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21 U.S.C. § 354 — Veterinary feed directive drugs

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

21 U.S.C. § 354 — Veterinary feed directive drugs

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Stable record: federal_law:legal_authorities:record_usc_647798489f9339b3c33edc8b
Source file: Laws/federal/codes/united-states-code/title-21/section-354-veterinary-feed-directive-drugs--308c1b0c08.md
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Source location: Title 21, Chapter 9, § 354; chapter-009-federal-food-drug-and-cosmetic-act.md

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**(a) Lawful veterinary feed directive requirement** (1) A drug intended for use in or on animal feed which is limited by an approved application filed pursuant to [section 360b(b) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360b/b&num=0&edition=prelim), a conditionally-approved 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), or 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) 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 352(f) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section352/f&num=0&edition=prelim). (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 360b(i) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360b/i&num=0&edition=prelim), or the index listing pursuant to [section 360ccc–1(e) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360ccc–1/e&num=0&edition=prelim). (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) Labeling and advertising** 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 360b(i) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360b/i&num=0&edition=prelim), or the index listing pursuant to [section 360ccc–1(e) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360ccc–1/e&num=0&edition=prelim) or fails to contain the general cautionary statement prescribed by the Secretary. **(c) Nonprescription status** 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.

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

21 U.S.C. § 360ccc — Conditional approval of new animal drugs for minor use and minor species and certain new animal drugs

**(a) Application requirements** (1) (A) Except as provided in paragraph (3), any person may file with the Secretary an application for conditional approval of— (i) a new animal drug intended for a minor use or a minor species; or (ii) a new animal drug not intended for a minor use or minor species— (I) that is intended to treat a serious or life-threatening disease or condition or addresses an unmet animal or human health need; and (II) for which the Secretary determines that a demonstration of effectiveness would require a complex or particularly difficult study or studies. (B) The Secretary shall, not later than September 30, 2019, issue guidance or regulations further clarifying the criteria specified in subparagraph (A)(ii). (C) An application under this paragraph shall comply in all respects with the provisions of [section 360b of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360b&num=0&edition=prelim) except for subsections (a)(4), (b)(2), (c)(1), (c)(2), (c)(3), (d)(1), (e), (h), and (n) of such section unless otherwise stated in this section, and any additional provisions of this section. (D) New animal drugs for which conditional approval is sought under this section are subject to the same safety standards that would be applied to new animal drugs under [section 360b(d) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360b/d&num=0&edition=prelim) (including, for antimicrobial new animal drugs, with respect to antimicrobial resistance). (2) The applicant shall submit to the Secretary as part of an application for the conditional approval of a new animal drug— (A) all information necessary to meet the requirements of [section 360b(b)(1) o

Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 360ccc

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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.

Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 301

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

21 U.S.C. § 351 — Adulterated drugs and devices

A drug or device shall be deemed to be adulterated— **(a) Poisonous, insanitary, etc., ingredients; adequate controls in manufacture** (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 chapter 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 chapter 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 379e(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:

Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 351

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

21 U.S.C. § 360bbb–3 — Authorization for medical products for use in emergencies

**(a) In general** (1) **Emergency uses** — Notwithstanding any provision of this chapter and section 351 of the 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)], and subject to the provisions of this section, the Secretary may authorize the introduction into interstate commerce, during the effective period of a declaration under subsection (b), of a drug, device, or biological product intended for use in an actual or potential emergency (referred to in this section as an “emergency use”). (2) **Approval status of product** — An authorization under paragraph (1) may authorize an emergency use of a product that— (A) is not approved, licensed, or cleared for commercial distribution under section 355, 360(k), 360b, or 360e of this title or section 351 of the 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)] or conditionally approved under [section 360ccc of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360ccc&num=0&edition=prelim) (referred to in this section as an “unapproved product”); or (B) is approved, conditionally approved under [section 360ccc of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360ccc&num=0&edition=prelim), licensed, or cleared under such a provision, but which use is not under such provision an approved, conditionally approved under [section 360ccc of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360ccc&num=0&edition=prelim), licensed, or cleared use of the product (referred to in this section as an “unapproved use of an approved

Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 360bbb–3

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

21 U.S.C. § 354 — Veterinary feed directive drugs

Page 185 TITLE 21—FOOD AND DRUGS § 354 proved application under section 355(j) of this title to maintain its labeling in accordance with existing requirements, including subpart B of part 201 and sections 314.70 and 314.97 of title 21, Code of Federal Regulations (or any successor regulations). (j) Reports Not later than 4 years after December 27, 2020, and every 4 years thereafter, the Secretary shall prepare and submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate, a report that— (1) describes the actions of the Secretary under this section, including— (A) the number of covered drugs and de- scription of the types of drugs the Secretary has selected for labeling changes and the ra- tionale for such recommended changes; and (B) the number of times the Secretary en- tered into discussions concerning a disagree- ment with an application holder or holders and a summary of the decision regarding a labeling change, if any; and (2) includes any recommendations of the Secretary for modifying the program under this section. (June 25, 1938, ch. 675, § 503D, as added Pub. L. 116–260, div. BB, title III, § 324, Dec. 27, 2020, 134 Stat. 2933.) § 354. Veterinary feed directive drugs (a) Lawful veterinary feed directive requirement (1) A drug intended for use in or on animal feed which is limited by an approved application filed pursuant to section 360b(b) of this title, a conditionally-approved application filed pursu- ant to section 360ccc of this title, or an index listing pursuant to section 360ccc–1 of this title to use under the professional supervision of a li- censed veterinarian is a veterinary feed direc- tive drug. Any animal feed bearing or c

Source: Supplied 2024 U.S. Code historical extraction · 21 U.S.C. § 354

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