Controlled Substances Security Manual
Security Requirements For Practitioners
Practitioners include physicians, dentists, veterinarians, researchers, hospitals, pharmacies, or other persons registered to do research, to dispense, or to use in teaching or chemical analysis a controlled substance in the course of professional practice.
Minimum security standards for practitioners are set forth in the regulations (Title 21 CFR 1300 to end) and are to be used in evaluating security. They may not necessarily be acceptable for providing effective controls and operating procedures to prevent diversion or theft of controlled substances. For example, a hospital that keeps large quantities of controlled substances on hand may need a safe or vault similar to the requirements for a distributor. The same reasoning also applies to other practitioners.
A practitioner's overall security controls will be evaluated to determine if they meet the intent of the law and regulations to prevent theft or diversion.
Controlled substances must be stored in a securely locked cabinet of substantial construction. Pharmacies have the option of storing controlled substances as set forth above, or concealing them by dispersal throughout their stock of non-controlled substances.
Even though the Federal regulations do not specifically define locked cabinet construction, the intent of the law is that controlled substances must be adequately safeguarded. Therefore, depending on other security measures, a wooden cabinet may or may not be considered adequate. In an area with a high crime rate, a strong metal cabinet or safe may be required.
Some of the factors considered when evaluating a practitioner's controlled substances security include:
- The number of employees, customers and/or patients who have access to the controlled substances.
- The location of the registrant (high or low crime area).
- Use of an effective alarm system.
- Quantity of controlled substances to be kept on hand.
- Prior history of theft or diversion.
Again, an overall evaluation of the practitioner's security will be made by DEA using the general and minimum security requirements as outlined in this manual to assure that the controlled substances are stored securely.
In order to minimize the opportunities for theft or diversion of controlled substances, practitioners 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 alarm system where necessary.
A practitioner must not employ an agent or individual who has had his application for registration with the Drug Enforcement Administration (DEA) denied or revoked at any time, and who, as a result of his employment, will have access to controlled substances.
A practitioner shall notify the nearest DEA Field Office of the theft or significant loss of any controlled substance upon discovery of such loss or theft. The practitioner shall promptly complete and submit DEA Form 106 regarding the theft or loss.
A practitioner should develop the practice of keeping blank prescription forms in locations which would preclude patients or casual visitors from stealing the forms for the purpose of falsification. Unused DEA Order Forms should also be kept in a secure location for the same reason.