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. BART-
LETT 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. COLE-
MAN, 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. HUTCH-
INSON, Mr. HUTTO, Mr. HYDE, Mr. INHOFE, Mr. JOHNSON of South Da-
kota, Mr. KLECZKA, Mr. KOLBE, Mr. KOPETSKI, Mr. KYL, Mr. LAN-
CASTER, 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. PACK-
ARD, 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. WIL-
SON, 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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(B) suffering or death would result from
failure to provide effective treatment; and
(4) duly licensed veterinarians possess the pro-
fessional training and medical judgment to admin-
ister drugs in a clinically appropriate manner that
benefits animals and safeguards the public health.
SEC. 3. PURPOSES.
The purposes of this Act are—
(1) to permit veterinarians to use such an ap-
proved animal drug, or approved drug intended for
human use, for therapeutic purposes in animals in
a manner that is not specified on the label of the
drug, if a valid veterinarian-client-patient relation-
ship exists; and
(2) to permit the Secretary of Health and
Human Services to establish conditions for such use
as may be necessary to protect the public health.
SEC. 4. ALTERNATE USES.
Section 512(a) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 360b(a)) is amended by adding at
the end the following new paragraphs:
‘‘(4)(A) Except as provided in subparagraph
(B), if an approval of an application filed under sub-
section (b) is in effect with respect to a particular
use or intended use of a new animal drug, the drug
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shall not be deemed unsafe for the purposes of sec-
tion 501(a)(5), and shall be exempt from the re-
quirements of section 502(f), with respect to a dif-
ferent use or intended use of the drug, if such use
or intended use—
‘‘(i) is by or on the lawful written or oral
order of a licensed veterinarian within the con-
text of a veterinarian-client-patient relationship,
as defined by the Secretary; and
‘‘(ii) is in compliance with regulations pro-
mulgated by the Secretary under subparagraph
(C).
‘‘(B) Notwithstanding subparagraph (A), if the
use of a new animal drug results in residues in food
that the Secretary has determined to be in violation
of established safe levels for such drug, such drug
shall then be deemed unsafe for the purposes of sec-
tion 501(a)(5), and shall be subject to the require-
ments of section 502(f).
‘‘(C) The Secretary shall implement final regu-
lations that establish the conditions for the use or
intended use of new animal drugs, as provided under
this paragraph and as may be necessary to protect
the public health, not later than one year after the
enactment of this Act.
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‘‘(5)(A) If an approval of an application filed
under section 505 is in effect with respect to a par-
ticular use or intended use of a drug intended for
human use, the drug shall not be deemed unsafe for
the purposes of section 501(a)(5), and shall be ex-
empt from the requirements of section 502(f), with
respect to a use or intended use of the drug in
nonfood producing animals, if such use or intended
use—
‘‘(i) is by or on the lawful written or oral
order of a licensed veterinarian within the con-
text of a veterinarian-client-patient relationship,
as defined by the Secretary; and
‘‘(ii) is in compliance with regulations pro-
mulgated by the Secretary under subparagraph
(B).
‘‘(B) The Secretary shall implement final regu-
lations that establish the conditions for the use or
intended use of human drugs, as provided under this
paragraph and as may be necessary to protect the
public health, not later than one year after the en-
actment of this Act.’’.
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