DEA Minimum Standards for storage of Controlled Substances

These recommendations were collected from the drug Enforcement Administration (DEA) 

"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.

Minimum Standards for Practitioners' Handling of Controlled Substances

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:

  1. The number of employees, customers and/or patients who have access to the controlled substances.
  2. The location of the registrant (high or low crime area).
  3. Use of an effective alarm system.
  4. Quantity of controlled substances to be kept on hand.
  5. 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."

For more information visit:

https://www.deadiversion.usdoj.gov/pubs/manuals/sec/sec_req.htm

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