secretary requests such a statement with respect to that particular

drug product or device.

(2) Each person who registers with the Secretary under this section shall report to the

Secretary once during the month of June of each year and once during the month of

December of each year the following information:

(A) A list of each drug or device introduced by the registrant for commercial distribution which

has not been included in any list previously filed by him with the Secretary under this

subparagraph or paragraph (1) of this subsection. A list under this subparagraph shall list a

drug or device by its established name (as defined in section 502(e)) and by any proprietary

name it may have and shall be accompanied by the other information required by paragraph

(1).

(B) If since the date the registrant last made a report under this paragraph (or if he has not

made a report under this paragraph, since the effective date of this subsection 32 ) he has

discontinued the manufacture, preparation, propagation, compounding, or processing for

commercial distribution of a drug or device included in a list filed by him under subparagraph

(A) or paragraph (1); notice of such discontinuance, the date of such discontinuance, and the

identity (by established name (as defined in section 502(e)) and by any proprietary name) of

such drug or device.

(C) If since the date the registrant reported pursuant to subparagraph (B) a notice of

discontinuance he has resumed the manufacture, preparation, propagation, compounding, or

processing for commercial distribution of the drug or device with respect to which such notice

of discontinuance was reported; notice of such resumption, the date of such resumption, the

identity of such drug or device (by established name (as defined in section 502(e)) and by any

proprietary name), and the other information required by paragraph (1), unless the registrant

has previously reported such resumption to the Secretary pursuant to this subparagraph.

(D) Any material change in any information previously submitted pursuant to this paragraph or

paragraph (1).

(3) The Secretary may also require each registrant under this section to submit a list of each

drug product which (A) the registrant is manufacturing, preparing, propagating, compounding,

or processing for commercial distribution, and (B) contains a particular ingredient. The

Secretary may not require the submission of such a list unless he has made a finding that the

submission of such a list is necessary to carry out the purposes of this Act.

(k) Each person who is required to register under this section and who proposes to begin the

introduction or delivery for introduction into interstate commerce for commercial distribution of

a device intended for human use shall, at least ninety days before making such introduction or

delivery, report to the Secretary or person who is accredited under section 523(a) (in such

form and manner as the Secretary shall by regulation prescribe)—

(1) the class in which the device is classified under section 513 or if such person determines

that the device is not classified under such section, a statement of that determination and the

basis for such person’s determination that the device is or is not so classified, and

(2) action taken by such person to comply with requirements under section 514 or 515 which

are applicable to the device.

(l) A report under subsection (k) is not required for a device intended for human use that is

exempted from the requirements of this subsection under subsection (m) or is within a type

that has been classified into class I under section 513. The exception established in the

preceding sentence does not apply to any class I device that is intended for a use which is of

substantial importance in preventing impairment of human health, or to any class I device that

presents a potential unreasonable risk of illness or injury.

(m)(1) Not later than 60 days after the date of enactment of the Food and Drug Administration

Modernization Act of 1997, the Secretary shall publish in the Federal Register a list of each

type of class II device that does not require a report under subsection (k) to provide reasonable

assurance of safety and effectiveness. Each type of class II device identified by the Secretary

as not requiring the report shall be exempt from the requirement to provide a report under

subsection (k) as of the date of the publication of the list in the Federal Register. The Secretary

shall publish such list on the Internet site of the Food and Drug Administration. The list so

published shall be updated not later than 30 days after each revision of the list by the

Secretary.

(2) Beginning on the date that is 1 day after the date of the publication of a list under this

subsection, the Secretary may exempt a class II device from the requirement to submit a

report under subsection (k), upon the Secretary’s own initiative or a petition of an interested

person, if the Secretary determines that such report is not necessary to assure the safety and

effectiveness of the device. The Secretary shall publish in the Federal Register notice of the

intent of the Secretary to exempt the device, or of the petition, and provide a 30-day period for

public comment. Within 120 days after the issuance of the notice in the Federal Register, the

Secretary shall publish an order in the Federal Register that sets forth the final determination

of the Secretary regarding the exemption of the device that was the subject of the notice. If the

Secretary fails to respond to a petition within 180 days of receiving it, the petition shall be

deemed to be granted.

(n) The Secretary shall review the report required in subsection (k) and make a determination

under section 513(f)(1) not later than 90 days after receiving the report.

(o)(1) With respect to reprocessed single-use devices for which reports are required under

subsection (k):

(A) The Secretary shall identify such devices or types of devices for which reports under such

subsection must, in order to ensure that the device is substantially equivalent to a predicate

device, include validation data, the types of which shall be specified by the Secretary,

regarding cleaning and sterilization, and functional performance demonstrating that the

single-use device will remain substantially equivalent to its predicate device after the maximum

number of times the device is reprocessed as intended by the person submitting the premarket

notification. Within six months after enactment of this subsection, the Secretary shall publish in

the Federal Register a list of the types so identified, and shall revise the list as appropriate.

Reports under subsection (k) for devices or types of devices within a type included on the list

are, upon publication of the list, required to include such validation data.

(B) In the case of each report under subsection (k) that was submitted to the Secretary before

the publication of the initial list under subparagraph (A), or any revision thereof, and was for a

device or type of device included on such list, the person who submitted the report under

subsection (k) shall submit validation data as described in subparagraph (A) to the Secretary

not later than nine months after the publication of the list. During such nine-month period, the

Secretary may not take any action under this Act against such device solely on the basis that

the validation data for the device have not been submitted to the Secretary. After the

submission of the validation data to the Secretary, the Secretary may not determine that the

device is misbranded under section 502(o), or adulterated under section 501(f)(1)(B), or take

action against the device under section 301(p) for failure to provide any information required

by subsection (k) until (i) the review is terminated by withdrawal of the submission of the report

under subsection (k); (ii) the Secretary finds the data to be acceptable and issues a letter; or (iii)

the Secretary determines that the device is not substantially equivalent to a predicate device.

Upon a determination that a device is not substantially equivalent to a predicate device, or if

such submission is withdrawn, the device can no longer be legally marketed.

(C) In the case of a report under subsection (k) for a device identified under subparagraph (A)

that is of a type for which the Secretary has not previously received a report under such

subsection, the Secretary may, in advance of revising the list under subparagraph (A) to

include such type, require that the report include the validation data specified in subparagraph

(A).

(D) Section 502(o) applies with respect to the failure of a report under subsection (k) to include

validation data required under subparagraph (A).

(2) With respect to critical or semi-critical reprocessed single-use devices that, under

subsection (l) or (m), are exempt from the requirement of submitting reports under subsection

(k):

(A) The Secretary shall identify such devices or types of devices for which such exemptions

should be terminated in order to provide a reasonable assurance of the safety and

effectiveness of the devices. <> The Secretary shall publish in the Federal Register a list of the

devices or types of devices so identified, and shall revise the list as appropriate. The

exemption for each device or type included on the list is terminated upon the publication of the

list. For each report under subsection (k) submitted pursuant to this subparagraph the

Secretary shall require the validation data described in paragraph (1)(A).

(B) For each device or type of device included on the list under subparagraph (A), a report

under subsection (k) shall be submitted to the Secretary not later than 15 months after the

publication of the initial list, or a revision of the list, whichever terminates the exemption for the

device. During such 15-month period, the Secretary may not take any action under this Act

against such device solely on the basis that such report has not been submitted to the

Secretary. After the submission of the report to the Secretary the Secretary may not determine

that the device is misbranded under section 502(o), or adulterated under section 501(f)(1)(B),

or take action against the device under section 301(p) for failure to provide any information

required by subsection (k) until (i) the review is terminated by withdrawal of the submission; (ii)

the Secretary determines by order that the device is substantially equivalent to a predicate

device; or (iii) the Secretary determines by order that the device is not substantially equivalent

to a predicate device. Upon a determination that a device is not substantially equivalent to a

predicate device, the device can no longer be legally marketed.

(C) In the case of semi-critical devices, the initial list under subparagraph (A) shall be

published not later than 18 months after the effective date of this subsection. In the case of

critical devices, the initial list under such subparagraph shall be published not later than six

months after such effective date.

(D) Section 502(o) applies with respect to the failure to submit a report under subsection (k)

that is required pursuant to subparagraph (A), including a failure of the report to include

validation data required in such subparagraph.

(E) The termination under subparagraph (A) of an exemption under subsection (l) or (m) for a

critical or semi-critical reprocessed single-use device does not terminate the exemption under

subsection (l) or (m) for the original device.

(p) Registrations under subsections (b), (c), (d), and (i) (including the submission of updated

information) shall be submitted to the Secretary by electronic means, upon a finding by the

Secretary that the electronic receipt of such registrations is feasible, unless the Secretary

grants a request for waiver of such requirement because use of electronic means is not

reasonable for the person requesting such waiver.

SEC. 511. Repealed by section 701(a) of Public Law 91-513.

Footnotes: Chapter V, Sections 501-510

1. See footnote for section 403(h)(3) regarding the stylistic use of a list consisting of "(a)",

"(b)", etc.

2. So in law. Probably should be "subparagraph".

3. See footnote for section 403(h)(3) regarding the stylistic use of a list consisting of "(a)",

"(b)", etc.

4. Paragraph (d) was struck by section 126(6) of Public Law 105-115 (111 Stat.2327).

5. Paragraph (k) was struck by section 125(a)(2)(B) of Public Law 105–115 (111 Stat. 2325).

Paragraph (l) was struck by section 125(b)(2)(D) of such Public Law.

6. 2 So in law. Probably should be "paragraph (e)".

7. So in law. Probably should be "This paragraph".

8. Sentence was added by title I of Public Law 95–633. Section 112 of such Public Law

provided as follows: "This title shall take effect on the date the Convention on Psychotropic

Substances, signed at Vienna, Austria on February 21, 1971, enters into force in respect to the

United States.". The Convention entered into force in respect to the United States on July 15,

1980.

9. Paragraph (u) was added by section 301(a) of Public Law 107–250 (116 Stat. 1616), which

was enacted October 26, 2002. Subsection (b) of such section (as amended by section 2(c)(1)

of Public Law 108–214; 118 Stat. 575) provides as follows:

(b) EFFECTIVE DATE.—The amendment made by subsection (a) takes effect 36 months after

the date of the enactment of this Act, and only applies to devices introduced or delivered for

introduction into interstate commerce after such effective date.

10. Paragraph (v) was added by section 302(a)(1) of Public Law 107–250 (116 Stat. 1616),

which was enacted October 26, 2002. Paragraph (2) of such subsection provides as follows:

(2) EFFECTIVE DATE.—The amendment made by paragraph (1) takes effect 15 months after

the date of the enactment of this Act, and only applies to devices introduced or delivered for

introduction into interstate commerce after such effective date.

11. The subsection was added by section 16(a)(2) of Public Law 101–692, which was enacted

November 28, 1990. The subsection was added as subsection (f), and was redesignated as

subsection (g) by section 2(d)(4) of Public Law 102–108.

12. Paragraph (4) was added by section 204(3) of Public Law 107–250 (116 Stat. 1611), which

was enacted October 26, 2002.

13. The amendments made to this Act by the Drug Amendments of 1962 (Public Law 87–781)

included amendments establishing the requirement that new drugs be effective. Section 107(c)

of such Public Law concerned the applicability of the amendments, and is included in the

appendix.

14. Provision was added by title I of Public Law 98–417, which was enacted September 24,

1984.

15. So in law. See section 1101(b)(2)(D) of Public Law 108–173 (117 Stat. 2454). Probably

should be "subsection (b)(3)".

16. See footnote for subsection (c)(2).

17. So in law. Probably should be "bioavailability".

18. Indentation is so in law. See section 15(c) of Public Law 107–109 (115 Stat. 1420).

19. Public Law 108–173, enacted December 8, 2003.

20. This subsection was added by title I of Public Law 98–417, which was enacted September

24, 1984.

21. 1 See footnote for clause (i).

22. See footnote for paragraph (5)(F)(i).

23. 1 See footnote for paragraph (5)(F)(i).

24. Subsection (a) of section 1103 of Public Law 108–173 (117 Stat. 2460) amended

subparagraph (A) of paragraph (8) to read as provided above, and also added to such

paragraph subparagraph (C) (see next page). Subsection (b) of such section 1103 provides as

follows: "The amendment made by subsection (a) does not alter the standards for approval of

drugs under section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)).".

25. Section 16 of Public Law 107–109 (115 Stat. 1421) requires the Comptroller General of the

United States, in consultation with the Secretary of Health and Human Services, to submit to

Congress a report that relates to section 505A and to section 409I of the Public Health Service

Act. The report is required to be submitted not later than October 1, 2006.

26. So in law. There is no section 499 in this Act. The probable intent of the Congress was to

refer to section 499 of the Public Health Service Act, which provides for a Foundation.

27. Probably should be "subsection (b) or (c)". Section 19(4) of Public Law 107–109 (115 Stat.

1424) provided in part that subsection (m) is amended by striking "subsection (a) or (c)" and

inserting ";subsection (b) or (c)". The language to be struck does not appear in subsection (m),

but does appear in subsection (n). (Subsections (m) and (n) were two of 10 subsections

redesignated by section 19(2) of such Public Law.)

28. Section 2 of Public Law 108–155 (117 Stat. 1936) added section 505B above. Section 4 of

such Act (117 Stat. 1942) provides as follows:

SEC. 4. EFFECTIVE DATE.

(a) IN GENERAL.—Subject to subsection (b), this Act and the amendments made by this Act

take effect on the date of enactment of this Act.

(b) APPLICABILITY TO NEW DRUGS AND BIOLOGICAL PRODUCTS.—

(1) IN GENERAL.—Subsection (a) of section 505B of the Federal Food, Drug, and Cosmetic

Act (as added by section 2) shall apply to an application described in paragraph (1) of that

subsection submitted to the Secretary of Health and Human Services on or after April 1, 1999.

(2) WAIVERS AND DEFERRALS.—

(A) WAIVER OR DEFERRAL GRANTED.—If, with respect to an application submitted to the

Secretary of Health and Human Services between April 1, 1999, and the date of enactment of

this Act, a waiver or deferral of pediatric assessments was granted under regulations of the

Secretary then in effect, the waiver or deferral shall be a waiver or deferral under subsection (a)

of section 505B of the Federal Food, Drug, and Cosmetic Act, except that any date specified in

such a deferral shall be extended by the number of days that is equal to the number of days

between October 17, 2002, and the date of enactment of this Act.

(B) WAIVER AND DEFERRAL NOT GRANTED.—If, with respect to an application submitted

to the Secretary of Health and Human Services between April 1, 1999, and the date of

enactment of this Act, neither a waiver nor deferral of pediatric assessments was granted

under regulations of the Secretary then in effect, the person that submitted the application

shall be required to submit assessments under subsection (a)(2) of section 505B of the

Federal Food, Drug, and Cosmetic Act on the date that is the later of—

(i) the date that is 1 year after the date of enactment of this Act; or

(ii) such date as the Secretary may specify under subsection (a)(3) of that section; unless the

Secretary grants a waiver under subsection (a)(4) of that section.

(c) NO LIMITATION OF AUTHORITY.—Neither the lack of guidance or regulations to

implement this Act or the amendments made by this Act nor the pendency of the process for

issuing guidance or regulations shall limit the authority of the Secretary of Health and Human

Services under, or defer any requirement under, this Act or those amendments.

29. Subsection (e) was added by section 506 of Public Law 107–188 (116 Stat. 693). Section

506 was contained in subtitle A of title V of the Public Law, and section 508 of that subtitle

provided that "The amendments made by this subtitle take effect October 1, 2002."

30. Section 507 was struck by section 125(b)(1) of Public Law 105–115 (111 Stat. 2325).

31. The purpose of section 510 was stated in section 301 of Public Law 82–781 as follows:

"SEC. 301. The Congress hereby finds and declares that in order to make regulation of

interstate commerce in drugs effective, it is necessary to provide for registration and inspection

of all establishments in which drugs are manufactured, prepared, propagated, compounded, or

processed; that the products of all such establishments are likely to enter the channels of

interstate commerce and directly affect such commerce; and that the regulation of interstate

commerce in drugs without provision for registration and inspection of establishments that may

be engaged only in intrastate commerce in such drugs would discriminate against and depress

interstate commerce in such drugs, and adversely burden, obstruct, and affect such interstate

commerce."

32. The effective date is February 1, 1973. This subsection was added by Public Law 92–387,

which was enacted August 16, 1972. Section 5 of such Public Law provided that the

amendments made by the Public Law "shall take effect on the first day of the sixth month

beginning after the date of the enactment of this Act.".

CHAPTER V--Drugs and Devices Subchapter A--Drugs and Devices

NEW ANIMAL DRUGS

SEC. 512. 1, 2 [21 U.S.C. 360b] (a)(1) 3 A new animal drug shall, with respect to any particular

use or intended use of such drug, be deemed unsafe for purposes of section 501(a)(5) and

section 402(a)(2)(C)(ii) unless—

(A) there is in effect an approval of an application filed pursuant to subsection (b) with respect

to such use or intended use of such drug, and such drug, its labeling, and such use conform to

such approved application;

(B) there is in effect a conditional approval of an application filed pursuant to section 571 with

respect to such use or intended use of such drug, and such drug, its labeling, and such use

conform to such conditionally approved application; or

(C) there is in effect an index listing pursuant to section 572 with respect to such use or

intended use of such drug in a minor species, and such drug, its labeling, and such use

conform to such index listing.

A new animal drug shall also be deemed unsafe for such purposes in the event of removal

from the establishment of a manufacturer, packer, or distributor of such drug for use in the

manufacture of animal feed in any State unless at the time of such removal such manufacturer,

packer, or distributor has an unrevoked written statement from the consignee of such drug, or

notice from the Secretary, to the effect that, with respect to the use of such drug in animal feed,

such consignee (i) holds a license issued under subsection (m) and has in its possession

current approved labeling for such drug in animal feed; or (ii) will, if the consignee is not a user

of the drug, ship such drug only to a holder of a license issued under subsection (m).

(2) An animal feed bearing or containing a new animal drug shall, with respect to any particular

use or intended use of such animal feed be deemed unsafe for purposes of section 501(a)(6)

unless—

(A) there is in effect—

(i) an approval of an application filed pursuant to subsection (b) with respect to such drug, as

used in such animal feed, and such animal feed and its labeling, distribution, holding, and use

conform to such approved application;

(ii) a conditional approval of an application filed pursuant to section 571 with respect to such

drug, as used in such animal feed, and such animal feed and its labeling, distribution, holding,

and use conform to such conditionally approved application; or

(iii) an index listing pursuant to section 572 with respect to such drug, as used in such animal

feed, and such animal feed and its labeling, distribution, holding, and use conform to such

index listing; and

(B) such animal feed is manufactured at a site for which there is in effect a license issued

pursuant to subsection (m)(1) to manufacture such animal feed.

(3) A new animal drug or an animal feed bearing or containing a new animal drug shall not be

deemed unsafe for the purposes of section 501(a)(5) or (6) if such article is for investigational

use and conforms to the terms of an exemption in effect with respect thereto under section

512(j).

(4) (A) Except as provided in subparagraph (B), if an approval of an application filed under

subsection (b) is in effect with respect to a particular use or intended use of a new animal drug,

the drug shall not be deemed unsafe for the purposes of paragraph (1) and shall be exempt

from the requirements of section 502(f) with respect to a different use or intended use of the

drug, other than a use in or on animal feed, if such use or intended use—

(i) is by or on the lawful written or oral order of a licensed veterinarian within the context of a

veterinarian-client-patient relationship, as defined by the Secretary; and

(ii) is in compliance with regulations promulgated by the Secretary that establish the conditions

for such different use or intended use.

The regulations promulgated by the Secretary under clause (ii) may prohibit particular uses of

an animal drug and shall not permit such different use of an animal drug if the labeling of

another animal drug that contains the same active ingredient and which is in the same dosage

form and concentration provides for such different use.

(B) If the Secretary finds that there is a reasonable probability that a use of an animal drug

authorized under subparagraph (A) may present a risk to the public health, the Secretary

may—

(i) establish a safe level for a residue of an animal drug when it is used for such different use

authorized by subparagraph (A); and

(ii) require the development of a practical, analytical method for the detection of residues of

such drug above the safe level established under clause (i).

The use of an animal drug that results in residues exceeding a safe level established under

clause (i) shall be considered an unsafe use of such drug under paragraph (1). Safe levels

may be established under clause (i) either by regulation or order.

(C) The Secretary may by general regulation provide access to the records of veterinarians to

ascertain any use or intended use authorized under subparagraph (A) that the Secretary has

determined may present a risk to the public health.

(D) If the Secretary finds, after affording an opportunity for public comment, that a use of an

animal drug authorized under subparagraph (A) presents a risk to the public health or that an

analytical method required under subparagraph (B) has not been developed and submitted to

the Secretary, the Secretary may, by order, prohibit any such use.

(5) If the approval of an application filed under section 505 is in effect, the drug under such

application shall not be deemed unsafe for purposes of paragraph (1) and shall be exempt

from the requirements of section 502(f) with respect to a use or intended use of the drug in

animals if such use or intended use—

(A) is by or on the lawful written or oral order of a licensed veterinarian within the context of a

veterinarian-client-patient relationship, as defined by the Secretary; and

(B) is in compliance with regulations promulgated by the Secretary that establish the

conditions for the use or intended use of the drug in animals.

(6) For purposes of section 402(a)(2)(D), a use or intended use of a new animal drug shall not

be deemed unsafe under this section if the Secretary establishes a tolerance for such drug

and any edible portion of any animal imported into the United States does not contain residues

exceeding such tolerance. In establishing such tolerance, the Secretary shall rely on data

sufficient to demonstrate that a proposed tolerance is safe based on similar food safety criteria

used by the Secretary to establish tolerances for applications for new animal drugs filed under

subsection (b)(1). The Secretary may consider and rely on data submitted by the drug

manufacturer, including data submitted to appropriate regulatory authorities in any country

where the new animal drug is lawfully used or data available from a relevant international

organization, to the extent such data are not inconsistent with the criteria used by the

Secretary to establish a tolerance for applications for new animal drugs filed under subsection

(b)(1). For purposes of this paragraph, ‘‘relevant international organization’’ means the Codex

Alimenterius Commission or other international organization deemed appropriate by the

Secretary. The Secretary may, under procedures specified by regulation, revoke a tolerance

established under this paragraph if information demonstrates that the use of the new animal

drug under actual use conditions results in food being imported into the United States with

residues exceeding the tolerance or if scientific evidence shows the tolerance to be unsafe.

(b)(1) Any person may file with the Secretary an application with respect to any intended use

or uses of a new animal drug. Such person shall submit to the Secretary as a part of the

application (A) full reports of investigations which have been made to show whether or not

such drug is safe and effective for use; (B) a full list of the articles used as components of such

drug; (C) a full statement of the composition of such drug; (D) a full description of the methods

used in, and the facilities and controls used for, the manufacture, processing, and packing of

such drug; (E) such samples of such drug and of the articles used as components thereof, of

any animal feed for use in or on which such drug is intended, and of the edible portions or

products (before or after slaughter) of animals to which such drug (directly or in or on animal

feed) is intended to be administered, as the Secretary may require; (F) specimens of the

labeling proposed to be used for such drug, or in case such drug is intended for use in animal

feed, proposed labeling appropriate for such use, and specimens of the labeling for the drug to

be manufactured, packed, or distributed by the applicant; (G) a description of practicable

methods for determining the quantity, if any, of such drug in or on food, and any substance

formed in or on food, because of its use; and (H) the proposed tolerance or withdrawal period

or other use restrictions for such drug if any tolerance or withdrawal period or other use

restrictions are required in order to assure that the proposed use of such drug will be safe. The

applicant shall file with the application the patent number and the expiration date of any patent

which claims the new animal drug for which the applicant filed the application or which claims a

method of using such drug and with respect to which a claim of patent infringement could

reasonably be asserted if a person not licensed by the owner engaged in the manufacture, use,

or sale of the drug. If an application is filed under this subsection for a drug and a patent which

claims such drug or a method of using such drug is issued after the filing date but before

approval of the application, the applicant shall amend the application to include the information

required by the preceding sentence. Upon approval of the application, the Secretary shall

publish information submitted under the two preceding sentences.

(2) Any person may file with the Secretary an abbreviated application for the approval of a new

animal drug. An abbreviated application shall contain the information required by subsection

(n).

(3) Any person intending to file an application under paragraph (1), section 571, or a request

for an investigational exemption under subsection (j) shall be entitled to one or more

conferences prior to such submission to reach an agreement acceptable to the Secretary

establishing a submission or an investigational requirement, which may include a requirement

for a field investigation. A decision establishing a submission or an investigational requirement

shall bind the Secretary and the applicant or requestor unless (A) the Secretary and the

applicant or requestor mutually agree to modify the requirement, or (B) the Secretary by

written order determines that a substantiated scientific requirement essential to the

determination of safety or effectiveness of the animal drug involved has appeared after the

conference. No later than 25 calendar days after each such conference, the Secretary shall

provide a written order setting forth a scientific justification specific to the animal drug and

intended uses under consideration if the agreement referred to in the first sentence requires

more than one field investigation as being essential to provide substantial evidence of

effectiveness for the intended uses of the drug. Nothing in this paragraph shall be construed

as compelling the Secretary to require a field investigation.

(c)(1) Within one hundred and eighty days after the filing of an application pursuant to

subsection (b), or such additional period as may be agreed upon by the Secretary and the

applicant, the Secretary shall either (A) issue an order approving the application if he then

finds that none of the grounds for denying approval specified in subsection (d) applies, or (B)

give the applicant notice of an opportunity for a hearing before the Secretary under subsection

(d) on the question whether such application is approvable. If the applicant elects to accept the

opportunity for a hearing by written request within thirty days after such notice, such hearing

shall commence not more than ninety days after the expiration of such thirty days unless the

Secretary and the applicant otherwise agree. Any such hearing shall thereafter be conducted

on an expedited basis and the Secretary’s order thereon shall be issued within ninety days

after the date fixed by the Secretary for filing final briefs.

(2)(A) Subject to subparagraph (C), the Secretary shall approve an abbreviated application for

a drug unless the Secretary finds—

(i) the methods used in, or the facilities and controls used for, the manufacture, processing,

and packing of the drug are inadequate to assure and preserve its identity, strength, quality,

and purity;

(ii) the conditions of use prescribed, recommended, or suggested in the proposed labeling are

not reasonably certain to be followed in practice or, except as provided in subparagraph (B),

information submitted with the application is insufficient to show that each of the proposed

conditions of use or similar limitations (whether in the labeling or published pursuant to

subsection (i)) have been previously approved for the approved new animal drug referred to in

the application;

(iii) information submitted with the application is insufficient to show that the active ingredients

are the same as those of the approved new animal drug referred to in the application;

(iv)(I) if the application is for a drug whose active ingredients, route of administration, dosage

form, strength, or use with other animal drugs in animal feed is the same as the active

ingredients, route of administration, dosage form, strength, or use with other animal drugs in

animal feed of the approved new animal drug referred to in the application, information

submitted in the application is insufficient to show that the active ingredients, route of

administration, dosage form, strength, or use with other animal drugs in animal feed is the

same as that of the approved new animal drug, or

(II) if the application is for a drug whose active ingredients, route of administration, dosage

form, strength, or use with other animal drugs in animal feed is different from that of the

approved new animal drug referred to in the application, no petition to file an application for the

drug with the different active ingredients, route of administration, dosage form, strength, or use

with other animal drugs in animal feed was approved under subsection (n)(3);

(v) if the application was filed pursuant to the approval of a petition under subsection (n)(3), the

application did not contain the information required by the Secretary respecting the active

ingredients, route of administration, dosage form, strength, or use with other animal drugs in

animal feed which is not the same;

(vi) information submitted in the application is insufficient to show that the drug is bioequivalent

to the approved new animal drug referred to in the application, or if the application is filed

under a petition approved pursuant to subsection (n)(3), information submitted in the

application is insufficient to show that the active ingredients of the new animal drug are of the

same pharmacological or therapeutic class as the pharmacological or therapeutic class of the

approved new animal drug and that the new animal drug can be expected to have the same

therapeutic effect as the approved new animal drug when used in accordance with the

labeling;

(vii) information submitted in the application is insufficient to show that the labeling proposed

for the drug is the same as the labeling approved for the approved new animal drug referred to

in the application except for changes required because of differences approved under a

petition filed under subsection (n)(3), because of a different withdrawal period, or because the

drug and the approved new animal drug are produced or distributed by different

manufacturers;

(viii) information submitted in the application or any other information available to the Secretary

shows that (I) the inactive ingredients of the drug are unsafe for use under the conditions

prescribed, recommended, or suggested in the labeling proposed for the drug, (II) the

composition of the drug is unsafe under such conditions because of the type or quantity of

inactive ingredients included or the manner in which the inactive ingredients are included, or

(III) in the case of a drug for food producing animals, the inactive ingredients of the drug or its

composition may be unsafe with respect to human food safety;

(ix) the approval under subsection (b)(1) of the approved new animal drug referred to in the

application filed under subsection (b)(2) has been withdrawn or suspended for grounds

described in paragraph (1) of subsection (e), the Secretary has published a notice of a hearing