You are here

Maintain Security & Storage Controls

The controlled substance licensee/registrant is responsible for applying effective internal controls to guard against theft and diversion of controlled substances; including screening personnel who may come in contact with substances and properly storing and securing the substances per schedule requirements. 

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

References and Resources

  • Authorized Personnel Log

    Template (Word) to track the individuals, other than the licensee/registrant, who are authorized to handle controlled substances for research use and/or access to the storage location.

  • U-M Authorized Personnel Screening Statement Form

    Internal attestation form (PDF) for personnel who will handle controlled substances for research purposes and/or have access to the storage location.

Controlled Substance Procedures