Controlled Substances
- Program Explanation
- OEHS Oversight
- Controlled Substances Protocols
- Inspections
- Program Documents
- Controlled Substances User Forms
- Additional Controlled Substance Links
- OEHS Contact Information
Program Explanation
Due to their potential for misuse and abuse, scheduled drugs (controlled substances) listed by the US Department of Justice, Drug Enforcement Administration (DEA) and/or the Michigan Department of Licensing and Regulatory Affairs (LARA), are subject to strict regulation. These rules are aimed at preventing diversion of controlled substances through a variety of administrative and physical controls, including; special procurement, storage, use, and disposal requirements.
It is the responsibility of individual researchers and staff ordering and using these materials to obtain appropriate registrations and licenses. Researchers must obtain federal and state licensing (prior to procurement), maintain detailed storage and use records, and follow proper disposal procedures. The WSU Controlled Substances Program Description and the Forms provided below are intended to assist researchers in maintaining compliance with state and federal regulations.
The WSU program description does not apply to Wayne State University faculty and research staff members who hold individual DEA research registration and State of Michigan controlled substance license for the use of controlled substances associated with human research subjects in a clinical setting.
OEHS Oversight
Controlled Substances Protocols:
OEHS requires all WSU Principal Investigators (PIs) that are subject to the WSU Controlled Substance Program and who possess a State of Michigan License and DEA registration maintain an approved Controlled Substances protocol via the eProtocol platform.
Detailed information on this process is located on the Controlled Substances Protocol Preparation and Submission website.
Inspections:
OEHS will annually audit the recordkeeping, inventory, security, and disposal of CS used in research by Wayne State University faculty and research staff members. Reviews will be conducted to assure the university's compliance with DEA and State of Michigan regulations and the WSU program. If deficiencies are identified during an audit, subsequent audits may be performed more frequently to assist with adherence to regulatory compliance.
Program Documents
- WSU Controlled Substances Program Description (PWSU Controlled Substances Program Description - Printable)
- State of Michigan License Application Information (Printable)
- DEA Registration Application Instructions (Schedule II-V) (Printable)
Controlled Substance User Forms
- Initial Inventory Form (Printable)
- Authorized User Form (Printable)
- Purchase/Receipt Log (Printable)
- Annual Controlled Substance Inventory (Printable)
- Controlled Substance Usage Log - animal research (Printable)
- Controlled Substance Diluted Solution Usage Log - animal research (Printable)
- Controlled Substance Usage Log - non-animal related research (Printable)
- DEA Form 41: Destruction of Controlled Substances (Printable)
Additional Controlled Substance Links
- State of Michigan Application for Controlled Substance Research License
- Drug Enforcement Administration Controlled Substance Registration Application
- U.S. DEA Office of Diversion Control
- Federal Regulations: Title 21 Regulations
- Michigan Act 368 of 1978 Public Health Code: Article Seven Controlled Substances
- Controlled Substance Schedules
OEHS Contact Information
Contact Diane Gilbert, OEHS at 313-577-9507 (Office) or dgilbert@wayne.edu for more information.
Alternatively, call the OEHS Main Line on 313-577-1200