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

Summary

Certain drugs mixed into animal feed can only be given when a licensed veterinarian writes a special feeding order. These drugs are those approved or listed under specific FDA approval or index processes. The veterinarian’s order must include the information the Secretary requires and must match how the drug was approved or listed. If people follow these rules for labeling, selling, storing, and using the feed, the product gets an exception under another federal labeling rule. Definitions: veterinary feed directive drug — a drug put into animal feed that needs a veterinarian’s order; veterinary feed directive — the veterinarian’s written order. Distributors and users must keep copies or acknowledgments, let officials inspect records, and new distributors must notify the government. Labeling or advertising that doesn’t follow the rules makes the product misbranded. These drugs and feeds are not treated as prescription drugs under 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