April 8, 2014
It may be beneficial to your readers if you review controlled substance storage requirements.
Dr. T, happy to oblige! Thank you for the inquiry.
The standards for storing controlled substances in a practitioners’ office are established by the Drug Enforcement Administration (DEA). According to the DEA website, substances must be stored in a “securely locked cabinet of substantial construction.” As the Federal regulations do not specifically define “substantial construction,” the adequacy of a given storage location is dependent on the surrounding factors. Some factors to be considered when evaluating the security of controlled substances include:
1. The location of the premises and the relationship such location bears on security needs
2. The type of building and office construction
3. The type and quantity of controlled substances stored on the premises
4. The type of storage medium (safe, vault, or steel cabinet)
5. The control of public access to the facility
6. The adequacy of registrant’s monitoring system (alarms and detection systems)
7. The availability of local police protection
Beyond that, practitioners are expected to create institutional procedures to reduce access to controlled substances, and to notify the DEA of any loss or theft.
The DEA also specifies that - Registrants should not employ as an agent or employee who has access to controlled substances:
- Any person who has been convicted of a felony offense related to controlled substances
- Any person who has been denied a DEA registration
- Any person who has had a DEA registration revoked
- Any person who has surrendered a DEA registration for cause
Of course unless a practitioner engages in background checks, this information would potentially elude them in their hiring practices.
States also have their own requirements. By way of example, NYS DOH has a listing of requirements and 10 NYCRR part 80 requires certain safeguards be in place -
Section 80.6 - Safeguarding controlled substances (a) Controlled substances shall at all times be properly safeguarded and securely kept at the address on file with the Drug Enforcement Administration and which is used in the ordering of the controlled substances, where they will be available for inspection by properly authorized officers, agents and employees of the New York State Department of Health, Bureau of Controlled Substances. (b) Access to controlled substances stocks shall be limited to the minimum number of employees actually required to efficiently handle the manufacture, distribution, custody, dispensing, administration or other handling of such substances. (c) The administrative head of a licensee hospital, laboratory, dispensary, nursing home and health-related facility and the supervisor of a manufacturer or distributor is responsible for the proper safeguarding and handling of controlled substances within the hospital or other facility. An administrative head or supervisor is not relieved of his responsibility to detect and correct any diversion or mishandling of controlled substances by a delegation of responsibility. (d) Persons operating pharmacies and supervising pharmacists of such pharmacies are responsible for the proper safeguarding and handling of controlled substances within the pharmacy. Persons operating pharmacies and supervising pharmacists are not relieved of their responsibility to detect and correct any diversion of mishandling of controlled substances by a delegation of responsibility.
Failing to abide by storage requirements may have a disastrous impact on your license, prescribing rights and life. I know, sounds extreme, but the reality is failing to abide by controlled substance requirements could lead to theft of such substances, misuse or other, which may lead to arrests, loss of licensure or other. So, take this is a friendly reminder to check your locks, cabinets, fridges and paperwork - check your prescription pads - lock them up!
Want a controlled substance check up? Contact Jennifer for a consult or in-office visit.
Tips to Operate Compliantly and Stay off the Radar Webinar - CLICK HERE TO VIEW ANY TIME
Recent Webinars -
Looking for HIPAA and compliance forms?
Check out our order form below or our website.
Interested in having Jennifer speak at an event or
at a residency/fellowship program?
Contact Jennifer directly at (516) 747-6700 x. 302 or at Jennifer@Kirschenbaumesq.com.