[Congressional Bills 103th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5056 Introduced in House (IH)]

103d CONGRESS
  2d Session
                                H. R. 5056

  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

                           September 19, 1994

Mr. Stenholm (for himself, Mr. Waxman, and Mr. Dingell) introduced the 
   following bill; which was referred to the Committee on Energy and 
                                Commerce

_______________________________________________________________________

                                 A BILL


 
  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.

    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 Drug Amendments 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.
        Regulations 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 which 
        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 the 
                drug above the safe level established under clause (i).
        The use of an animal drug which 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 inserting 
                ``512(a)(4)(C),'' before ``512(j)'',
                    (B) by adding at the end the following:
            ``(u) The violation of section 512(a)(4)(A), 512(a)(4)(D), 
        or 512(a)(5).''.
            (2) Section 512(e).--Section 512(e) of the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 360b(e) is amended in 
        subparagraph (A), 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 
        inserting after ``relating to experience'' the following: ``, 
        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 final regulations under subsection (c).
                                 <all>