
From the U.S. Code Online via GPO Access
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[Laws in effect as of January 2, 2001]
[Document not affected by Public Laws enacted between
  January 2, 2001 and January 28, 2002]
[CITE: 21USC354]

 
                        TITLE 21--FOOD AND DRUGS
 
             CHAPTER 9--FEDERAL FOOD, DRUG, AND COSMETIC ACT
 
                     SUBCHAPTER V--DRUGS AND DEVICES
 
                        Part A--Drugs and Devices
 
Sec. 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.

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


                            Prior Provisions

    A prior section 354, act June 25, 1938, ch. 675, Sec. 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, 
Sec. 103(a)(2), title II, Sec. 202, July 12, 1960, 74 Stat. 398, 404.

                  Section Referred to in Other Sections

    This section is referred to in sections 331, 360b of this title.
