§ 354. Veterinary feed directive drugs

Legislative history

Reconstructed from this section’s Code source credit and amendment notes, resolved against the local Statutes at Large. Editorial notes are evidence, not the law that made the change.

1. 1938

   Animal Drug Availability Act of 1996

   Pub. L. 104–250 § 5(b) · 110 Stat. 3151

   Enacted · 21 U.S.C. § 354

   June 25, 1938, ch. 675, § 504, as added Pub. L. 104–250, § 5(b), Oct. 9, 1996, 110 Stat. 3155

   Source evidence

   Code source credit
   June 25, 1938, ch. 675, § 504, as added Pub. L. 104–250, § 5(b), Oct. 9, 1996, 110 Stat. 3155

   Enacted provision · exact public law section
   (b) Section 504.— The Federal Food, Drug, and Cosmetic Act is amended by inserting after section 503 the following: “Sec. 504. “veterinary feed directive drugs (a) (1) A drug intended for use in or on animal 21 USC 354. feed which is limited by an approved application filed pursuant to section 512(b) 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 502(f). “(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 512(i). “(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 512(i) 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,”.

2. 2004

   Minor Use and Minor Species Animal Health Act of 2004

   Pub. L. 108–282 § 102(b)(5)(G) · 118 Stat. 891

   Substituted · 21 U.S.C. § 354(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”

   Source evidence

   Code amendment note
   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”.

   Enacted provision · exact public law section
   (G) Section 504(a)(1) of the Federal Food, Drug, and Cosmetic Act is 21 USC 354. amended by striking “512(b)” and inserting “512(b), a conditionally-approved application filed pursuant to section 571, or an index listing pursuant to section 572”.

3. 2004

   Minor Use and Minor Species Animal Health Act of 2004

   Pub. L. 108–282 § 102(b)(5)(H) · 118 Stat. 891

   Substituted · 21 U.S.C. § 354(a)(2)(B); 21 U.S.C. § 354(a)(2)(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”

   Source evidence

   Code amendment note
   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”.

   Enacted provision · exact public law section
   (H) Sections 504(a)(2)(B) and 504(b) of the Federal Food, Drug, and Cosmetic Act are amended by striking “512(i)” each place it appears and inserting “512(i), or the index listing pursuant to section 572(e)”.

3 of 3 references resolved to an enrolled provision