§354 — Title 21 Food and Drugs | U.S. Code

Summary

Drugs that may be put into animal feed but only used under a veterinarian’s supervision are called veterinary feed directive (VFD) drugs. Feed that has a VFD drug in it may only be given to animals when a licensed veterinarian issues a lawful VFD during their normal practice. A drug is a VFD if its approval, conditional approval, or index listing limits it to use under a veterinarian’s supervision (see sections 360b(b), 360ccc, and 360ccc–1). When these drugs and feeds are labeled, handled, and used the way this law requires, they are exempt from section 352(f). A lawful VFD must include any information the Secretary requires and must follow the approved conditions and uses published under section 360b(i) or the index listing under section 360ccc–1(e). Veterinarians and people who make, sell, or use feed with VFD drugs must keep a copy of the VFD for each feed. A distributor who ships feed to another distributor must get a written promise from the buyer that they will not send the feed to an animal production site without a VFD and will pass the same promise on if they ship it again. People who must keep these records must let a Secretary-designated officer inspect and copy them at reasonable times. Anyone who starts distributing such feed must tell the Secretary their name and business location; failing to do so makes the drug misbranded. If labels or ads lack the required caution or do not match the approved uses in section 360b(i) or 360ccc–1(e), the drug or feed is misbranded. These drugs and feeds are not treated as prescription articles under any Federal or State law.

Title 21, §354

Food and Drugs — Source: USLM XML via OLRC

(a)(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 pursuant 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 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.

(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, or the index listing pursuant to section 360ccc–1(e) of this title.

(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 360b(i) of this title, or the index listing pursuant to section 360ccc–1(e) of this title 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.

Notes & Related Subsidiaries

Editorial Notes

Prior Provisions

A prior section 354, act June 25, 1938, ch. 675, § 504, 52 Stat. 1052, which directed Secretary to promulgate

Regulations

for listing of coal-tar colors, was repealed effective

July 12, 1960, subject to provisions of section 203 of Pub. L. 86–618, by Pub. L. 86–618, title I, § 103(a)(2), title II, § 202,

July 12, 1960, 74 Stat. 398, 404.

Amendments

2004—Subsec. (a)(1). Pub. L. 108–282, § 102(b)(5)(G), substituted “360b(b) of this title, a conditionally-approved application filed pursuant to section 360ccc of this title, or an index listing pursuant to section 360ccc–1 of this title” for “360b(b) of this title”. Subsecs. (a)(2)(B), (b). Pub. L. 108–282, § 102(b)(5)(H), substituted “360b(i) of this title, or the index listing pursuant to section 360ccc–1(e) of this title” for “360b(i) of this title”.

§354 Veterinary Feed Directive Drugs