Section 18
SEC. 18. A drug or device shall be deemed to be adulterated:— (a) (1) If it consists in whole or in part of any filthy, putrid, decomposed substance; or (2) if it has been prepared, packed, or held under insanitary conditions contaminated with filth or whereby it may have been rendered injurious to health; or (3) if it is a drug and its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or (4) if it is a drug and it bears or contains, for purposes of coloring only, a coal-tar color other than a permissible one. (b) If it purports to be or is represented as a drug the name of which is recognized in an official compendium, and its strength differs from, or its quality or purity falls below, the standard set forth in such compendium, except that whenever 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 promulgate, upon recommendation of the Food and Drug Administrator, 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 standards is plainly stated on its label. (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 presented 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