Maintain Security & Storage Controls

Authorized Agents & Authorized Personnel

Authorized agents are designated by the licensee/registrant to oversee drug ordering, receiving, distribution to authorized personnel for research use, witnessing of drug waste, and maintaining access to the safe or locked cabinet. Keep agent status to a minimum number of staff to mitigate the risk of drug diversion.

Authorized personnel are faculty, staff, and/or students who are allowed to administer or handle controlled substances for research purposes under the authority and supervision of the licensee/registrant or authorized agent, when the licensee/registrant is unavailable. 

The licensee/registrant holds ultimate responsibility for restricting access to the controlled substances.  The licensee/registrant is required to:

1. Keep an updated Authorized Personnel Log on file that lists the authorized agents and authorized personnel at a registered location.  
2. Complete and keep on file a signed UM-Authorized Personnel Screening Statement Form for each authorized individual.  This form is based on the screening questions outlined in Title 21, CFR.1301.90 and helps ensure U-M is compliant with Title 21, CFR.1301.76(a). 

Denying Access

Deny access to controlled substances to any individuals with a known/confirmed:

• Controlled substance abuse problem (unless the individual is actively enrolled in a health professional recovery program with a current monitoring agreement)
• Suspended, revoked, denied, or surrendered-for-cause controlled substance license/registration
• Current sentence for the conviction of a crime that involves controlled substances

Secure Storage Requirements

Controlled substances must be stored with the following requirements to ensure compliance with Title 21, CFR.1301.72:

• Schedule I-II:  Securely locked, substantially constructed safe or steel cabinet that is anchored to a wall or the floor
• Schedule III-V: Securely locked, substantially constructed safe or steel cabinet

Note:    Schedule I-V substance can be stored together as long as security measures meet Schedule I-II requirements.

• Controlled substances requiring refrigeration must be locked in a container securely fastened within a refrigeration unit unless the refrigeration unit can be locked from the outside.

Portable storage boxes or storage in high-activity areas (e.g., corridors) are not allowed.

Best practices

• Anchor portable safes, steel cabinets, or refrigerators to the wall or floor for schedule III-V controlled substances.
• Do not leave controlled substances unattended
• Ensure two levels of security (e.g., locks) are in place and always used
• Reset locks, keys, or combinations when:
  • Authorized personnel leave the lab, department, or University (e.g., graduate, terminate employment, etc.)
  • Loss/theft is suspected or reported
• Maintain controlled substances in their original packaging