§ 6815. Adulterating, misbranding and substituting. 1. Adultered\ndrugs. A drug or device shall be deemed to be adulterated:\n a. (1) If it consists in whole or in part of any filthy, putrid, or\ndecomposed substance; or (2) if it has been prepared, packed, or held\nunder insanitary conditions whereby it may have been contaminated with\nfilth, or whereby it may have been rendered injurious to health; or (3)\nif it is a drug and its container is composed, in whole or in part, of\nany poisonous or deleterious substance which may render the contents\ninjurious to health; or (4) if it is a drug and it bears or contains,\nfor purposes of coloring only, a coal-tar color other than one from a\nbatch that has been certified in accordance with regulations provided in\nthis article.\n b. If it purports to be, or is represented as, a drug the name of\nwhich is recognized in an official compendium, and its strength differs\nfrom, or its quality or purity falls below, the standard set forth in\nsuch compendium. Such determination as to strength, quality or purity\nshall be made in accordance with the tests or methods of assay set forth\nin such compendium, or, in the absence or inadequacy of such tests or\nmethods of assay, then in accordance with tests or methods of assay\nprescribed by regulations of the board of pharmacy as promulgated under\nthis article. Deviations from the official assays may be made in the\nquantities of samples and reagents employed, provided they are in\nproportion to the quantities stated in the official compendium. No drug\ndefined in an official compendium shall be deemed to be adulterated\nunder this paragraph because (1) it exceeds the standard of strength\ntherefor set forth in such compendium, if such difference is plainly\nstated on its label; or (2) it falls below the standard of strength,\nquality, or purity therefor set forth in such compendium if such\ndifference is plainly stated on its label, except that this clause shall\napply only to such drugs, or classes of drugs, as are specified in regu-\nlations which the board shall promulgate when, as applied to any drug,\nor class of drugs, the prohibition of such difference is not necessary\nfor the protection of the public health. Whenever a drug is recognized\nin both the United States pharmacopoeia and the homeopathic\npharmacopoeia of the United States, it shall be subject to the\nrequirements of the United States pharmacopoeia unless it is labeled and\noffered for sale as a homeopathic drug, in which case it shall be\nsubject to the provisions of the homeopathic pharmacopoeia of the United\nStates and not to those of the United States pharmacopoeia.\n c. If it is not subject to the provisions of paragraph b of this\nsubdivision and its strength differs from, or its purity or quality\nfalls below, that which it purports or is represented to possess.\n d. If it is a drug and any substance has been (1) mixed or packed\ntherewith so as to reduce its quality or strength or (2) substituted\nwholly or in part therefor.\n e. If it is sold under or by a name not recognized in or according to\na formula not given in the United States pharmacopoeia or the national\nformulary but that is found in some other standard work on pharmacology\nrecognized by the board, and it differs in strength, quality or purity\nfrom the strength, quality or purity required, or the formula prescribed\nin, the standard work.\n 2. Misbranded and substituted drugs and devices. A drug or device\nshall be deemed to be misbranded:\n a. If its labeling is false or misleading in any particular.\n b. If in package form, unless it bears a label containing (1) the name\nand place of business of the manufacturer, packer, or distributor; and\n(2) an accurate statement of the quantity of the contents in terms of\nweight, measure, or numerical count: Provided, that under clause (2) of\nthis paragraph the board may establish reasonable variations as to\nquantity and exemptions as to sma
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