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RESEARCH INVESTIGATOR HANDBOOK 3. OBTAINING REGULATORY COMMITTEE APPROVALS
• What is the controlled substance
program? What is the controlled substance program? The Controlled Substances Program is under the strict control of Federal and State Drug Enforcement Agency (DEA) regulations as well as University of California directives. These regulations and directives set specific restrictions and requirements on the registration, acquisition, usage, record keeping, transfer, storage and disposal of controlled substances as listed on the DEA drug scheduling list and the Controlled Substances Flow Chart. Contact your OEH&S Department Safety Advisor (DSA). The UCSF campus is registered with the DEA for all research activities involving Schedule II through V controlled substances including precursor chemicals. Schedule I substances require direct registration with the DEA. Once your research is approved for Schedule I substances, you must notify the OEH&S. This material will be added to your Controlled Substance Authorization (CSA) and is subject to OEH&S inspection. At UCSF, the OEH&S works with Material Management and Principal Investigators to regulate the distributions of all controlled substances. Research on controlled substances is considered unlawful under both Federal and State law if it does not have the appropriate approvals prior to obtaining the controlled substances. The University holds the license for controlled substances and has complete control over whether an investigator may order or initiate research with these substances. To work with controlled substances, you must have a Controlled Substance Authorization (CSA) approved by the Controlled Substance Program with the OEH&S. To apply for a CSA, complete the application form as well as other required information and submit it to your DSA. The program is described in the Controlled Substances Program Manual. If your research involves one of the following controlled substances, you must also obtain approval from the Research Advisory Panel of California (RAPC) for research involving:
Do not apply to the RAPC if you will be using Schedule II (in non-human research) III, IV or V controlled substances.
Is auditing or monitoring required? In order to keep controlled substances, they must be kept in a locked environment, have controlled access with strict monitoring of inventory and waste management. Tracking and training requirements are extensively detailed in the Controlled Substances Program Manual. Any modification in Controlled Substance Authorization concerning location, users, use, or type of controlled substance must be submitted to the OEH&S on the Universal Use Modification Request Form. Top tips to speed up the approval process and prevent problems:
Relevant policies and procedures
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