[Congressional Bills 103th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1178 Introduced in House (IH)]

103d CONGRESS
  1st Session
                                H. R. 1178

  To amend the Federal Food, Drug, and Cosmetic Act to allow licensed 
veterinarians to order the extra-label use of drugs in animals, and for 
                            other purposes.


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                    IN THE HOUSE OF REPRESENTATIVES

                             March 2, 1993

Mr. Stenholm (for himself, Mr. Allard, Mr. Andrews of Maine, Mr. Armey, 
   Mr. Baker of Louisiana, Mr. Barrett of Nebraska, Mr. Bartlett of 
  Maryland, Mr. Bereuter, Mr. Boehlert, Mr. Boehner, Mr. Bonilla, Mr. 
Brewster, Mr. Browder, Mr. Brown of California, Mr. Bryant, Mr. Burton 
   of Indiana, Mr. Camp, Mr. Chapman, Mr. Coleman, Mr. Combest, Mr. 
 Condit, Mr. Costello, Mr. Cramer, Mr. Dooley, Mr. Dornan, Mr. Duncan, 
       Mr. Emerson, Mr. Ewing, Mr. Fields of Texas, Mr. Frank of 
Massachusetts, Mr. Frost, Mr. Gallegly, Mr. Gibbons, Mr. Glickman, Mr. 
 Goodling, Mr. Gordon, Mr. Gunderson, Mr. Hall of Texas, Mr. Hamilton, 
  Mr. Hancock, Mr. Hansen, Mr. Hastert, Mr. Hastings, Mr. Hefner, Mr. 
   Hutchinson, Mr. Hutto, Mr. Hyde, Mr. Inhofe, Mr. Johnson of South 
 Dakota, Mr. Kleczka, Mr. Kolbe, Mr. Kopetski, Mr. Kyl, Mr. Lancaster, 
    Mr. Lehman, Mr. Lewis of Florida, Mr. Lightfoot, Ms. Long, Mr. 
McCloskey, Mr. McCrery, Mr. Montgomery, Mr. Neal of North Carolina, Mr. 
Nussle, Mr. Oberstar, Mr. Oxley, Mr. Packard, Mr. Paxon, Mr. Penny, Mr. 
Pickett, Mr. Pomeroy, Mr. Roth, Mr. Rowland, Mr. Royce, Mr. Sarpalius, 
  Mr. Sensenbrenner, Mr. Shaw, Mr. Shays, Ms. Slaughter, Mr. Smith of 
Michigan, Ms. Snowe, Mr. Stump, Mr. Swift, Mr. Tanner, Mr. Torres, Mr. 
Towns, Mrs. Unsoeld, Mr. Upton, Mrs. Vucanovich, Mr. Walsh, Mr. Wilson, 
    Mr. Young of Alaska, Mr. Zeliff, and Mr. Zimmer) introduced the 
   following bill; which was referred to the Committee on Energy and 
                                Commerce

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                                 A BILL


 
  To amend the Federal Food, Drug, and Cosmetic Act to allow licensed 
veterinarians to order the extra-label use of drugs in animals, and for 
                            other purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. AMENDMENTS TO THE FEDERAL FOOD, DRUG, AND COSMETIC ACT.

    (a) Section 512(a) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360b(a)) is amended by adding the following new paragraphs at 
the end:
    ``(4) A new animal drug that is the subject of an approved new 
animal drug application, the use or intended use of which does not 
conform to such approved application, shall not be deemed unsafe for 
the purposes of section 501(a)(5) if such use or intended use of such 
drug is by or upon the lawful prescription or oral order of a licensed 
veterinarian within the context of a veterinarian-client-patient 
relationship and is in compliance with regulations promulgated by the 
Secretary that establish such conditions for such use as may be 
necessary to protect the public health, except that such drug shall be 
deemed unsafe if its use results in residues in food that are above the 
tolerance established for the new animal drug.
    ``(5) When used in nonfood animals, a new drug for human use that 
is the subject of an approved new drug application shall not be deemed 
unsafe for the purposes of section 501(a)(5) and shall be exempt from 
the requirements of section 502(f) if such use or intended use of such 
drug in nonfood animals meets the requirements of paragraph (4).''.
    (b) Section 503 of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 353) is amended by redesignating subsections (c) through (f) as 
subsections (d) through (g).

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