N.Y. Public Health Law § 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:
1. (a) and its managing officers are of good moral character;
2. (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;
3. (c) is able to maintain effective control against diversion of the controlled substances for which the license is sought;
4. (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:
1. (a) the nature of the proposed project;
2. (b) the proposed quantity or quantities of each controlled substance involved;
3. (c) the qualifications and competence of the applicant to engage in such project;
4. (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;
5. (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.