The acquisition, use and disposal of Controlled Substances at UCSF is subject to strict Federal and State Drug Enforcement Administration (DEA) regulations as well as University of California directives. These regulations and directives set specific requirements and restrictions on registration, acquisition, usage, record keeping, transfer, storage and disposal. The purpose of this document is to establish the University of California, San Francisco (UCSF) controlled substance procedures which meet Federal, State and University of California (UC) requirements. Specific references to regulations and University of California mandates are listed in Appendix A.
Individuals who manufacture, distribute, dispense, import, export, conduct research or perform chemical analysis with any Controlled Substances including Precursor Chemicals are subject to a DEA registration. The UCSF campus (locations in San Francisco City and County) is registered with the DEA for all research activities involving Schedule II through V Controlled Substances. Research involving Schedule I drugs as well as the other activities referenced above require an independent registration directly with the DEA (OEH&S must be immediately notified of all independent Controlled Substance registrations obtained by UCSF campus personnel).
The Controlled Substances program provides services to all UCSF campus laboroatory activities and non-medical support facilities, inclyding those under contracts or grants. Refer to the Controlled Substances Manual for eligibility to participate in the program.
Controlled Substanece Compliance
To evaluate the effectiveness of the program, the Controlled Substance Officer will conduct random inspection of research labs which use Controlled Substances.
EH&S Environment, Health and Safety Specialists (DSAs) conduct unannounced annual laboratory audits for Controlled Substance during the third trimester. Inspections will cover the proper storage and recordkeeping of Controlled Substances as well as specific requirements identified during the registration process. The inspection is including the proper storage and recordkeeping of Controlled Substances as well as specific requirements identified during the Registration process.
The DEA may conduct random audits and inspections of the Controlled Substance Program. DEA inspector would be conducted in coordination with EH&S. DEA audits may include any and/or all administrative and operational aspects of the Program.
All laboratories (chemical, biological, and radiological) must undergo a laboratory clearance prior to being retired, remodeled, renovated, cleaned, or relocated*.
When performing a laboratory clearance involving controlled substances, the following procedures must be followed. For additional information, refer to the UCSF Controlled Substances Program Manual:
EH&S must confirm clearance is complete in all cases prior to retiring or modification of CSA.