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I

Sec.

FOOD AND DRUG ADMINISTRATION

Federal Food, Drug, and Cosmetic Act, As Amended

1. Short title [301]*.

CONTENTS

CHAPTER I-SHORT TITLE

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CHAPTER II-DEFINITIONS

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305. Hearing before report of criminal violation [335]..

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306. Report of minor violations [336]---

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307. Proceedings in name of United States; provision as to subpoenas [337].

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405. Regulations making exemptions [345]-

406. Tolerances for poisonous ingredients in food [346]

407. Oleomargarine or margarine [347]...

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408. Tolerances for pesticide chemicals in or on raw agricultural commodities [346a]...

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409. Food additives [348]-

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Sec.

508. Authority to designate official names [358]509. Nonapplicability to cosmetics [359]--

510. Registration of producers and certain wholesalers of drugs [360]511. Depressant and stimulant drugs [361]--

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706. Listing and certification of color additives for foods, drugs, and cosmetics [376]___

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707. Revision of U.S. Pharmacopeia; development of analysis and mechanical and physical tests [377].

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2. Definitions [1261]†-.

3. Regulations declaring hazardous substances and establishing variations and exemptions [1262]

4. Prohibited acts [1263]-.

5. Penalties [1264]-

6. Seizures [1265]--

7. Hearing before report of criminal violation [1266]_

8. Injunctions [1267]-.

10. Regulations [1269]

11. Examinations andinvestigations [1270]-

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† References in brackets [ ] are to title 15 U.S. Code.

9. Style of enforcement proceedings-subpoenas [1268]

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12. Records of interstate shipment [1271]

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FEDERAL FOOD, DRUG, AND COSMETIC ACT, AS AMENDED

CHAPTER I-SHORT TITLE

SECTION 1. This Act may be cited as the Federal Food, Drug, and Cosmetic Act.

CHAPTER II-DEFINITIONS

SEC. 201 [321]. For the purposes of this Act

(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 U.S. Department of Health, Education, and Welfare.

(d) The term "Secretary" means the Secretary of Health, Education, and Welfare.

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

(f) 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); but does not include devices or their components, parts, or accessories.

(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.

References in brackets [ ] are to title 21 U.S. Code.

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