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CONTROLLED SUBSTANCE OVERVIEW: SECURITY
All registrants/licensees must provide effective physical security controls and operating procedures to guard against theft and diversion of controlled substances. An overall evaluation of the security measures in place will be made by the DEA and the Michigan Bureau of Health Professions during the application review to ensure the controlled substances are stored securely.
- At a minimum, controlled substances in Schedule II-V must be stored in a securely locked, substantially constructed cabinet when not actively in use.
- Schedule I controlled substances must be stored in a securely locked, substantially constructed cabinet that is anchored to a wall or the floor.
- Only authorized agents may have access to controlled substances. Access should be restricted to the minimum number of employees needed.
- Carfentanil, etorphine hydrochloride, and diprenorphine must be stored in a safe or steel cabinet equivalent to a U.S. Government Class V security container.
- Controlled substances requiring refrigeration may be stored in a locked container securely fastened within a refrigeration unit.
The following factors, among others, are considered when evaluating the overall security system for a researcher:
- Type and form of controlled substances handled
- Quantity of controlled substances handled. Only the minimum amount of controlled substances needed for current research projects should be stored.
- Location of the premises and the relationship such location bears on security needs (high or low crime area)
- Extent of unsupervised public access to the area
- Number of employees and adequacy of supervision over employees who have access to the storage area
Other security measures
In order to minimize the opportunities for theft or diversion of controlled substances, the DEA feels researchers have an obligation not only to provide effective physical security, but also to initiate additional procedures to reduce access by unauthorized persons as well as to provide an alarm system where necessary.
Employee or Agent – A registrant must not employ an agent or individual who has had his or her application for registration with DEA denied or revoked at any time, and who, as a result of employment, will have access to controlled substances.
DEA Order Forms – Unused DEA Order Forms should be kept in a secure location to prevent theft.
For additional information regarding security requirements, refer to the DEA Controlled Substances Security Manual (www.deadiversion.usdoj.gov/pubs/manuals/sec/security.pdf).