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21 U.S.C. § 392 — Exemption of meats and meat food products

Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 392 — Exemption of meats and meat food products

**(a) Law determinative of exemption** Meats and meat food products shall be exempt from the provisions of this chapter to the extent of the application or the extension thereto of the Meat Inspection Act, approved March 4, 1907, as amended [[21 U.S.C. 601](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section601&num=0&edition=prelim) et seq.]. **(b) Laws unaffected** Nothing contained in this chapter shall be construed as in any way affecting, modifying, repealing, or superseding the provisions of section 351 of Public Health Service Act [[42 U.S.C. 262](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim)] (relating to viruses, serums, toxins, and analogous products applicable to man); the virus, serum, toxin, and analogous products provisions, applicable to domestic animals, of the Act of Congress approved March 4, 1913 (37 Stat. 832–833) [[21 U.S.C. 151](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section151&num=0&edition=prelim) et seq.]; the Filled Cheese Act of June 6, 1896 (U.S.C., 1934 ed., title 26, ch. 10), the Filled Milk Act of March 4, 1923 [[21 U.S.C. 61](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section61&num=0&edition=prelim) et seq.]; or the Import Milk Act of February 15, 1927 [[21 U.S.C. 141](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section141&num=0&edition=prelim) et seq.].

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Source location: Title 21, Chapter 9, § 392; chapter-009-federal-food-drug-and-cosmetic-act.md

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 301 — Short title

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

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 141 — Prohibition of importation without permit

On and after May 16, 1927, the importation into the United States of milk and cream is prohibited unless the person by whom such milk or cream is shipped or transported into the United States holds a valid permit from the Secretary of Health and Human Services.

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 360b — New animal drugs

**(a) Unsafe new animal drugs and animal feed containing such drugs; conditions of safety; exemption of drugs for research; import tolerances** (1) A new animal drug shall, with respect to any particular use or intended use of such drug, be deemed unsafe for purposes of [section 351(a)(5) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section351/a/5&num=0&edition=prelim) and [section 342(a)(2)(C)(ii) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section342/a/2/C/ii&num=0&edition=prelim) 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 360ccc of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360ccc&num=0&edition=prelim) 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; (C) there is in effect an index listing pursuant to [section 360ccc–1 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360ccc-1&num=0&edition=prelim) 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; or (D) there is in effect an authorization pursuant to [section 360bbb–3 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360bbb-3&num=0&edition=prelim) with respect to such use or intended use of such drug, and such drug, its labeling, and su

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Federal law — U.S. Code and appendices · legal_authorities

42 U.S.C. § 262 — Regulation of biological products

**(a) Biologics license** (1) No person shall introduce or deliver for introduction into interstate commerce any biological product unless— (A) a biologics license under this subsection or subsection (k) is in effect for the biological product; and (B) each package of the biological product is plainly marked with— (i) the proper name of the biological product contained in the package; (ii) the name, address, and applicable license number of the manufacturer of the biological product; and (iii) the expiration date of the biological product. (2) (A) The Secretary shall establish, by regulation, requirements for the approval, suspension, and revocation of biologics licenses. (B) *Pediatric studies.—* — A person that submits an application for a license under this paragraph shall submit to the Secretary as part of the application any assessments required under section 505B of the Federal Food, Drug, and Cosmetic Act [[21 U.S.C. 355c](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355c&num=0&edition=prelim)]. (C) The Secretary shall approve a biologics license application— (i) on the basis of a demonstration that— (I) the biological product that is the subject of the application is safe, pure, and potent; and (II) the facility in which the biological product is manufactured, processed, packed, or held meets standards designed to assure that the biological product continues to be safe, pure, and potent; and (ii) if the applicant (or other appropriate person) consents to the inspection of the facility that is the subject of the application, in accordance with subsection (c). (D) *Postmarket studies and clinical trials; labeling; risk evaluation and mitigation strategy.—* — A person that sub

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 61 — Definitions

Whenever used in this chapter— **(a)** The term “person” includes an individual, partnership, corporation, or association; **(b)** The term “interstate or foreign commerce” means commerce (1) between any State, Territory, or possession, or the District of Columbia, and any place outside thereof; (2) between points within the same State, Territory, or possession, or within the District of Columbia, but through any place outside thereof; or (3) within any Territory or possession, or within the District of Columbia; and **(c)** The term “filled milk” means any milk, cream, or skimmed milk, whether or not condensed, evaporated, concentrated, powdered, dried, or desiccated, to which has been added, or which has been blended or compounded with, any fat or oil other than milk fat, so that the resulting product is in imitation or semblance of milk, cream, or skimmed milk, whether or not condensed, evaporated, concentrated, powdered, dried, or desiccated. This definition shall not include any distinctive proprietary food compound not readily mistaken in taste for milk or cream or for evaporated, condensed, or powdered milk, or cream where such compound (1) is prepared and designed for feeding infants and young children and customarily used on the order of a physician; (2) is packed in individual cans containing not more than sixteen and one-half ounces and bearing a label in bold type that the content is to be used only for said purpose; (3) is shipped in interstate or foreign commerce exclusively to physicians, wholesale and retail druggists, orphan asylums, child-welfare associations, hospitals, and similar institutions and generally disposed of by them.

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 601 — Definitions

As used in this chapter, except as otherwise specified, the following terms shall have the meanings stated below: **(a)** The term “Secretary” means the Secretary of Agriculture of the United States or his delegate. **(b)** The term “firm” means any partnership, association, or other unincorporated business organization. **(c)** The term “meat broker” means any person, firm, or corporation engaged in the business of buying or selling carcasses, parts of carcasses, meat, or meat food products of cattle, sheep, swine, goats, horses, mules, or other equines on commission, or otherwise negotiating purchases or sales of such articles other than for his own account or as an employee of another person, firm, or corporation. **(d)** The term “renderer” means any person, firm, or corporation engaged in the business of rendering carcasses or parts or products of the carcasses, of cattle, sheep, swine, goats, horses, mules, or other equines, except rendering conducted under inspection or exemption under this subchapter. **(e)** The term “animal food manufacturer” means any person, firm, or corporation engaged in the business of manufacturing or processing animal food derived wholly or in part from carcasses, or parts or products of the carcasses, of cattle, sheep, swine, goats, horses, mules, or other equines. **(f)** The term “State” means any State of the United States and the Commonwealth of Puerto Rico. **(g)** The term “Territory” means Guam, the Virgin Islands of the United States, American Samoa, and any other territory or possession of the United States, excluding the Canal Zone. **(h)** The term “commerce” means commerce between any State, any Territory, or the District of Columbia, and any place outside thereof; or within any Territory not organized with a legisl

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 151 — Preparation and sale of worthless or harmful products for domestic animals prohibited; preparation to be in compliance with rules at licensed establishments

It shall be unlawful for any person, firm, or corporation to prepare, sell, barter, or exchange in the District of Columbia, or in the Territories, or in any place under the jurisdiction of the United States, or to ship or deliver for shipment in or from the United States, the District of Columbia, any territory of the United States, or any place under the jurisdiction of the United States, any worthless, contaminated, dangerous, or harmful virus, serum, toxin, or analogous product intended for use in the treatment of domestic animals, and no person, firm, or corporation shall prepare, sell, barter, exchange, or ship as aforesaid any virus, serum, toxin, or analogous product manufactured within the United States and intended for use in the treatment of domestic animals, unless and until the said virus, serum, toxin, or analogous product shall have been prepared, under and in compliance with regulations prescribed by the Secretary of Agriculture, at an establishment holding an unsuspended and unrevoked license issued by the Secretary of Agriculture as hereinafter authorized.

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 387b — Adulterated tobacco products

A tobacco product shall be deemed to be adulterated if— (1) it consists in whole or in part of any filthy, putrid, or decomposed substance, or is otherwise contaminated by any added poisonous or added deleterious substance that may render the product injurious to health; (2) 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; (3) its package is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; (4) the manufacturer or importer of the tobacco product fails to pay a user fee assessed to such manufacturer or importer pursuant to [section 387s of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section387s&num=0&edition=prelim) by the date specified in [section 387s of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section387s&num=0&edition=prelim) or by the 30th day after final agency action on a resolution of any dispute as to the amount of such fee; (5) it is, or purports to be or is represented as, a tobacco product which is subject to a tobacco product standard established under [section 387g of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section387g&num=0&edition=prelim) unless such tobacco product is in all respects in conformity with such standard; (6) (A) it is required by [section 387j(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section387j/a&num=0&edition=prelim) to have premarket review and does not have an order in effect under [section 387j(c)(1)(A)(i) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 141 — Prohibition of importation without permit

Page 14 TITLE 21—FOOD AND DRUGS § 141 SUBCHAPTER IV—IMPORTATION OF MILK AND CREAM Statutory Notes and Related Subsidiaries FEDERAL FOOD, DRUG, AND COSMETIC ACT Nothing contained in chapter 9 (§ 301 et seq.) of this title shall be construed as in any way affecting, modi- fying, repealing, or superseding the provisions of this subchapter, see section 392(b) of this title. § 141. Prohibition of importation without permit On and after May 16, 1927, the importation into the United States of milk and cream is prohib- ited unless the person by whom such milk or cream is shipped or transported into the United States holds a valid permit from the Secretary of Health and Human Services. (Feb. 15, 1927, ch. 155, § 1, 44 Stat. 1101; 1940 Reorg. Plan No. IV, § 12, eff. June 30, 1940, 5 F.R. 2421, 54 Stat. 1237; 1953 Reorg. Plan No. 1, § 5, eff. Apr. 11, 1953, 18 F.R. 2053, 67 Stat. 631; Pub. L. 96–88, title V, § 509(b), Oct. 17, 1979, 93 Stat. 695.) Statutory Notes and Related Subsidiaries CHANGE OF NAME ‘‘Secretary of Health and Human Services’’ sub- stituted in text for ‘‘Secretary of Health, Education, and Welfare’’ pursuant to section 509(b) of Pub. L. 96–88, which is classified to section 3508(b) of Title 20, Edu- cation. SHORT TITLE Act July 12, 1943, ch. 221, title II, 57 Stat. 499, pro- vided in part that act Feb. 15, 1927, which is classified to this subchapter, may be cited as ‘‘Import Milk Act’’. Executive Documents TRANSFER OF FUNCTIONS For transfer of functions of Federal Security Admin- istrator to Secretary of Health, Education, and Welfare [now Health and Human Services], and of Food and Drug Administration to Federal Security Agency, see notes set out under section 321 of this title. § 142. Milk or cream when unfit for importation Milk

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 151 — Preparation and sale of worthless or harm-

Page 16 TITLE 21—FOOD AND DRUGS § 151 (b) The term ‘‘United States’’ means the fifty States and the District of Columbia. (Feb. 15, 1927, ch. 155, § 9, 44 Stat. 1103; Pub. L. 86–70, § 19, June 25, 1959, 73 Stat. 145; Pub. L. 86–624, § 15, July 12, 1960, 74 Stat. 415.) Editorial Notes AMENDMENTS 1960—Subsec. (b). Pub. L. 86–624 substituted ‘‘means the fifty States and the District of Columbia’’ for ‘‘means continental United States, including Alaska’’. 1959—Subsec. (b). Pub. L. 86–70 inserted ‘‘, including Alaska’’ after ‘‘continental United States’’. CHAPTER 5—VIRUSES, SERUMS, TOXINS, ANTITOXINS, AND ANALOGOUS PRODUCTS Sec. 151. Preparation and sale of worthless or harmful products for domestic animals prohibited; preparation to be in compliance with rules at licensed establishments. 152. Importation regulated and prohibited. 153. Inspection of imports; denial of entry and de- struction. 154. Regulations for preparation and sale; li- censes. 154a. Special licenses for special circumstances; ex- pedited procedure; conditions; exemptions; criteria. 155. Permits for importation. 156. Licenses conditioned on permitting inspec- tion; suspension of licenses. 157. Inspection. 158. Offenses; punishment. 159. Enforcement; penalties applicable; Congres- sional findings. Statutory Notes and Related Subsidiaries FEDERAL FOOD, DRUG, AND COSMETIC ACT Nothing contained in chapter 9 (§ 301 et seq.) of this title shall be construed as in any way affecting, modi- fying, repealing, or superseding the provisions of this chapter, see section 392(b) of this title. § 151. Preparation and sale of worthless or harm- ful products for domestic animals prohibited; preparation to be in compliance with rules at licensed establishments It shall be unlawful

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