Page:United States Statutes at Large Volume 102 Part 4.djvu/1013

 PUBLIC LAW 100-670—NOV. 16, 1988

102 STAT. 3983

request that any data or information received under such paragraph shall not be disclosed by such person to any other person— "(A) for the purpose of, or as part of a plan, scheme, or device for, obtaining the right to make, use, or market, or making, using, or marketing, outside the United States, the drug identified in the application filed under subsection (b)(l), and "(B) without obtaining from any person to whom the data and information are disclosed an identical verified statement, a copy of which is to be provided by such person to the Secretary, which meets the requirements of this paragraph.". 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)(l)(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 o r ^ n a l 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 Fraud. 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), (i)(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.

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