2018 New York Laws
PBH - Public Health
Article 33 - Controlled Substances
Title 3 - Research, Instructional Activities, and Chemical Analysis Relating to Controlled Substances
3325 - Authority to Issue Licenses; Applications.

§  3325. Authority to issue licenses; applications.  1. Subject to the
  provisions of this title, the commissioner is authorized  to  license  a
  person  to  manufacture,  obtain  and  possess, dispense, and administer
  controlled substances for  purposes  of  scientific  research,  chemical
  analysis or instruction.
2.  A  license  or  amendment  of  a  license  shall  be issued by the
  department unless  the  applicant  therefor  has  failed  to  furnish  a
  satisfactory  protocol pursuant to subdivision three of this section, or
  a satisfactory statement pursuant to section 3326, and  proof  that  the
  applicant:
(a) and its managing officers are of good moral character;
(b)  possesses  or  is  capable  of  acquiring  facilities,  staff and
  equipment sufficient to carry on properly the proposed project  detailed
  in the protocol or statement accompanying the application;
(c)  is  able  to  maintain effective control against diversion of the
  controlled substances for which the license is sought;
(d) is able to comply with all applicable state and federal  laws  and
  regulations  relating to the controlled substances for which the license
  is sought.
3. An application for a license or for an amendment to a license shall
  be accompanied by a detailed protocol setting forth:
(a) the nature of the proposed project;
(b) the proposed quantity or quantities of each  controlled  substance
  involved;
(c)  the  qualifications  and competence of the applicant to engage in
  such project;
(d) specific provisions for the safe administration or  dispensing  of
  controlled  substances  to  humans,  if  such  is  contemplated, and the
  proposed method of selecting humans;
(e) such other additional information as the commissioner may require.
4. The application for a license pursuant to this title shall  include
  copies  of  all  papers filed with the Bureau, the Federal Food and Drug
  Administration and any  other  governmental  agency,  whether  state  or
  federal, in connection with the applicant's proposed project.