I

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.

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

A BILL

To amend the Federal Food, Drug, and Cosmetic Act to
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HR 1178 IH

allow licensed veterinarians to order the extra-label use

of drugs in animals, and for other purposes.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,

3 SECTION 1. AMENDMENTS TO THE FEDERAL FOOD, DRUG,

4 AND COSMETIC ACT.

5 (a) Section 512(a) of the Federal Food, Drug, and

6 Cosmetic Act (21 U.S.C. 360b(a)) is amended by adding

7 the following new paragraphs at the end:

8 ‘‘(4) A new animal drug that is the subject of an ap9 proved new animal drug application, the use or intended

10 use of which does not conform to such approved applica11 tion, shall not be deemed unsafe for the purposes of sec12 tion 501(a)(5) if such use or intended use of such drug

13 is by or upon the lawful prescription or oral order of a

14 licensed veterinarian within the context of a veterinarian15 client-patient relationship and is in compliance with regu16 lations promulgated by the Secretary that establish such

17 conditions for such use as may be necessary to protect

18 the public health, except that such drug shall be deemed

19 unsafe if its use results in residues in food that are above

20 the tolerance established for the new animal drug.

21 ‘‘(5) When used in nonfood animals, a new drug for

22 human use that is the subject of an approved new drug

23 application shall not be deemed unsafe for the purposes

24 of section 501(a)(5) and shall be exempt from the require-
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HR 1178 IH

1 ments of section 502(f) if such use or intended use of such

2 drug in nonfood animals meets the requirements of para3 graph (4).’’.

4 (b) Section 503 of the Federal Food, Drug, and Cos5 metic Act (21 U.S.C. 353) is amended by redesignating

6 subsections (c) through (f) as subsections (d) through (g).

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