[Congressional Bills 103th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1423 Introduced in House (IH)]

103d CONGRESS
  1st Session
                                H. R. 1423

  To amend the Federal Food, Drug, and Cosmetic Act to allow licensed 
veterinarians to order the extra-label use of drugs in animals, and for 
                            other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             March 18, 1993

Mr. Stenholm (for himself, Mr. Allard, Mr. Andrews of Maine, Mr. Armey, 
   Mr. Baker of Louisiana, Mr. Barrett of Nebraska, Mr. Bartlett of 
  Maryland, Mr. Bereuter, Mr. Boehlert, Mr. Boehner, Mr. Bonilla, Mr. 
Brewster, Mr. Browder, Mr. Brown of California, Mr. Bryant, Mr. Burton 
   of Indiana, Mr. Camp, Mr. Chapman, Mr. Coleman, Mr. Combest, Mr. 
 Condit, Mr. Costello, Mr. Cramer, Mr. Dooley, Mr. Dornan, Mr. Duncan, 
       Mr. Emerson, Mr. Ewing, Mr. Fields of Texas, Mr. Frank of 
Massachusetts, Mr. Frost, Mr. Gallegly, Mr. Gibbons, Mr. Glickman, Mr. 
 Goodling, Mr. Gordon, Mr. Gunderson, Mr. Hall of Texas, Mr. Hamilton, 
 Mr. Hancock, Mr. Hansen, Mr. Hastert, Mr. Hastings,  Mr. Hefner, Mr. 
   Hutchinson, Mr. Hutto, Mr. Hyde, Mr. Inhofe, Mr. Johnson of South 
 Dakota, Mr. Kleczka, Mr. Kolbe, Mr. Kopetski, Mr. Kyl, Mr. Lancaster, 
    Mr. Lehman, Mr. Lewis of Florida, Mr. Lightfoot, Ms. Long, Mr. 
McCloskey, Mr. McCrery, Mr. Montgomery, Mr. Neal of North Carolina, Mr. 
Nussle, Mr. Oberstar, Mr. Oxley, Mr. Packard, Mr. Paxon, Mr. Penny, Mr. 
Pickett, Mr. Pomeroy, Mr. Roth, Mr. Rowland, Mr. Royce, Mr. Sarpalius, 
  Mr. Sensenbrenner, Mr. Shaw, Mr. Shays, Ms. Slaughter, Mr. Smith of 
Michigan, Ms. Snowe, Mr. Stump, Mr. Swift, Mr. Tanner, Mr. Torres, Mr. 
Towns, Mrs. Unsoeld, Mr. Upton, Mrs. Vucanovich, Mr. Walsh, Mr. Wilson, 
    Mr. Young of Alaska, Mr. Zeliff, and Mr. Zimmer) introduced the 
   following bill; which was referred to the Committee on Energy and 
                                Commerce

_______________________________________________________________________

                                 A BILL


 


    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 1993''.

SEC. 2. 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) duly licensed veterinarians possess the professional 
        training and medical judgment to administer drugs in a 
        clinically appropriate manner that benefits animals and 
        safeguards the public health.

SEC. 3. 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. 4. 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)(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 section 501(a)(5), and shall be exempt from the 
        requirements of section 502(f), with respect to a different use 
        or intended use of the drug, 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 under subparagraph (C).
            ``(B) Notwithstanding subparagraph (A), if the use of a new 
        animal drug results in residues in food that the Secretary has 
        determined to be in violation of established safe levels for 
        such drug, such drug shall then be deemed unsafe for the 
        purposes of section 501(a)(5), and shall be subject to the 
        requirements of section 502(f).
            ``(C) The Secretary shall implement final regulations that 
        establish the conditions for the use or intended use of new 
        animal drugs, as provided under this paragraph and as may be 
        necessary to protect the public health, not later than one year 
        after the enactment of this Act.
            ``(5)(A) 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 nonfood 
        producing animals, 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 under subparagraph (B).
            ``(B) The Secretary shall implement final regulations that 
        establish the conditions for the use or intended use of human 
        drugs, as provided under this paragraph and as may be necessary 
        to protect the public health, not later than one year after the 
        enactment of this Act.''.

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