VETERINARY PRESCRIPTION DRUGS.

SEC. 105. VETERINARY PRESCRIPTION DRUGS. Section 503 (21 U.S.C. 353) is amended by adding at the end thereof the following new subsection: “(c)(1)(A) A drug intended for use by animals other than man which— “(i) because of its toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary for its use, is not safe for animal use except under the professional supervision of a licensed veterinarian, or “(ii) is limited by an approved application under subsection (b) of section 512 to use under the professional supervision of a licensed veterinarian, shall be dispensed only by or upon the lawful written or oral order of a licensed veterinarian in the course of the veterinarian’s professional practice. “(B) For purposes of subparagraph (A), an order Is lawful if the order— “(i) is a prescription or other order authorized by law, “(ii) is, if an oral order, promptly reduced to writing by the person lawfully filling the order, and filed by that person, and “(iii) is refilled only if authorized in the original order or in a subsequent oral order promptly reduced to writing by the person lawfully filling the order, and filed by that person. “(C) The act of dispensing a drug contrary to the provisions of this paragraph shall be deemed to be an act which results in the drug being misbranded while held for sale. “(2) Any drug when dispensed in accordance with paragraph (1) of this subsection— “(A) shall be exempt from the requirements of section 502, except subsections (a), (g), (h), (1)(2), (i)(3), and (p) of such section, and “(B) shall be exempt from the packaging requirements of subsections (g), (h), and (p) of such section, if— “(i) when dispensed by a licensed veterinarian, the drug bears a label containing the name and address of the practitioner and any directions for use and cautionary statements specified by the practitioner, or “(ii) when dispensed by filling the lawful order of a licensed veterinarian, the drug bears a label containing the name and address of the dispenser, the serial number and date of the order or of its filling, the name of the licensed veterinarian, and the directions for use and cautionary statements, if any, contained in such order. The preceding sentence shall not apply to any drug dispensed in the course of the conduct of a business of dispensing drugs pursuant to diagnosis by mail. 102 STAT. 3984 “(3) The Secretary may by regulation exempt drugs for animals other than man subject to section 512 from the requirements of paragraph (1) when such requirements are not necessary for the protection of the public health. “(4) A drug which is subject to paragraph (1) shall be deemed to be misbranded if at any time prior to dispensing its label fails to bear the statement ‘Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.’. A drug to which paragraph (1) does not apply shall be deemed to be misbranded if at any time prior to dispensing its label bears the statement specified m the preceding sentence.”.