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

submitted 88 years ago by Pub. L. 104-250 to r/title-21-FOOD-AND-DRUGS · 566 words · no verdicts yet

in plain englishAI-generated · not legal advice

This law lets certain animal drugs be added to feed only under a licensed veterinarian's written order, called a veterinary feed directive. People who distribute or use this feed must keep records and follow the directive's terms. The feed isn't treated as a prescription drug under other laws.

(a) Lawful veterinary feed directive requirement. (1) A drug meant for use in animal feed that's approved — or conditionally approved, or listed on an index — only for use under a licensed veterinarian's supervision is called a "veterinary feed directive drug." Feed containing it may only be fed to animals under a lawful directive written by a licensed veterinarian acting within their normal professional practice. When the drug and the feed containing it are labeled, distributed, held, and used according to this section, they're excused from the general misbranding rule in section 352(f). (2) A directive is lawful if it (A) contains whatever information the Secretary requires by regulation or order, and (B) matches the approved conditions and uses for the drug published under section 360b(i), or the index listing under section 360ccc–1(e). (3)(A) Everyone involved in distributing or using the feed, and the veterinarian who wrote the directive, must keep a copy of it for each feed — except a person who distributes the feed on to someone else for further distribution. That person must instead keep a written acknowledgment from the receiver promising not to ship the feed to a farm without a valid directive, and not to ship it on to anyone else unless that person gives the same written promise to their own supplier. (B) Anyone required to keep these records, and anyone in charge of them, must let an officer or employee the Secretary designates inspect, copy, and verify the records at reasonable times, on request. (C) Anyone who starts distributing this kind of feed must notify the Secretary of their name and business address. Failing to give that notice makes the drug misbranded. (b) Labeling and advertising. The drug and any feed containing it are treated as misbranded if their label lacks the warning statements and other information the Secretary requires by regulation or order, or if their advertising doesn't match the approved conditions and uses published under section 360b(i) or the index listing under section 360ccc–1(e), or lacks the general warning statement the Secretary prescribes. (c) Nonprescription status. Even though it requires a veterinarian's authorization, this drug — and any animal feed containing it — is not treated as a prescription drug under any federal or state law.
the actual law source: uscode.house.gov ↗public domain
(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 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) 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, 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) 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.

Source credit: (June 25, 1938, ch. 675, § 504, as added Pub. L. 104–250, § 5(b), Oct. 9, 1996, 110 Stat. 3155; amended Pub. L. 108–282, title I, § 102(b)(5)(G), (H), Aug. 2, 2004, 118 Stat. 903.)

history & why it existsrecord from the source credit
  • 1938Enacted · Pub. L. 104-250 · 110 Stat. 3155
  • 2004Amended · Pub. L. 108-282 · 118 Stat. 903

A history note hasn’t been published yet. The record shows enactment by Pub. L. 104-250 on 1938-06-25.

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