FILE s340.enr
          --S.340--
              S.340
          One Hundred Third Congress
          of the
          United States of America
          AT THE SECOND SESSION
          Begun and held at the City of Washington on Tuesday,
          the twenty-fifth day of January, one thousand nine hundred and
          ninety-four
          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).'.
          Speaker of the House of Representatives.
          Vice President of the United States and  
          President of the Senate.