2023 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).