Page:United States Statutes at Large Volume 76.djvu/839

 76 STAT.]

791

PUBLIC LAW 87-781-OCT. 10, 1962

Pharmacopeia and in the Homoeopathic Pharmacopoeia under different official titles, the official title used in the United States Pharmacopeia shall apply unless it is labeled and offered for sale as a homoeopathic drug, in which case the official title used in the Homoeopathic Pharmacopoeia shall apply." (b) Section 502(g) of such Act (21 U.S.C. 352(g)) is amended by inserting immediately before the period at the end thereof a colon and the following proviso: '''•Provided further, That, in the event of inconsistency between the requirements of this paragraph and those of paragraph (e) as to the name by which the drug or its ingredients shall be designated, the requirements of paragraph (e) shall prevail". (c) This section shall take effect on the first day of the seventh calendar month following the month in which this Act is enacted.

52 Stat. 1050.

EXCLUSION OF COSMETICS

SEC. 113. Chapter V of the Federal Food, Drug, and Cosmetic Act, as amended by section 111 of this Act, is further amended by adding at the end thereof the following: ((NONAPPLICABILITY

Ante,

p. 789.

TO COSMETICS

"SEC. 509. This chapter, as amended by the Drug Amendments of 1962, shall not apply to any cosmetic unless such cosmetic is also a drug or device or component thereof." INFORMATION TO P H Y S I C I A N S

SEC. 114. (a) Section 301 of the Federal Food, Drug, and Cosnietic Act (21 U.S.C. 331), as amended by this Act, is further amended by adding at the end thereof the following new paragraph: " (o) I n the case of a prescription drug distributed or offered for sale in interstate commerce, the failure of the manufacturer, packer, or distributor thereof to maintain for transmittal, or to transmit, to any practitioner licensed by applicable State law to administer such drug who makes written request for information as to such drug, true and correct copies of all printed matter which is required to be included in any package in which that drug is distributed or sold, or such other printed matter as is approved by the Secretary. Nothing in this paragraph shall be construed to exempt any person from any labeling requirement imposed by or under other provisions of this Act." (b) This section shall take effect on the first day of the seventh calendar month following the month in which this Act is enacted.

52 Stat. 1042.

PART C — AMENDMENTS AS TO ADVERTISING PRESCRIPTION DRUG ADVERTISEMENTS

SEC. 131. (a) Section 502 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352) is further amended by adding at the end thereof the following new paragraph: " (n) I n the case of any prescription drug distributed or offered for sale in any State, unless the manufacturer, packer, or distributor thereof includes in all advertisements and other descriptive printed matter issued or caused to be issued by the manufacturer, packer, or distributor with respect to that drug a true statement of (1) the established name as defined in section 502(e), printed prominently and in type at least half as large as that used for any trade or brand name thereof, (2) the formula showing quantitatively each ingredient of such drug to the extent required for labels under section 502(e), and (3) such other information in brief summary relating to side effects.

52 Stat. 1050.

Ante, p. 790.

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