A dentist who stores controlled substances must follow both state and federal rules for storage, inventory and disposal of those drugs. DEA registration is required for each address where a dentist stores controlled substances.
Store controlled substances in a securely locked, substantially constructed cabinet. The DEA uses a list of factors to determine the adequacy of security:
Location of the premises and the relationship such location bears on security needs.
Type of building and office construction.
Type and quantity of controlled substances stored on the premises.
Type of storage medium (safe, vault or steel cabinet).
Control of public access to the facility.
Adequacy of registrant’s monitoring system (alarms and detection systems).
Availability of local police protection.
Maintain a log of drugs stored and retain information on the log for no less than three years.
Take inventory of controlled substances at least once every two years and include controlled substance samples provided by pharmaceutical companies in the record. The inventory record must be in a handwritten, typewritten or printed form and be maintained at the practice for at least two years from the date that the inventory was conducted. Each inventory record must contain the following information:
Whether the inventory was taken at the beginning or close of business
Names of controlled substances
Each finished form of the substances, e.g., 100-milligram tablet
The number of dosage units of each finished form in the commercial container, e.g., 100-tablet bottle
The number of commercial containers of each finished form, e.g., four 100-tablet bottles
Disposition of the controlled substances
Clinics, but not private dental practices, that are licensed under Business & Professions Code section 4180 or 4190 are required to follow new state inventory regulations that became effective in April 2018. Those regulations are found in Title 16 California Code of Regulations section 1715.65.
The theft or loss of controlled substances from a prescriber’s premises must be reported to local law enforcement and to the DEA. Report the theft or loss to the DEA using Form 106, available at www.deadiversion.usdoj.gov/21cfr_reports/theft.
Dispose of out-of-date, damaged or otherwise unusable or unwanted controlled substances, including samples, by transferring them to an entity that is authorized to receive such materials. These entities are referred to as “reverse distributors.” Contact your local DEA field office for a list of authorized reverse distributors. Mail-back programs are also available. Schedule II controlled substances should be transferred using DEA Form 222, while Schedule III, IV and V compounds may be transferred via invoice. Maintain copies of the records documenting the transfer and disposal of controlled substances for two years.
Prescribers should encourage patients to properly dispose of their unused or expired controlled substances through their local pharmacy or take-back event sponsored by local law enforcement. The DEA amended regulations in September 2014 to allow retail pharmacies, hospitals and clinics with pharmacies to collect the drugs from the ultimate users and to place collection containers at long-term care facilities.