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

103d CONGRESS
  1st Session
                                 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.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

             February 4 (legislative day, January 5), 1993

  Mr. Heflin (for himself, Mr. Pressler, Mr. Shelby, Mr. Daschle, Mr. 
  Conrad, Mr. Campbell, Mr. Brown, Mr. DeConcini, Mrs. Kassebaum, Mr. 
Danforth, Mr. Mack, Mr. Coats, Mr. Dorgan, Mr. Roth, Mr. Hollings, Mr. 
    Warner, Mr. Wofford, Mr. Feingold, Mr. Inouye, Mr. Chafee, Mr. 
 McConnell, Mr. Boren, Mr. Pryor, Mr. Kempthorne, Mr. Craig, Mr. Exon, 
    Mr. Reid, Mr. Nickles, Mr. Cochran, Mr. Johnston, Mr. Bond, Mr. 
 Grassley, and Mr. Dodd) introduced the following bill; which was read 
    twice and referred to the Committee on Labor and Human Resources

_______________________________________________________________________

                                 A BILL


 
   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. FINDINGS AND PURPOSES.

    (a) Findings.--Congress finds that--
            (1) the Federal Food, Drug, and Cosmetic Act currently 
        permits the use of an animal drug, or a drug intended for human 
        use, that is approved by the Food and Drug Administration, only 
        in accordance with the specific labeling approved for the drug;
            (2) there are not such approved animal drugs available to 
        relieve pain and suffering, or to treat every specific disease 
        or condition found, in each species of animal;
            (3) it is sometimes necessary for veterinarians to use such 
        an approved animal drug or approved drug intended for human use 
        in a manner that is not in accordance with the label of the 
        drug if--
                    (A) the health of an animal is immediately 
                threatened; and
                    (B) suffering or death would result from failure to 
                provide effective treatment; and
            (4) veterinarians possess the professional training and 
        medical judgment to administer drugs in a clinically-
        appropriate manner that benefits animals and safeguards the 
        public health.
    (b) Purposes.--The purposes of this Act are--
            (1) to permit veterinarians to use such an approved animal 
        drug, or approved drug intended for human use, for therapeutic 
        purposes in animals in a manner that is not specified on the 
        label of the drug, if a valid veterinarian-client-patient 
        relationship exists; and
            (2) to permit the Secretary of Health and Human Services to 
        establish conditions for such use as may be necessary to 
        protect the public health.

SEC. 2. ALTERNATE USES.

    Section 512(a) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360b(a)) is amended by adding at the end the following new 
paragraphs:
    ``(4) 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 
section 501(a)(5), and shall be exempt from the regulations of section 
502(f), with respect to a different use or intended use of the drug, 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; and
            ``(B) is in compliance with regulations promulgated by the 
        Secretary that establish such conditions for such use or 
        intended use as may be necessary to protect the public health.
    ``(5) If an approval of an application filed under section 505 is 
in effect with respect to a particular use or intended use of a drug 
intended for human use, the drug shall not be deemed unsafe for the 
purposes of section 501(a)(5), and shall be exempt from the 
requirements of section 502(f), with respect to a use or intended use 
of the drug in non-food producing animals, if such use or intended use 
complies with the requirements specified in subparagraph (A) or (B) of 
paragraph (4).''.

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