A drug or device shall be deemed to be adulterated:
(a)(1) If it consists in whole or in part of any filthy, putrid, or decomposed substance; or (2)(A) if it has been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health or (B) if it is a drug and the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirements of the Federal Food, Drug, and Cosmetic Act, as amended, as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purports or is
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A drug or device shall be deemed to be adulterated: (a)(1) If it consists in whole or in part of any filthy, putrid, or decomposed substance; or (2)(A) if it has been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health or (B) if it is a drug and the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirements of the Federal Food, Drug, and Cosmetic Act, as amended, as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purports or is represented to possess; 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 (A) it is a drug which bears or contains, for purposes of coloring only, a color additive which is unsafe within the meaning of Section 706(a) of the Federal Food, Drug, and Cosmetic Act, as amended, (B) it is a color additive the intended use of which in or on drugs is for purposes of coloring only and is unsafe within the meaning of Section 706(a) of the Federal Food, Drug, and Cosmetic Act, as amended; or (5) if it is a new animal drug which is unsafe within the meaning of Section 512 of the Federal Food, Drug, and Cosmetic Act, as amended; or (6) if it is an animal feed bearing or containing a new animal drug, and such animal feed is unsafe within the meaning of Section 512 of the Federal Food, Drug, and Cosmetic Act, as amended. (b) If it purports 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. Such determination as to strength, quality, or purity shall be made in accordance with the tests or methods of assay set forth in such compendium, except that whenever tests or methods of assay have not been prescribed in such compendium, or those prescribed under authority of the Federal act, or such tests or methods of assay as are prescribed are, in the judgment of the Director of Health and Environmental Control, insufficient for the making of such determination, the Director 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 Director, are sufficient for purposes of this paragraph, then the Director 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, purity therefor set forth in such compendium, if its difference in strength, quality, or purity from such standards is plainly stated on its label. Whenever a drug is recognized in both the United States Pharmacopoeia and the Homeopathic Pharmacopoeia 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 homeopathic drug in which case it shall be subject to the provisions of the Homeopathic Pharmacopoeia 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 of strength or (2) substituted wholly or in part therefor.