How to Make Your Practice DEA Compliant: Best Practices for Storing Controlled Substances
If the DEA inspected your practice tomorrow, would your storage of controlled substances pass muster? Here’s what you need to know to be secure and compliant.
Healthcare professionals often ask us, “What should I be aware of when dealing with controlled substances?” The Drug Enforcement Administration (DEA) has provided rules and regulations surrounding controlled substances, and it can often seem excessive and confusing. But following these requirements is crucial for all practices that wish to dispense controlled substances.
How to Properly Store Controlled Substances
Security requirements depend on the type of storage your practice uses. The requirements apply to both Schedule I and II controlled substances as well as Schedule III, IV, or V.
Safe or Steel Cabinet
If you store your substances in a safe or steel cabinet and it weighs less than 750 pounds, the DEA requires it to be either bolted or cemented to the floor or wall in a way that prevents it from being easily removed. The DEA also requires the safe or steel cabinet to also be able to sustain outside entry (i.e., be able to prevent ten man-minutes of forced entry).
If your practice utilizes a vault made after 1971:
- The walls, floors, and ceilings must be constructed of at least eight inches of reinforced concrete or other substantial material, reinforced with 1.5-inch steel rods tied six inches on center, or the structural equivalent to such reinforced walls, floors, and ceilings.
- The door and frame unit must be able to prevent against 30 man-minutes of surreptitious entry, ten man-minutes of forced entry, 20 man-hours of lock manipulation, and 20 man-hours of radiological techniques.
- The vault must have either the walls or perimeter be equipped with an alarm. If the vault has been accessed without permission, the alarm must transmit a signal directly to a central station protection company, or a local or state police agency, or a 24-hour control station. And if necessary, the vault must have holdup buttons at strategic points of entry to the perimeter area of the vault.
- The door of the vault must be equipped with contact switches.
- The door must have one of the following: complete electrical lacing of the walls, floor, and ceilings; sensitive ultrasonic equipment within the vault; a sensitive sound accumulator system; or such other device designed to detect illegal entry.
If your practice regularly uses the vault, and thus wants to leave the vault open for frequent access, the DEA requires your practice to get a “day-gate,” which is self-closing and self-locking.
Additional Requirements for Schedule III, IV, or V Controlled Substances
If your practice uses Schedule III, IV, or V controlled substances, the DEA has the same requirements for safes, steel cabinets and vaults as with Schedule I and II. However, Schedule III, IV, and V have additional requirements.
For the building used for storage, the perimeter security that allows for limited access during working hours and provides security must:
- Have an electronic alarm system which will transmit a signal directly to a central station protection agency or a local or state police agency, or to a 24-hour control station, if there is any unauthorized entry.
- Be equipped with self-closing, self-locking doors constructed of substantial material equal with the type of building construction. If your practice does not have a self-closing, self-locking door, the door must be kept closed and locked at all times when not in use, and when in use is kept under direct observation by a responsible employee
- Doors may be sliding or hinged.
- But if hinges are mounted on the outside, they must be sealed, welded, etc. to inhibit removal. Locking devices must either be a multiple-position combination or key lock type and:
- For key locks, must have key control that limits access to a certain number of employees, or;
- For combination locks, the combination shall be limited to a minimum number of employees and can be changed upon the termination of an employee who has knowledge of the combination.
Multiple Storage Areas
Your practice may have multiple storage areas for your controlled substances. However, every area must comply with the DEA’s requirements.
Can Your Storage Area Be Accessible to Employees?
The storage areas should only be accessible to the minimum number of specifically authorized employees. Your practice should not have easy access to the controlled substances storage area unless necessary and the individual is given the appropriate supervision.
What Should Your Practice Do?
The DEA requirements can seem tedious and time-consuming, but they are necessary for establishing a safer, better practice. Review your practice’s current set-up to see if you comply with all the DEA’s rules, and if not, implement the suggestions listed above.
For help developing a controlled substances policy that addresses all of the regulatory requirements, enlist an experienced healthcare attorney such as Jackson LLP. Schedule a free consultation to learn more.