N.Y. Comp. Codes R. & Regs. tit. 10 § 80.36

Current through Register Vol. 46, No. 45, November 2, 2024

Section 80.36 - Additional requirements, research, instructional activities and chemical analysis

(a) Persons engaged in research of controlled substances in schedules II to V shall first obtain a class 4 license from the department and thereafter a registration from the Drug Enforcement Administration, United States Department of Justice, or its successor agency.

(b) Persons engaged in industrial or commercial processes requiring the use of controlled, substances in schedules II to V shall first obtain a class 4a license from the department and thereafter a registration from the Drug Enforcement Administration, United States Department of Justice, or its successor agency.

(c) Persons engaged in instructional activities requiring the use of controlled substances in schedules II to V shall first obtain a license from the department in class 5 and thereafter, a registration from the Drug Enforcement Administration, United States Department of Justice, or its successor agency.

(d) Persons conducting research with controlled substances in schedule I shall apply to the department for such research license in class 7 and file with the department three copies of a research protocol describing the research project.

(1) The research protocol shall contain all pertinent information including the objective, material, security, procedures (such as species and number of animals, daily dose regimen and route of administration) and investigators, if any.

(2) If the commissioner finds that the applicant is qualified and competent, and has furnished a satisfactory protocol, the department shall license such applicant unless he finds that the application should be denied by reason of false statements in the application, conviction of a felony relating to controlled substances suspension, revocation, or denial of the applicant's Federal license or registration, failure to provide adequate safeguards against diversion of the controlled substances from legitimate medical or scientific use or other good and sufficient reason.

(e) A person licensed to conduct research with controlled substances listed in schedule I may conduct research with only such substances in schedule I for which he has filed and had approved a research protocol.

(f) All persons conducting research and instructional activities with controlled substances listed in schedule I shall first obtain a class 7 license from the department and thereafter, a registration from the Drug Enforcement Administration, United States Department of Justice, or its successor agency.

(g) All persons conducting analytical laboratories involving controlled substances shall first obtain a class 8 license from the department and thereafter, a registration from the Drug Enforcement Administration, United States Department of Justice, or its successor agency.

N.Y. Comp. Codes R. & Regs. Tit. 10 § 80.36