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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:
- Keep an updated Authorized Personnel Log on file that lists the authorized agents and authorized personnel at a registered location.
- 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).
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
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.
- 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