I

103D CONGRESS

1ST SESSION H. R. 1423

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 18, 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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HR 1423 IH

A BILL

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

3 SECTION 1. SHORT TITLE.

4 This act may be cited as the ‘‘Animal Medicinal Drug

5 Use Clarification Act of 1993’’.

6 SEC. 2. FINDINGS.

7 Congress finds that—

8 (1) the Federal Food, Drug, and Cosmetic Act

9 currently permits the use of an animal drug, or a

10 drug intended for human use, that is approved by

11 the Food and Drug Administration, only in accord12 ance with the specific labeling approved for the drug;

13 (2) there are not such approved animal drugs

14 available to relieve pain and suffering, or to treat

15 every specific disease or condition found, in each

16 species of animal;

17 (3) it is sometimes necessary for veterinarians

18 to use such an approved animal drug or approved

19 drug intended for human use in a manner that is

20 not in accordance with the label of the drug if—

21 (A) the health of an animal is immediately

22 threatened; and
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HR 1423 IH

1 (B) suffering or death would result from

2 failure to provide effective treatment; and

3 (4) duly licensed veterinarians possess the pro4 fessional training and medical judgment to admin5 ister drugs in a clinically appropriate manner that

6 benefits animals and safeguards the public health.

7 SEC. 3. PURPOSES.

8 The purposes of this Act are—

9 (1) to permit veterinarians to use such an ap10 proved animal drug, or approved drug intended for

11 human use, for therapeutic purposes in animals in

12 a manner that is not specified on the label of the

13 drug, if a valid veterinarian-client-patient relation14 ship exists; and

15 (2) to permit the Secretary of Health and

16 Human Services to establish conditions for such use

17 as may be necessary to protect the public health.

18 SEC. 4. ALTERNATE USES.

19 Section 512(a) of the Federal Food, Drug, and Cos20 metic Act (21 U.S.C. 360b(a)) is amended by adding at

21 the end the following new paragraphs:

22 ‘‘(4)(A) Except as provided in subparagraph

23 (B), if an approval of an application filed under sub24 section (b) is in effect with respect to a particular

25 use or intended use of a new animal drug, the drug
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1 shall not be deemed unsafe for the purposes of sec2 tion 501(a)(5), and shall be exempt from the re3 quirements of section 502(f), with respect to a dif4 ferent use or intended use of the drug, if such use

5 or intended use—

6 ‘‘(i) is by or on the lawful written or oral

7 order of a licensed veterinarian within the con8 text of a veterinarian-client-patient relationship,

9 as defined by the Secretary; and

10 ‘‘(ii) is in compliance with regulations pro11 mulgated by the Secretary under subparagraph

12 (C).

13 ‘‘(B) Notwithstanding subparagraph (A), if the

14 use of a new animal drug results in residues in food

15 that the Secretary has determined to be in violation

16 of established safe levels for such drug, such drug

17 shall then be deemed unsafe for the purposes of sec18 tion 501(a)(5), and shall be subject to the require19 ments of section 502(f).

20 ‘‘(C) The Secretary shall implement final regu21 lations that establish the conditions for the use or

22 intended use of new animal drugs, as provided under

23 this paragraph and as may be necessary to protect

24 the public health, not later than one year after the

25 enactment of this Act.
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1 ‘‘(5)(A) If an approval of an application filed

2 under section 505 is in effect with respect to a par3 ticular use or intended use of a drug intended for

4 human use, the drug shall not be deemed unsafe for

5 the purposes of section 501(a)(5), and shall be ex6 empt from the requirements of section 502(f), with

7 respect to a use or intended use of the drug in

8 nonfood producing animals, if such use or intended

9 use—

10 ‘‘(i) is by or on the lawful written or oral

11 order of a licensed veterinarian within the con12 text of a veterinarian-client-patient relationship,

13 as defined by the Secretary; and

14 ‘‘(ii) is in compliance with regulations pro15 mulgated by the Secretary under subparagraph

16 (B).

17 ‘‘(B) The Secretary shall implement final regu18 lations that establish the conditions for the use or

19 intended use of human drugs, as provided under this

20 paragraph and as may be necessary to protect the

21 public health, not later than one year after the en22 actment of this Act.’’.

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