Diversion Control Division, US Department of Justice, Drug Enforcement Administration

Practitioner's Manual - SECTION III

SECTION III – SECURITY REQUIREMENTS

Required Controls

Title 21, CFR Section 1301.71(a), requires that all registrants provide effective controls and procedures to guard against theft and diversion of controlled substances. A list of factors is used to determine the adequacy of these security controls. Factors affecting practitioners 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

Practitioners are required to store stocks of Schedule II through V controlled substances in a securely locked, substantially constructed cabinet. Practitioners authorized to possess carfentanil, etorphine hydrochloride and/or diprenorphine, must store these controlled substances in a safe or steel cabinet equivalent to a U.S. Government Class V security container.

Registrants should not employ as an agent or employee who has access to controlled substances:

  1. Any person who has been convicted of a felony offense related to controlled substances
  2. Any person who has been denied a DEA registration
  3. Any person who has had a DEA registration revoked
  4. Any person who has surrendered a DEA registration for cause

Lastly, practitioners should notify the DEA,upon discovery, of any thefts or significant losses of controlled substances and complete a DEA Form 106 regarding such theft or loss.

Safeguards for Prescribers

In addition to the required security controls, practitioners can utilize additional measures to ensure security. These include:

  1. Keep all prescription blanks in a safe place where they cannot be stolen; minimize the number of prescription pads in use.
  2. Write out the actual amount prescribed in addition to giving a number to discourage alterations of the prescription order.
  3. Use prescription blanks only for writing a prescription order and not for notes.
  4. Never sign prescription blanks in advance.
  5. Assist the pharmacist when they telephone to verify information about a prescription order; a corresponding responsibility rests with the pharmacist who dispenses the prescription order to ensure the accuracy of the prescription.
  6. Contact the nearest DEA field office (see Appendix E) to obtain or to furnish information regarding suspicious prescription activities.
  7. Use tamper-resistant prescription pads.

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