Use of Controlled Substances in Research and Instructional Activities Policy

Policy Category	Issuing Authority	Responsibility	Publication Date	Next Review Date
Research	Office for Research and Innovation	Office of Research Compliance	10/7/2025	10/7/2028

Policy Statement & Background:

None

Policy:

Certain research and instructional activities conducted under the auspices of this University require the use of controlled substances. Controlled substances are drugs or chemicals with a high potential for abuse, which are identified in one of five schedules found within the Controlled Substance Inventory List, published by the Drug Enforcement Administration (DEA) of the U.S. Department of Justice. 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 in Animal Research

Each principal investigator must be licensed with the State of New York Bureau of Narcotic Enforcement (BNE) and registered with the Drug Enforcement Administration (DEA) to conduct animal research with controlled substances (specifically those substances listed in schedules I-V). Those individuals who have obtained a license and registration, AND have Institutional Animal Care and Use Committee (IACUC), approval may purchase controlled substances for such purposes. Investigators who need these substances for routine veterinary use within Division of Laboratory Animal Resources (DLAR) facilities should contact the DLAR veterinarian.

Use of Controlled Substances in Patient Care Activities

The University Hospital, Dental Care Center and the University Health Service each hold 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 an appropriate DEA registration and a New York State license. 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 who serve as principal investigators of the research or instructional activities in which controlled substances are used are responsible for:

Obtaining and maintaining appropriate licensure from the NYS Department of Health.
Obtaining and maintaining appropriate registration with the Drug Enforcement Administration.
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.

Additional Requirements

Investigators are responsible for obtaining all applicable institutional approvals (e.g., Institutional Animal Care and Use Committee, Institutional Review Board, etc.). Applicants who are submitting research proposals to a sponsor for funding are required to report their intention to use controlled substances in myResearch Grants.

Definitions:

None

Contact:

Additional information about this policy is available here:

Office of Research Compliance

W5530, Frank Melville Jr. Memorial Library

Stony Brook, NY 11794-3368

Phone: (631) 632-9036

Fax: (631) 632-9839

https://www.stonybrook.edu/commcms/research-compliance/index.php