§ 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 small packages.\n c. If any word, statement, or other information required by or under\nauthority of this article to appear on the label or labeling is not\nprominently placed thereon with such conspicuousness (as compared with\nother words, statements, designs, or devices, in the labeling) and in\nsuch terms as to render it likely to be read and understood by the\nordinary individual under customary conditions of purchase and use.\n d. If it is for use by man and contains any quantity of the narcotic\nor hypnotic substance alpha eucaine, barbituric acid, beta eucaine,\nbromal, cannabis, carbromal, chloral, coca, cocaine, codeine, heroin,\nmarihuana, morphine, opium, paraldehyde, peyote, or sulphonmethane; or\nany chemical derivative of such substance, which derivative has been by\nthe secretary, after investigation, found to be, and by regulations\nunder this article, or by regulations promulgated by the board,\ndesignated as, habit forming; unless its label bears the name and\nquantity, or proportion, of such substance or derivative and in\njuxtaposition therewith the statement "Warning--May be habit forming."\n e. If it is a drug and is not designated solely by a name recognized\nin an official compendium unless its label bears (1) the common or usual\nname of the drug, if such there be; and (2) in case it is fabricated\nfrom two or more ingredients, the common or usual name of each active\ningredient, including the kind and quantity by percentage or amount of\nany alcohol, and also including, whether active or not, the name and\nquantity or proportion of any bromides, ether, chloroform, acetanilid,\nacetphenetidin, amidopyrine, antipyrine, atropine, hyoscine,\nhyoscyamine, arsenic, digitalis, digitalis glucosides, mercury, ouabain,\nstrophanthin, strychnine, thyroid, or any derivative or preparation of\nany such substances, contained therein: Provided, that, to the extent\nthat compliance with the requirements of clause (2) of this paragraph is\nimpracticable, exemptions shall be established by regulations\npromulgated by the board.\n f. Unless its labeling bears (1) adequate directions for use; and (2)\nsuch adequate warnings against use in those pathological conditions or\nby children where its use may be dangerous to health, or against unsafe\ndosage or methods or duration of administration or application, in such\nmanner and form, as are necessary for the protection of users: Provided,\nthat, where any requirement of clause (1) of this paragraph, as applied\nto any drug or device, is not necessary for the protection of the public\nhealth, the board shall promulgate regulations exempting such drug or\ndevice from such requirement.\n g. If it purports to be a drug the name of which is recognized in an\nofficial compendium, unless it is packaged and labeled as prescribed\ntherein: Provided, that, the method of packing may be modified with the\nconsent of the secretary in accordance with regulations promulgated by\nthe board. Whenever a drug is recognized in both the United States\npharmacopoeia and the homeopathic pharmacopoeia of the United States, it\nshall be subject to the requirements of the United States pharmacopoeia\nwith respect to packaging and labeling unless it is labeled and offered\nfor sale as a homeopathic drug, in which case it shall be subject to the\nprovisions of the homeopathic pharmacopoeia of the United States, and\nnot to those of the United States pharmacopoeia.\n h. (1) If it is a drug and its container is so made, formed or filled\nas to be misleading; (2) if it is an imitation of another drug; (3) if\nit is offered for sale under the name of another drug; or (4) if it\nbears a copy, counterfeit, or colorable imitation of the trademark,\nlabel, container or identifying name or design of another drug.\n i. If it is dangerous to health when used in the dosage, or with the\nfrequency or duration prescribed, recommended or suggested in the\nlabeling thereof.\n j. Except as required by article thirty-three of the public health\nlaw, the labeling provisions of this article shall not apply to the\ncompounding and dispensing of drugs on the written prescription of a\nphysician, a dentist, a podiatrist or a veterinarian, which prescription\nwhen filled shall be kept on file for at least five years by the\npharmacist or druggist. Such drug shall bear a label containing the name\nand place of business of the dispenser, the serial number and date of\nthe prescription, directions for use as may be stated in the\nprescription, name and address of the patient and the name of the\nphysician or other practitioner authorized by law to issue the\nprescription. In addition, such label shall contain the proprietary or\nbrand name of the drug and, if applicable, the strength of the contents,\nunless the person issuing the prescription explicitly states on the\nprescription, in his own handwriting, that the name of the drug and the\nstrength thereof should not appear on the label.\n