N.Y. PBH Law § 3325

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