USE OF CONTROLLED SUBSTANCES IN P 206
RESEARCH AND INSTRUCTIONAL ACTIVITIES

Issued by: Office of the Provost
Replaces: P24, May 1977
Approved: May, 1991

Certain research and instructional activities conducted under the auspices of this University require the use of controlled substances. Controlled substances, which are drugs with high potential for abuse, are identified in the schedules contained within the "Controlled Substance Inventory List, published by the Drug Enforcement Administration (DEA) of the U. S. Department of Justice, and as listed in Chapter 878, Article 33 of the New York State Public Health Law entitled "Controlled Substance." Faculty, staff and students of the University must comply with all applicable state and federal laws and regulations that govern the procurement, use and documentation of controlled substances. The University reserves the right to conduct audits and inspections to assess such compliance.

Use of Controlled Substances Within the DLAR:

The Division of Laboratory Animal Resources (DLAR) is licensed to conduct research with controlled substances (specifically those substances listed in schedules II-V). DLAR purchases analgesics and anesthetics commonly used in animal care, some of which are controlled substances. Investigators having need for these substances for routine veterinary use within DLAR facilities may obtain them from DLAR staff. Anyone using controlled substances for any other purpose within DLAR must first obtain an individual license from the State and a registration from the DEA.

Use of Controlled Substances in Patient Care Activities:

The University Hospital, Dental Care Center and the University Health Service each holds institutional dispensing licenses that allow for controlled substance use in patient care activities conducted within those sites only. The activities of these facilities are governed by internal policies and procedures, and specific state and federal laws and regulations. Controlled substances for patient use may only be prescribed by faculty holding appropriate DEA and state registration. University Hospital house staff may prescribe controlled substances under the institutional registration after obtaining appropriate authorization.

Individual Licensure for Research and Instructional Activities:

Faculty members must obtain an individual license and registration for the use of controlled substances in research and instructional activities not covered under preceding sections unless they are members of a department that obtains a departmental license (see below). Faculty members who serve as either principal investigators or supervisors of the research or instructional activity in which controlled substances are used are personally responsible for:


Obtaining and maintaining appropriate licensure from the NYS
Department of Health

Obtaining and maintaining appropriate registration with the
Drug Enforcement Administration

Submitting copies of the license and registration to the
University Coordinator for Research Compliance each time
they are issued or renewed

Complying with all state and federal laws and regulations
pertaining to such use of controlled substances, including
license/registration restrictions, and requirements
regarding physical and other security, disposal of outdated
stock, and inventory and record-keeping procedures.

Departmental Licensure:

Departments with a number of faculty working with controlled substances may find it efficient to obtain licensure at the departmental level. The department then assumes the responsibilities listed above. Details may be obtained from the University Coordinator for Research Compliance.

Additional Requirements:

Investigators are responsible for obtaining approval for the research or instructional activity in which controlled substances are used from all applicable campus committees (e.g. Institutional Animal Care and Use Committee, Committee on Research Involving Human Subjects). Applicants who are submitting research proposals to a sponsor for funding are required to report their intention to use controlled substances in the relevant section of the Office of Research Services' form "Application for Grant or Contract" (SUSB 299).

INQUIRIES/REQUESTS:

Office of Research Compliance
632-9036

RELATED FORMS:

SUSB 299 Application for Grant or Contract SUSB 637 Application for Approval of Research
Involving Human Subjects SUSB 1750 Research Support Request

RELATED DOCUMENTS:

11 NYS C.R.R. Title 10 Part 80: Rules and Regulations on Controlled Substances Code of Federal Regulations, Title 21 Laws of New York, 1972

Code of Federal Regulations, Title 21 Laws of New York, 1972

Investigator's Guide to DLAR Services, Laws, Policies and Accreditation Standards Regarding Animal Use (USB)

Administrative Policies and Procedures Manual (University Hospital) Policies and Procedures of the Student Health Services

Pharmacy Department Policy & Procedure (University Hospital): 11-13, 15, 20, 21

Nursing Policy & Procedure (University Hospital): VI-04, 05