[Congressional Record Volume 140, Number 142 (Tuesday, October 4, 1994)]
[Senate]
[Page S]
From the Congressional Record Online through the Government Printing Office [www.gpo.gov]


[Congressional Record: October 4, 1994]
From the Congressional Record Online via GPO Access [wais.access.gpo.gov]

 
                          AMENDMENTS SUBMITTED

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            FEDERAL FOOD, DRUG, AND COSMETIC ACT AMENDMENTS

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                       HEFLIN AMENDMENT NO. 2612

  Mr. FORD (for Mr. Heflin) proposed an amendment to the bill (S. 340) 
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; as 
follows:

       Strike all after the enacting clause, and insert in lieu 
     there the following:

     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).''.

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