A. Program Administration

The University of California has responsibility for insuring that all activities concerned with acquiring, maintaining, storing, using, recordkeeping, and disposing of controlled substances and precursor chemicals for research purposes, as defined by the U.S. Drug Enforcement Administration, Department of Justice (DEA), are conducted in compliance with federal and State regulations. Business and Finance Bulletin BUS-50 describes implementation requirements for the campus, which includes designation of a Responsible Official and a Program Administrator (IDA 476 [superseded by IDA604] and IDA 477 [superseded by IDA605]).

At UCI, Environmental Health & Safety and Risk Services (EH&S) maintains the required institutional research registrations issued by the DEA and administers the Controlled Substances Program. The Controlled Substance (CS) Coordinator is responsible for oversight of all controlled substance and precursor chemical use for purposes of teaching, chemical analysis, and research at the UCI campus and UC Irvine Medical Center.

B. Definitions

1. Controlled substances have either a stimulant, depressant, or hallucinogenic effect on the nervous system. Controlled substances are prescription drugs that are further classified as Schedule I-V. The Controlled Substances Act (1970) listed substances that were controlled when the law was enacted. Since then, approximately 160 substances have been added, removed, or transferred from one schedule to another.
2. Precursor Chemicals, in addition to legitimate use, have the potential to be used in the manufacture of controlled substances. State and federal laws require our campus vendors to uphold stringent regulations regarding distribution of precursor chemicals to customers.

C. DEA Registration

DEA Registration is intended to identify and validate individuals and institutions that have been authorized by the DEA to purchase, possess, distribute or prescribe controlled substances.

1. An individual practitioner's DEA registration cannot be used to directly acquire controlled substances intended for research, instruction and chemical analysis purposes in University facilities.
2. University hospital, clinic and pharmacy DEA registrations are valid only for use of controlled substances at those licensed premises.

D. Obtaining a Controlled Substance Use Authorization for Controlled Substances and Precursor Chemicals

To comply with UCI acquisition, use, transport, storage, record keeping and disposal requirements, Principal Investigators must obtain a Controlled Substance Use Authorization prior to the acquisition or use of controlled substances and precursor chemicals for their own research.

A Controlled Substance Use Authorization is obtained when a researcher:

1. Completes online controlled substances training via the UC Learning Center.
2. Submits a Controlled Substance Use Authorization (CSUA) form.
3. Completes Appendix 1A, Principal Investigator Personnel Screening Sheet and answers questions concerning:
   1. Felony convictions in connection with controlled substances;
   2. Any use of narcotics, amphetamines, or barbiturates other than those prescribed to the applicant by a physician; and
   3. Surrendering previous registrations or having a registration revoked, suspended, or denied.
4. Additional authorized personnel working with or having access to controlled substances complete Appendix 2A – Personnel Screening Data Sheet and answer questions concerning:
   1. Felony convictions in connection with controlled substances;
   2. Any use of narcotics, amphetamines, or barbiturates other than those prescribed to the applicant by a physician; and
   3. Surrendering previous registrations or having a registration revoked, suspended, or denied.

E. Approved Use

Controlled substances and precursor chemicals may only be used in animals under an IACUC approved protocol and in human subjects under an IRB approved protocol. In-vitro researchers must submit a Controlled Substance Use Authorization (CSUA) application to the CS Coordinator for approval.

F. Acquisition

All acquisitions of controlled substances, whether provided by a private drug company or any other institution, must be:

• pre-approved by EH&S
• requisitioned through UCI Procurement Services as a high value purchase order requisition*; and
  * Use commodity code 51211900 and specify the Principal Investigator's name and department name in the 'Description' field in the 'Document Overview'
• delivered to the EH&S department prior to any transfer to researchers.

G. Delivery and Transport

The delivery point for all controlled substances and precursor chemicals ordered under UCI's departmental DEA research registration is the EH&S department on campus. Drugs may not be delivered directly to Controlled Substance Authorized Users. Principal Investigators may designate a research staff member that has completed all the required safety training and is listed in the PI’s Controlled Substance Use Authorization to pick up deliveries from the EH&S department on campus. A photo identification will be required to pick up all orders. Contact the Controlled Substances Program Coordinator at (949) 824-6200.

H. Storage

Federal regulations require the storage of controlled substances, dilute (controlled substances) solutions, and precursor chemicals, in a securely locked, substantially constructed cabinet. Controlled substances must be separated from other drugs, chemicals or items. Secure storage of both drugs and usage logs must be maintained.

I. Recordkeeping

Researchers are required by federal and state law to maintain records throughout a controlled substance's life cycle. Records must be kept secure in a locked area and retained for three years after disposal or termination of use. EH&S requires submission of annual renewals which will include an inventory update. Researchers who fail to complete and return the annual update by the requested date will have their Controlled Substance Use Authorization suspended until submission of the annual renewal or declaration of controlled substance use termination is received. These record keeping requirements are also applicable for dilute (controlled substances) solutions. Record keeping requirements do not apply to precursor chemicals.

J. Inspections

The DEA, in coordination with EH&S, may conduct random audits and inspections of UCI's Controlled Substance Program.

K. Theft

Any employee who has knowledge or reasonable suspicions of theft, significant loss of controlled substances, or alteration of records indicating drug loss must immediately report such information to the Principal Investigator, lab supervisor, and EH&S. The CS Coordinator is the designated liaison to the UCIPD and DEA.

L. Disposal

Controlled substances used by actively operating labs may not be transferred to another institution or another Principal Investigator. Upon permanent closure of a researcher's lab or termination of employment, disposal of all controlled substances is required.

Researchers are required by EH&S to schedule a pick up of expired or no longer needed drugs. To schedule a pickup of expired controlled substances or precursor chemicals that are no longer needed, submit the Request for Disposal.