[Congressional Bills 103th Congress]
[From the U.S. Government Publishing Office]
[S. 340 Engrossed in Senate (ES)]

103d CONGRESS

  2d Session

                                 S. 340

_______________________________________________________________________

                                 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.
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
103d CONGRESS
  2d Session
                                 S. 340

_______________________________________________________________________

                                 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).''.

            Passed the Senate October 4 (legislative day, September 
      12), 1994.

            Attest:






                                                             Secretary.