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What is a Controlled Substance?
The federal Controlled Substance Act defines and classifies drugs and other substances into five (5) controlled substance schedules (I - V) according their potential for abuse and addiction. The substance's schedule dictates the appliction process to use and guidelines to follow for security, storage, etc.
Schedule I: illicit drugs, compounds and their chemical precursors that have a high potential for abuse, no accepted medical use, and lack of accepted safety protocols for medical use. They are typically used for drug abuse/addiction research or for analytical research.
Schedules II-V: drugs, compounds, and their chemical precursors that have accepted medical uses and a decreasing potential for abuse.
Schedule Lists & Definitions
- DEA schedule links (21 CFR, sections 1308.11-15)
- State of Michigan schedule links (PHC, 368-1978-7-72)
Controlled substance drugs are labeled with a C and the corresponding schedule number.
Research involving the use of controlled substances at the University of Michigan (U-M) is strictly regulated. U-M faculty who obtain, store, and utilize controlled substances in their research must:
- Obtain, as applicable, a State of Michigan (SOM) license and a U.S. Department of Justice – Drug Enforcement Administration (DEA) registration
- Record your approved license/registration in the U-M CSIR database
- Follow proper procedures when purchasing controlled substances
- Ensure proper security, storage, and disposal of controlled substances
- Adhere to federal, state and U-M policies, guidelines, and procedures regarding the use of controlled substances in research
The U-M Controlled Substances in Research compliance program provides guidelines and oversight monitoring to assist researchers in applying internal controls to comply with state and federal regulations.
Controlled Substances Research Review Committee (CSRRC)
The Controlled Substances Research Review Committee (CSRRC) provides guidance for conducting research with drugs or other substances that have potential for abuse which are subject to state and federal regulations. This guidance is reflected in U-M’s controlled substance research policy and procedures. The committee reviews any incidents involving controlled substances in research in order to assist the investigator in identifying and implementing corrective actions.
The committee meets monthly and consists of faculty from major units in which controlled substance are used in research and also key U-M administrators from across campus.
Researcher Roles & Responsibilities
To conduct research at U-M involving controlled substances, you must:
- Have your own active controlled substance SOM license and DEA registration, or
- Be approved as authorized personnel or an authorized agent under the license and registration of another U-M researcher
- List that licensee/registrant as a member of the study team on your animal and/or human subject research protocol
As an active SOM licensee/DEA registrant, you must:
- Properly store controlled substances per schedule requirements
- Properly screen and document as authorized personnel or authorized agent the U-M investigators and laboratory staff who will use the controlled substances for research under your license and registration
- Maintain at all times accurate and complete records per compliance regulations
- Immediately report any diversions of the controlled substances under your supervision
If you have a controlled substance practitioners license/registration, it is strongly recommended that you obtain a separate research license/registration to conduct research activity using controlled substances. This reduces risk to your medical or dental practice in cases of non-compliance with research per SOM or DEA policies.