Practitioner's Manual - SECTION III
SECTION III – SECURITY REQUIREMENTS
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:
- The location of the premises and the relationship such location bears on security needs
- The type of building and office construction
- The type and quantity of controlled substances stored on the premises
- The type of storage medium (safe, vault, or steel cabinet)
- The control of public access to the facility
- The adequacy of registrant’s monitoring system (alarms and detection systems)
- 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:
- 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
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:
- Keep all prescription blanks in a safe place where they cannot be stolen; minimize the number of prescription pads in use.
- Write out the actual amount prescribed in addition to giving a number to discourage alterations of the prescription order.
- Use prescription blanks only for writing a prescription order and not for notes.
- Never sign prescription blanks in advance.
- 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.
- Contact the nearest DEA field office (see Appendix E) to obtain or to furnish information regarding suspicious prescription activities.
- Use tamper-resistant prescription pads.