Controlled Substance Research Requirements

Policies

The University of Michigan expects that all faculty, staff and students who may come in contact with controlled substances during the conduct of research or instruction to comply with federal and State of Michigan regulations, and U-M policy.  These policies are listed below in References & Resources.

Exclusions

This U-M research policy does not apply to controlled substances dispensed to a patient by a licensed practitioner in the course of professional medical or dental practice.

Monitoring & Inspection

As part of federal and state regulations, and university controlled substance requirements, storage locations and laboratories are subject to external and internal inspections to verify compliance, safety, and security.

External

The U.S. Drug Enforcement Administration (DEA) conducts announced and unannounced inspections of the locations registered to store and use controlled substances. The licensee/registrant, authorized investigators, and U-M laboratory staff should be prepared at all times for such inspections by maintaining proper storage, security, and records.

Internal

The following U-M departments guide, provide, or participate in internal monitoring and inspection activity for the controlled substance research compliance program:

1.  UMOR - Controlled Substances in Research Oversight Monitors (CS Monitors)

The CS Monitors work closely with researchers, units and other U-M research compliance programs, e.g., Institutional Animal Care & Use Committee (IACUC) and the Department of Environment, Health & Safety (EHS) to ensure that:

• All research involving controlled substances meets the State of Michigan and the DEA regulations 
• U-M controlled substance policies and procedures are developed and maintained per state and federal regulations

They make laboratory visits to verify that U-M researchers are properly handling, storing, disposing of, and documenting controlled substances. The CS Monitors are your first point of contact for questions or concerns.

2.  IACUC – (link to standard operating procedure) as part of the post-approval monitoring for a protocol, when applicable

3.  EHS - (link to download the standard operating procedure) for disposal of controlled substances