§ 6817. New drugs.
1.Except as otherwise provided in the Federal\nFood, Drug and Cosmetic Act, no person shall sell, deliver, offer for\nsale, hold for sale, or give away any new drug, unless:\n a. an application with respect thereto has become effective, or in the\ncase of an investigational drug the sponsor has complied with the\napplicable requirements, under the Federal Food, Drug, and Cosmetic Act,\nor\n b. when not subject to such act, such drug has been tested and has not\nbeen found to be unsafe or ineffective for use under the conditions\nprescribed, recommended or suggested in the labeling thereof, and, prior\nto selling or offering for sale such drug, there has been filed with the\ndepartment an application setting forth\n (1) full reports of investigations which have been
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§ 6817. New drugs. 1. Except as otherwise provided in the Federal\nFood, Drug and Cosmetic Act, no person shall sell, deliver, offer for\nsale, hold for sale, or give away any new drug, unless:\n a. an application with respect thereto has become effective, or in the\ncase of an investigational drug the sponsor has complied with the\napplicable requirements, under the Federal Food, Drug, and Cosmetic Act,\nor\n b. when not subject to such act, such drug has been tested and has not\nbeen found to be unsafe or ineffective for use under the conditions\nprescribed, recommended or suggested in the labeling thereof, and, prior\nto selling or offering for sale such drug, there has been filed with the\ndepartment an application setting forth\n (1) full reports of investigations which have been made to show\nwhether or not such drug is safe and effective for use;\n (2) a full list of the ingredients used as components of such drug;\n (3) a full statement of the composition of such drug;\n (4) a full description of the methods used in, and the facilities and\ncontrols used for, the manufacture, processing and packing of such\ndrugs;\n (5) such samples of such drug and of the ingredients used as\ncomponents thereof as the board or secretary may require; and\n (6) specimens of the labeling proposed to be used for such drug.\n 2. An application provided for in paragraph b of subdivision one shall\nbecome effective on the one hundred eightieth day after the filing\nthereof, except that if the secretary or board finds, after due notice\nto applicant and giving him an opportunity for a hearing, that the drug\nis not safe and effective for use under the conditions prescribed,\nrecommended, or suggested in the proposed labeling thereof, he shall,\nprior to the effective date of the application, issue an order refusing\nto permit the application to become effective.\n 3. A drug dispensed on a written or oral prescription of a physician,\ndentist, podiatrist or veterinarian (except a controlled substance),\nshall be exempt from the requirements of this section if such drug bears\na label containing the name and place of business of the dispenser, the\nserial number and date of the prescription, directions for use as may be\nstated in the prescription and the name of the physician, dentist,\npodiatrist or veterinarian issuing the prescription and the name of the\npatient. In addition, such drug shall bear a label containing the\nproprietary or brand name of the drug and, if applicable, the strength\nof the contents, unless the person issuing the prescription explicitly\nstates on the prescription, in his own handwriting, that the name of the\ndrug and the strength thereof should not appear on the label.\n 4. The board shall promulgate regulations for exempting from the\noperation of this section drugs (and with the concurrence of the\ncommissioner of health, pursuant to article thirty-three of the public\nhealth law, controlled substances) intended solely for investigational\nuse by experts qualified by scientific training and experience to\ninvestigate the safety and efficacy of drugs and labeled "For\nInvestigational Use Only". Such regulations may, within the discretion\nof the board, among other conditions relating to the protection of the\npublic health, provide for conditioning such exemptions upon:\n a. The submission to the secretary before any clinical testing of a\nnew drug is undertaken of reports by the manufacturer or sponsor of the\ninvestigation of such drug, of preclinical tests, including tests on\nanimals of such drug adequate to justify the proposed clincial testing.\n b. The manufacturer or the sponsor of the investigation of a new drug\nproposed to be distributed to investigators for clinical testing\nobtaining a signed agreement from each of such investigators that\npatients to whom the drug is administered will be under his personal\nsupervision, or under the supervision of investigators responsible to\nhim, and that he will not supply such drug to any other investigator or\nto clinics for administration to human beings; and\n c. The establishment and maintenance of such records and the making of\nsuch reports to the board by the manufacturer or the sponsor of the\ninvestigation of such drugs of data including, but not limited to,\nanalytical reports by investigators obtained as the result of such\ninvestigational use of such drug as the board finds will enable it to\nevaluate the safety and effectiveness of such drug in the event of the\nfiling of an application pursuant to subdivision one of this section.\n 5. This section shall not apply to any drug which was licensed under\nthe federal virus, serum, and toxin act of July first, nineteen hundred\ntwo (32 Stat. 728) or is licensed under section two hundred sixty-two of\nthe public health service act of July first, nineteen hundred forty-four\n(58 Stat. 682), or under the federal virus, serums, toxins, antitoxins\nand analogous products act of March fourth, nineteen hundred thirteen\n(37 Stat. 832).\n