Page:United States Statutes at Large Volume 52.djvu/1091

 PUBLIC LAWS-CH. 675-JUNE 25, 1938 assay set forth in such compendium, except that whenever tests or methods of assay have not been prescribed in such compendium, or such tests or methods of assay as are prescribed are, in the judgment of the Secretary, insufficient for the making of such determination, the Secretary shall bring such fact to the attention of the appropriate body charged with the revision of such compendium, and if such body fails within a reasonable time to prescribe tests or methods of assay which, in the judgment of the Secretary, are sufficient for purposes of this paragraph, then the Secretary shall promulgate regulations prescribing appropriate tests or methods of assay in accordance with which such determination as to strength, quality, or purity shall be made. No drug defined in an official compendium shall be deemed to be adulterated under this paragraph because it differs from the standard of strength, quality, or purity therefor set forth in such compendium, if its difference in strength, quality, or purity from such standard is plainly stated on its label. Whenever a drug is recognized in both the United States Pharmacopoeia and the Homceopathic Pharmacopceia of the United States it shall be subject to the requirements of the United States Pharmacopoeia unless it is labeled and offered for sale as a homceopathic drug, in which case it shall be subject to the provisions of the Homceopathic Pharma- copceia of the United States and not to those of the United States Pharmacopoeia. (c) If it is not subject to the provisions of paragraph (b) of this section and its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess. (d) If it is a drug and any substance has been (1) mixed or packed therewith so as to reduce its quality or strength or (2) substituted wholly or in part therefor. MISBRANDED DRUGS AND DEVICES Misbranded drugs and devices. SEC. 502. A drug or device shall be deemed to be misbranded- False, etc., labeling. (a) If its labeling is false or misleading in any particular. Labels, information (b) If in package form unless it bears a label containing (1) the name and place of business of the manufacturer, packer, or distribu- tor; and (2) an accurate statement of the quantity of the contents Variations and ex. in terms of weight, measure, or numerical count: Provided, That emptions. under clause (2) of this paragraph reasonable variations shall be per- mitted, and exemptions as to small packages shall be established, by regulations prescribed by the Secretary. ProminenceofInfor- 7. mation required by (c) If any word, statement, or other information required by or Act. under authority of this Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use. bDrugs wchgmay (d) If it is for use by man and contains any quantity of the nar- cotic or hypnotic substance alpha eucaine, barbituric acid, beta- eucaine, bromal, cannabis, carbromal, chloral, coca, cocaine, codeine, heroin, marihuana, morphine, opium, paraldehyde, peyote, or sul- phonmethane; or any chemical derivative of such substance, which derivative has been by the Secretary, after investigation, found to be, and by regulations designated as, habit forming; unless its label bears the name, quantity, and percentage of such substance or derivative and in juxtaposition therewith the statement "Warning-May be habit forming". sDotldeby eSged (e) If it is a drug and is not designated solely by a name recog- nam e- nized in an official compendium unless its label bears (1) the common 1050 [52 STAT.

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