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.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ‘‘Animal Drug Amend-
ments of 1994’’.
SEC. 2. UNAPPROVED USES
(a) GENERAL RULE.—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) 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
shall not be deemed unsafe for the purposes of para-
graph (1) and shall be exempt from the require-
ments of section 502(f) with respect to a different
use or intended use of the drug, other than a use
in or on animal feed, 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 that establish the
conditions for such different use or intended
use.
Regulations under clause (ii) may prohibit particular
uses of an animal drug and shall not permit such
different use of an animal drug if the labeling of an-
other animal drug which contains the same active in-
gredient and which is in the same dosage form and
concentration provides for such different use.
‘‘(B) If the Secretary finds that there is a rea-
sonable probability that a use of an animal drug au-
thorized under subparagraph (A) may present a risk
to the public health, the Secretary may—
‘‘(i) establish a safe level for a residue of
an animal drug when it is used for such dif-
ferent use authorized by subparagraph (A); and
‘‘(ii) require the development of a prac-
tical, analytical method for the detection of resi-
dues of the drug above the safe level established
under clause (i).
The use of an animal drug which results in residues
exceeding a safe level established under clause (i)
shall be considered an unsafe use of such drug under
paragraph (1). Safe levels may be established under
clause (i) either by regulation or order.
‘‘(C) The Secretary may by general regulation
provide access to the records of veterinarians to as-
certain any use or intended use authorized under
subparagraph (A) that the Secretary has determined
may present a risk to the public health.
‘‘(D) If the Secretary finds, after affording an
opportunity for public comment, that a use of an
animal drug authorized under subparagraph (A) pre-
sents a risk to the public health or that an analytical
method required under subparagraph (B) has not
been developed and submitted to the Secretary, the
Secretary may, by order, prohibit any such use.
‘‘(5) If the approval of an application filed
under section 505 is in effect, the drug under such
application shall not be deemed unsafe for purposes
of paragraph (1) and shall be exempt from the re-
quirements of section 502(f) with respect to a use or
intended use of the drug in animals if such use or
intended use—
‘‘(A) 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
‘‘(B) is in compliance with regulations pro-
mulgated by the Secretary that establish the
conditions for the use or intended use of the
drug in animals.’’.
(b) OTHER AMENDMENTS.—
(1) SECTION 301.—Section 301 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 331) is
amended—
(A) 
in 
paragraph 
(e), 
by 
inserting
‘‘512(a)(4)(C),’’ before ‘‘512(j)’’,
(B) by adding at the end the following:
‘‘(u) The violation of section 512(a)(4)(A),
512(a)(4)(D), or 512(a)(5).’’.
(2) SECTION
512(e).—Section 512(e) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360b(e) is amended in subparagraph (A), by insert-
ing before the semicolon the following: ‘‘or the condi-
tion of use authorized under subsection (a)(4)(A)’’.
(3) SECTION 512(l).—Section 512(l)(1) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360b(l)(1)) is amended by inserting after ‘‘relating
to experience’’ the following: ‘‘, including experience
with uses authorized under subsection (a)(4)(A),’’.
(c) REGULATIONS.—Not later than 2 years after the
date of the enactment of this Act, the Secretary of Health
and Human Services shall promulgate regulations to im-
plement paragraphs (4)(A) and (5) of section 512(a) of
the Federal Food, Drug, and Cosmetic Act (as amended
by subsection (a)).
(d) EFFECTIVE DATE.—The amendments made by
this section shall take effect upon the adoption of final
regulations under subsection (c).
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