I

103D CONGRESS

2D SESSION H. R. 5056

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

SEPTEMBER 19, 1994

Mr. STENHOLM (for himself, Mr. WAXMAN, and Mr. DINGELL) 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

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. SHORT TITLE.

4 This Act may be cited as the ‘‘Animal Drug Amend5 ments of 1994’’.

6 SEC. 2. UNAPPROVED USES

7 (a) GENERAL RULE.—Section 512(a) of the Federal

8 Food, Drug, and Cosmetic Act (21 U.S.C. 360b(a)) is
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1 amended by adding the following new paragraphs at the

2 end:

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

4 (B), if an approval of an application filed under sub5 section (b) is in effect with respect to a particular

6 use or intended use of a new animal drug, the drug

7 shall not be deemed unsafe for the purposes of para8 graph (1) and shall be exempt from the require9 ments of section 502(f) with respect to a different

10 use or intended use of the drug, other than a use

11 in or on animal feed, if such use or intended use—

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

13 order of a licensed veterinarian within the con14 text of a veterinarian-client-patient relationship,

15 as defined by the Secretary; and

16 ‘‘(ii) is in compliance with regulations pro17 mulgated by the Secretary that establish the

18 conditions for such different use or intended

19 use.

20 Regulations under clause (ii) may prohibit particular

21 uses of an animal drug and shall not permit such

22 different use of an animal drug if the labeling of an23 other animal drug which contains the same active in24 gredient and which is in the same dosage form and

25 concentration provides for such different use.
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1 ‘‘(B) If the Secretary finds that there is a rea2 sonable probability that a use of an animal drug au3 thorized under subparagraph (A) may present a risk

4 to the public health, the Secretary may—

5 ‘‘(i) establish a safe level for a residue of

6 an animal drug when it is used for such dif7 ferent use authorized by subparagraph (A); and

8 ‘‘(ii) require the development of a prac9 tical, analytical method for the detection of resi10 dues of the drug above the safe level established

11 under clause (i).

12 The use of an animal drug which results in residues

13 exceeding a safe level established under clause (i)

14 shall be considered an unsafe use of such drug under

15 paragraph (1). Safe levels may be established under

16 clause (i) either by regulation or order.

17 ‘‘(C) The Secretary may by general regulation

18 provide access to the records of veterinarians to as19 certain any use or intended use authorized under

20 subparagraph (A) that the Secretary has determined

21 may present a risk to the public health.

22 ‘‘(D) If the Secretary finds, after affording an

23 opportunity for public comment, that a use of an

24 animal drug authorized under subparagraph (A) pre25 sents a risk to the public health or that an analytical
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1 method required under subparagraph (B) has not

2 been developed and submitted to the Secretary, the

3 Secretary may, by order, prohibit any such use.

4 ‘‘(5) If the approval of an application filed

5 under section 505 is in effect, the drug under such

6 application shall not be deemed unsafe for purposes

7 of paragraph (1) and shall be exempt from the re8 quirements of section 502(f) with respect to a use or

9 intended use of the drug in animals if such use or

10 intended use—

11 ‘‘(A) is by or on the lawful written or oral

12 order of a licensed veterinarian within the con13 text of a veterinarian-client-patient relationship,

14 as defined by the Secretary; and

15 ‘‘(B) is in compliance with regulations pro16 mulgated by the Secretary that establish the

17 conditions for the use or intended use of the

18 drug in animals.’’.

19 (b) OTHER AMENDMENTS.—

20 (1) SECTION 301.—Section 301 of the Federal

21 Food, Drug, and Cosmetic Act (21 U.S.C. 331) is

22 amended—

23 (A) in paragraph (e), by inserting

24 ‘‘512(a)(4)(C),’’ before ‘‘512(j)’’,

25 (B) by adding at the end the following:
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1 ‘‘(u) The violation of section 512(a)(4)(A),

2 512(a)(4)(D), or 512(a)(5).’’.

3 (2) SECTION 512(e).—Section 512(e) of the

4 Federal Food, Drug, and Cosmetic Act (21 U.S.C.

5 360b(e) is amended in subparagraph (A), by insert6 ing before the semicolon the following: ‘‘or the condi7 tion of use authorized under subsection (a)(4)(A)’’.

8 (3) SECTION 512(l).—Section 512(l)(1) of the

9 Federal Food, Drug, and Cosmetic Act (21 U.S.C.

10 360b(l)(1)) is amended by inserting after ‘‘relating

11 to experience’’ the following: ‘‘, including experience

12 with uses authorized under subsection (a)(4)(A),’’.

13 (c) REGULATIONS.—Not later than 2 years after the

14 date of the enactment of this Act, the Secretary of Health

15 and Human Services shall promulgate regulations to im16 plement paragraphs (4)(A) and (5) of section 512(a) of

17 the Federal Food, Drug, and Cosmetic Act (as amended

18 by subsection (a)).

19 (d) EFFECTIVE DATE.—The amendments made by

20 this section shall take effect upon the adoption of final

21 regulations under subsection (c).

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