Section 3325. Authority to issue licenses; applications  


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  • 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.