Controlled Substance Program Overview

Overview

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.

 

Laboratory Clearance

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:

  1. Intent to dispose: Submit completed “UCSF Controlled Substances Schedule II / Schedule III-V Disposal Request Form” to EH&S.
  2. Intent to transfer: Submit written request for transfers of controlled substances to Controlled Substances Officer (CSO). Receiving Principal Investigator (PI) must have current Controlled Substances Authorization (CSA) and same Drug Enforcement Agency (DEA) registration (same campus location). Indicate amount transferred for each vial on Controlled Substances Transfer form. Refer to UCSF Controlled Substances Program Manual, Sec. K.
  3. Intent to retire: Submit in writing intent to retire CSA to CSO. Dispose all controlled substances and submit online inventory indicating “zero quantity.”
  4. Relocation:  Authorized user listed in the CSA may transport controlled substances to new location within the same DEA registration. If this is not the case, contact CSO for assistance. CSA must be modified to reflect new location.
  5. Empty vials: Dispose of unused or expired controlled substances as well as empty vial containers through EH&S.  If there is no usable amount of controlled substance left in a vial, the empty vial can be disposed in the regular trash after defacing the label.

EH&S must confirm clearance is complete in all cases prior to retiring or modification of CSA.

 

*Refer to the EH&S Move Guide for complete information regarding major relocations to another building.