FILE s340.enr
--S.340--
S.340
One Hundred Third Congress
of the
United States of America
AT THE SECOND SESSION
Begun and held at the City of Washington on Tuesday,
the twenty-fifth day of January, one thousand nine hundred and
ninety-four
An Act
To amend the Federal Food, Drug, and Cosmetic Act to clarify the
application of the Act with respect to alternate uses of new animal
drugs and new drugs intended for human use, and for other purposes.
Be it enacted by the Senate and House of
Representatives of the United States of America in Congress
assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the `Animal Medicinal Drug Use
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 public 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
subparagraph (A); and
`(ii) require the development of a practical, analytical
method for the detection of residues of such drug above the
safe level established under clause (i).
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
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
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),' and
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
provisions 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)(1)(A)) is amended by
inserting before the semicolon the following: `or the condition
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
striking `relating to experience' and inserting `relating to
experience, 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 implement 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 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. 343-1(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
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).'.
Speaker of the House of Representatives.
Vice President of the United States and
President of the Senate.