NY Educ L § 6817 (2021)
2021 New York Laws EDN - Education Title 8 - The Professions Article 137 - Pharmacy 6817 - New Drugs.

§ 6817. New  drugs.  1.  Except  as  otherwise provided in the Federal Food, Drug and Cosmetic Act, no person shall sell,  deliver,  offer  for sale, hold for sale, or give away any new drug, unless:   a. an application with respect thereto has become effective, or in the case  of  an  investigational  drug  the  sponsor  has complied with the applicable requirements, under the Federal Food, Drug, and Cosmetic Act, or   b. when not subject to such act, such drug has been tested and has not been found to be unsafe or ineffective  for  use  under  the  conditions prescribed, recommended or suggested in the labeling thereof, and, prior to selling or offering for sale such drug, there has been filed with the department an application setting forth  (1)  full  reports  of  investigations  which  have  been made to show whether or not such drug is safe and effective for use;  (2) a full list of the ingredients used as components of such drug;  (3) a full statement of the composition of such drug;  (4) a full description of the methods used in, and the facilities  and controls  used  for,  the  manufacture,  processing  and packing of such drugs;  (5) such  samples  of  such  drug  and  of  the  ingredients  used  as components thereof as the board or secretary may require; and  (6) specimens of the labeling proposed to be used for such drug.   2. An application provided for in paragraph b of subdivision one shall become  effective  on  the  one  hundred  eightieth day after the filing thereof, except that if the secretary or board finds, after  due  notice to  applicant and giving him an opportunity for a hearing, that the drug is not safe and effective  for  use  under  the  conditions  prescribed, recommended,  or  suggested  in the proposed labeling thereof, he shall, prior to the effective date of the application, issue an order  refusing to permit the application to become effective.   3.  A drug dispensed on a written or oral prescription of a physician, dentist, podiatrist or veterinarian  (except  a  controlled  substance), shall be exempt from the requirements of this section if such drug bears a  label containing the name and place of business of the dispenser, the serial number and date of the prescription, directions for use as may be stated in the prescription and  the  name  of  the  physician,  dentist, podiatrist  or veterinarian issuing the prescription and the name of the patient. In addition, such  drug  shall  bear  a  label  containing  the proprietary  or  brand name of the drug and, if applicable, the strength of the contents, unless the person issuing the  prescription  explicitly states on the prescription, in his own handwriting, that the name of the drug and the strength thereof should not appear on the label.   4.  The  board  shall  promulgate  regulations  for exempting from the operation of this  section  drugs  (and  with  the  concurrence  of  the commissioner  of  health, pursuant to article thirty-three of the public health law, controlled substances) intended solely  for  investigational use  by  experts  qualified  by  scientific  training  and experience to investigate  the  safety  and  efficacy  of  drugs  and   labeled   "For Investigational  Use  Only". Such regulations may, within the discretion of the board, among other conditions relating to the protection  of  the public health, provide for conditioning such exemptions upon:   a.  The  submission  to the secretary before any clinical testing of a new drug is undertaken of reports by the manufacturer or sponsor of  the investigation  of  such  drug,  of preclinical tests, including tests on animals of such drug adequate to justify the proposed clincial testing.   b. The manufacturer or the sponsor of the investigation of a new  drug proposed  to  be  distributed  to  investigators  for  clinical  testing obtaining a signed  agreement  from  each  of  such  investigators  that  patients  to  whom  the  drug is administered will be under his personal supervision, or under the supervision of  investigators  responsible  to him,  and that he will not supply such drug to any other investigator or to clinics for administration to human beings; and   c. The establishment and maintenance of such records and the making of such  reports  to  the  board  by the manufacturer or the sponsor of the investigation of such drugs of  data  including,  but  not  limited  to, analytical  reports  by  investigators  obtained  as  the result of such investigational use of such drug as the board finds will  enable  it  to evaluate  the  safety and effectiveness of such drug in the event of the filing of an application pursuant to subdivision one of this section.   5. This section shall not apply to any drug which was  licensed  under the  federal virus, serum, and toxin act of July first, nineteen hundred two (32 Stat. 728) or is licensed under section two hundred sixty-two of the public health service act of July first, nineteen hundred forty-four (58 Stat. 682), or under the federal virus, serums,  toxins,  antitoxins and  analogous  products  act of March fourth, nineteen hundred thirteen (37 Stat. 832).