Security and 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 keep an updated Authorized Personnel Log on file that lists the authorized agents and authorized personnel at a registered location.

Denying access

Roswell Park Personnel shall follow its policies and procedures with regards to background check requirements, HR policy 201.1 “General Recruitment and Selection” and 1030.1 “Prevention of Drug Diversion."

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 and are securely separated within the unit
• 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 campus (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 - Download this Word template to track the individuals, other than the licensee/registrant, who are authorized to handle controlled substances for research use and/or have access to the storage location.
• Use of Controlled Substances in Research - Printable PDF version of the procedure