THE OFFICE OF RESEARCH

NEW INVESTIGATORS: A QUICK GUIDE TO STARTING YOUR RESEARCH AT UCSF

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Obtaining Regulatory Committee Approvals - Other Topics:
| Making Sense of the Regulations | What is Research Online? | Working with Biologicals | Working with Chemicals | Working with Radioactive Materials | Working with Radioactive Materials in Humans | Working with Animals | Involving Human Subjects in Research | Serving on the Committees | Working with UCSF's Affiliates |

OBTAINING REGULATORY COMMITTEE APPROVALS

Working with controlled substances at UCSF

• What is the controlled substance program?
• Who do I contact?
• What approvals do I need?
• What resources are available?
• Is auditing or monitoring required?
• Top tips to speed up the approval process and prevent problems
• Relevant policies and procedures

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 UCSF flow chart.

Who do I contact?

Contact Robert Eaton in the OEH&S Controlled Substances Program at Purchasing (415) 502-8653, OEH&S and your 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 in approved for Schedule I substances, you must notify the OEH&S at UCSF. At UCSF, the OEH&S works with Materiel Management and Principal Investigators to regulate the distributions of all controlled substances.

What approvals do I need?

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 order or pick up these substances, you must have a Controlled Substance User Program Number assigned by the Controlled Substance Program under the oversight of the OEH&S. To obtain this number, you must enroll in the Controlled Substances Program at UCSF, contact Robert Eaton at 502-8653. 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:

•	Any Schedule I Controlled Substance, or
•	Schedule II Controlled substance for human research, or
•	Research for the treatment of drug abuse utilizing any drug, Scheduled or not

Do not apply to the RAPC if you will be using Schedule II (in non-human research) III, IV or V controlled substances.

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What resources are available?

•	DSA to advise and audit your facility
•	Controlled substance distribution office 476-1771
•	CSP contact number (Robert Eaton 502-8653)
•	Procedures to order controlled substances
	•	Flow Chart for UCSF
	•	Instructions (text)
•	Controlled Substances Manual
•	Controlled substance waste pickup by OEH&S
•	Research Online Inventory
•	Schedule of controlled substances – US Department of Justice Website
•	Materiel Management

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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 OEH&S on the Universal Use Modification Request Form.

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Top tips to speed up the approval process and prevent problems:

•	Consult with your DSA before submitting applications to the CSP
•	You must be able to strictly control access and track all inventory transactions per CSP regulations before you will be allowed to order and use controlled substances
•	You must have your inventory available to all auditors at all times
•	OEH&S Controlled Substances Disposal Service

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Relevant policies and procedures

•	Controlled Substance Program on the OEHS website
•	RAPC website (Research Advisory Panel)