Section 6817. New drugs

1. 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).