65
STAT.]
649
PUBLIC LAW 215—OCT. 26, 1961
shall be dispensed only (i) upon a written prescription of a practitioner licensed by law to administer such drug, or (ii) upon an oral prescription of such practitioner which is reduced promptly to writing and filed b ^ the pharmacist, or (iii) by refilling any such written or oral prescription if such refilling is authorized by the prescriber either in the original prescription or by oral order which is reduced promptly to writing and filed by the pharmacist. 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 dispensed by filling or refilling a written or oral prescription of a practitioner licensed by law to administer such drug shall be exempt from the requirements of section 502, except paragraphs (a), (i)(2) and (3), (k), and (1), and the packaging requirements of paragraphs (g) and (h), if the drug bears a label containing the name and address of the dispenser, the serial number and date of the prescription or of its filling, the name of the prescriber, and, if stated in the prescription, the name of the patient, and the directions for use and cautionary statements, if any, contained in such prescription. This exemption shall not apply to any drug dispensed in the course of the conduct of a business of dispensing drugs pursuant to diagnosis by mail, or to a drug dispensed in violation of paragraph (1) of this subsection. " (3) The Administrator may by regulation remove drugs subject to section 502(d) and section 505 from the requirements of paragraph (1) of this subsection when such requirements are not necessary for the protection of the public health. "(4) A drug which is subject to paragraph (1) of this subsection shall be deemed to be misbranded if at any time prior to dispensing its label fails to bear the statement 'Caution: Federal law prohibits dispensing without prescription'. A drug to which paragraph (1) of this subsection does not apply shall be deemed to be misbranded if at any time prior to dispensing its label bears the caution statement quoted in the preceding sentence. "(5) Nothing in this subsection shall be construed to relieve any person from any requirement prescribed by or under authority of law with respect to drugs now included or which may hereafter be included within the classifications stated in section 3220 of the Internal Revenue Code (26 U.S.C. 3220), or to marihuana as defined in section 3238 (b) of the Internal Revenue Code (26 U.S.C. 3238 (b)). " SEC. 2. Subsection (c) of section 303 of the Federal Food, Drug, and Cosmetic Act, as amended, is amended by striking out the period at the end of clause (3) and inserting in lieu thereof a semicolon and the folio wing: "or (4) for having violated section 301(b), (c) or (k) by failure to comply with section 502(f) in respect to an article received in interstate commerce to which neither section 503(a) nor section 503 (b)(1) is applicable, if the delivery or proffered delivery was made in good faith and the labeling at the time thereof contained the same directions for use and warning statements as were contained in the labeling at the time of such receipt of such article." SEC. 3. The provisions of this Act shall take effect six months after the date of its enactment. Approved October 26, 1951.
Exemption from certain labeling requirements. 2 1 U. 8. C. j362.
E x e m p t i o n from prescription requirements. 21 U.S.C. }} 352,, 355. Drugs deemed to be misbranded.
Compliance with, n a r c o t i c s or marihuana laws.
53 Stat. 382. 53 Stat. 387.
21 U. 8. C. { 333.
Effective date.
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