Laws: Cases and Codes : U.S. Code : Title 21 : Section 354


   
U.S. Code as of: 01/19/04
Section 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 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.

      (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 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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