Use of Controlled Substances in Research

Laws and regulations regarding controlled substances and their designations are documented in the Controlled Substance Act of 1970, the Code of Federal Regulations (21 CFR, part 1300 to end), the State of Michigan, Public Health Code, Act 368 of 1978, Article Seven Controlled Substances (333.7101…333.7545), and the Michigan Board of Pharmacy, Administrative Rules-Controlled Substances R 338.3101-338.3199q.

Due to their potential for diversion and abuse, controlled substances are subject to extensive regulation regarding their manufacture, distribution, storage, record keeping, transfer, and disposal. The main regulating agencies governing controlled substances include the United States Department of Justice, Drug Enforcement Agency (DEA) and the Michigan Department of Community Health (MDCH), Board of Pharmacy.

Controlled substance regulations apply to all Principal Investigators and their authorized research staff utilizing controlled substances for the following: In vivo research approved by the University Committee for Use and Care of Animals (UCUCA) or chemical-analytical research.  Current regulations require an active State of Michigan controlled substance license and an active DEA registration for each principal place of business (as designated by laboratory street address) or professional practice where controlled substances are received, stored, distributed, and administered. Research involving controlled substances must be conducted at the physical location listed on an active State of Michigan controlled substance license and DEA registration.

Since a single State of Michigan controlled substance license and DEA registration cannot be maintained by the University, Principal Investigators performing analytical research or those with active UCUCA protocols requiring the use of controlled substances are responsible for obtaining a State of Michigan controlled substance research license and DEA researcher registration. In addition, Principal Investigators are responsible for maintaining secure controlled substance storage including restricted access, inventory records, acquisition records, administration records, disposal records, and other necessary documentation as required by federal and state regulations. To achieve compliance with all mandated regulations, it is recommended that the Principal Investigator registrant or a dedicated authorized user laboratory manager oversee these processes.

Polices regarding the use of controlled substances in animal or analytical research are separate from, and in addition to, policies regarding the use of controlled substances by practitioners as part of their professional practice or duties within the University of Michigan Health System (UMHS).  Medical practitioners cannot use their clinical controlled substance practitioner license or DEA practitioner registration to order, store, or administer controlled substances for animal or analytical research in their laboratories.

As of January 1, 2010, the Unit for Laboratory Animal Medicine (ULAM) will no longer supply controlled substances to Principal Investigators for research purposes. Researchers may obtain controlled substances through the University of Michigan Inpatient B2 pharmacy or through outside vendors.  ULAM will continue to provide non-controlled substances, such as antibiotics, non-steroidal anti-inflammatory drugs, xylazine, isoflurane, and miscellaneous supplies.

The Office of the Vice President for Research has designated a Controlled Substance Program Coordinator within the ULAM - UCUCA office to assist in matters relating to controlled substance licensing, registration, storage, record keeping, and disposal. The UCUCA office will monitor controlled substance storage requirements and record keeping compliance as part of their semi-annual laboratory inspections.

For more information please contact:

Dr. Patrick Lester, RPh, DVM, MS
Use of Controlled Substances in Research - Program Coordinator
Office (734) 936-4519
plester@umich.edu