21 USC 360b (A) ANIMAL MEDICINAL DRUG USE CLARIFICATION ACT OF 1994

--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.