PUBLIC LAW 103-396—OCT. 22, 1994 108 STAT. 4153 Public Law 103-396 103d Congress An Act To amend the Federal Food, Drug, and Cosmetic Act to clarify the application Q^ 99 1994 of the Act with respect to alternate uses of new animal drugs and new drugs ' intended for human use, and for other purposes. "^ o- «4UJ Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled. Animal Medicmal Drug SECTION 1. SHORT TITLE. V^e Clarification Act of 1994. This Act may be cited as the "Animal Medicinal Drug Use 21 USC 301 note. 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).
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