Animal Medicinal Drug Use Clarification Act of 1994
PL 103-396 (S.340), enacted 10/22/1994

PUBLIC LAW 103-396—OCT. 22, 1994 
108 STAT. 4153 
Public Law 103-396 
103d Congress 
An Act 
To amend the Federal Food, Drug, and Cosmetic Act to clarify the application 
Q ^ 99 1994 
of the Act with respect to alternate uses of new animal drugs and new drugs 
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intended for human use, and for other purposes. 
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Be it enacted by the Senate and House of Representatives 
of 
the United States of America in Congress assembled. 
Animal 
Medicmal Drug 
SECTION 1. SHORT TITLE. 
V^e Clarification 
Act of 1994. 
This Act may be cited as the "Animal Medicinal Drug Use 21USC 301 note. 
Clarification Act 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 subsection (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 paragraph 
(1) and shall be exempt from the requirements 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 context of a veterinarian-client-patient 
relationship, as defined by the Secretary; and 
"(ii) is in compliance with regulations promulgated by the 
Secretary that establish the conditions for such different use 
or intended use. 
The regulations promulgated by the Secretary 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 
another animal drug that contains the same active ingredient and 
which is in the same dosage form and concentration provides for 
such different use. 
"(B) If the Secretary finds that there is a reasonable probability 
that a use of an animal drug authorized under subparagraph (A) 
may present a risk to the pubUc health, the Secretary may— 
"(i) establish a safe level for a residue of an animal drug 
when it is used for such different use authorized by subpara-
graph (A); and 
"(ii) require the development of a practical, analytical 
method for the detection of residues of such drug above the 
safe level estabUshed under clause (i). 
108 STAT. 4154 
PUBLIC LAW 103-396—(XTT. 22, 1994 
The use of an animal drug that 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 ascertain 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) presents a risk to the public health or that 
an analjrtical method required under subparagraph (B) has not 
been developed and submitted to the Secretary, the Secretary may, 
by order, prohibit £iny 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 requirements 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 context of a veterinarian-client-
patient relationship, as defined by the Secretary; and 
"(B) is in compliance with regulations promulgated 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 striking "507(d) or (g)," £ind 
inserting "507(d) or (g), 512(a)(4)(C),"; and 
(B) by adding at the end the following: 
"(u) The failure to comply with any requirements of the provi-
sions of, or any regulations or orders of the Secretary, under section 
512(a)(4)(A), 512(a)(4)(D), or 512(a)(5).". 
(2) SECTION 512(e).—Section 512(e)(1)(A) of the Federal 
Food, Drug and Cosmetic Act (21 U.S.C. 360b(e)(l)(A)) is 
amended by inserting before the semicolon the following: "or 
the condition of use authorized under subsection (a)(4)(A)". 
(3) SECTION 512(1).—Section 512(1)(1) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360b(l)(l)) is amended by 
striMng "relating to experience" and inserting "relating to 
experience, including experience with uses authorized under 
subsection (a)(4)(A),". 
21 use 360b 
(c) REGULATIONS.—Not later than 2 years after the date of 
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the enactment of this Act, the Secretary of Health and Human 
Services shall promulgate regulations to implement paragraphs 
(4)(A) and (5) of section 512(a) of the Federal Food, Drug, and 
Cosmetic Act (as amended by subsection (a)). 
21 use 360b 
(d) EFFECTIVE DATE.—The amendments made by this section 
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shall take effect upon the adoption of the final regulations under 
subsection (c). 
SEC. 3. MAPLE SYRUP. 
(a) PREEMPTION.—Section 403A(a) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 343-l(a)) is amended— 
(1) in paragraph (1), by inserting at the end the following: 
"except that this paragraph does not apply to a standard of 
PUBLIC LAW 103-396—OCT. 22, 1994 
108 STAT. 4155 
identity of a State or political subdivision of a State for maple 
syrup that is of the type required by sections 401 and 403(g),"; 
(2) in paragraph (2), by inserting at the end the following: 
"except that this paragraph does not apply to a requirement 
of a State or political subdivision of a State that is of the 
type required by section 403(c) and that is applicable to maple 
syrup,"; and 
(3) in paragraph (3) by inserting at the end the following: 
"except that this paragraph does not apply to a requirement 
of a State or political subdivision of a State that is of the 
type required by section 403(h)(1) and that is applicable to 
maple syrup,". 
(b) PROCEDURE.—Section 701(e)(1) (21 U.S.C. 371(e)(1)) is 
amended by striking "or maple syrup (regulated under section 
168.140 of title 21, Code of Federal Regulations).". 
Approved October 22, 1994. 
LEGISLATIVE HISTORY—S. 340: 
CONGRESSIONAL RECORD, Vol. 140 (1994): 
Oct. 4, considered and passed Senate. 
Oct. 6, considered and passed House.