Drug Enforcement Administration (DEA) rules and regulations pertaining to the inventory requirements for controlled substances. These are laid out in the Code of Federal Regulations (21 CFR) and the United States Code (21 U.S.C.).
Key Points of Inventory Requirements:
- Type of Count: For Schedule I and II substances, an actual physical count is required. For Schedule III-V, an estimated count is typically acceptable, unless the container holds more than 1,000 tablets or capsules, in which case an exact count is needed.
- Record Keeping: All inventory records must be kept for at least two years at the registered location and should be readily retrievable for inspection.
- Separation of Records: Inventory records for Schedule II substances must be kept separate from all other records. For Schedule III-V, the records must either be separate or readily retrievable from other records.
- Initial Inventory: On the date of first dispensing controlled substances, a practitioner is required to take an initial inventory. If no controlled substances are on hand, a record showing zero inventory can be made.
- Inventory Details: Inventories must include specific elements such as the date of the inventory, whether it was taken at the opening or close of business, names and forms of the substances, dosage units, and number of commercial containers, among other details.
- Biennial Inventory: After the initial inventory, a new one must be taken at least every two years. This subsequent inventory should record the same information as the initial one.
- Newly Controlled Substances: When a substance is newly classified as a controlled substance, it must be inventoried as of the effective date of this new classification if possessed by the registrant.
- Recommended but Not Required: The DEA suggests that the inventory also include the name, address, and DEA registration number of the practitioner, as well as the signature of the person or persons responsible for taking the inventory.
- Submission to DEA: It is not mandatory to submit a copy of the inventory to the DEA.
These rules ensure compliance with federal laws aimed at preventing the unauthorized distribution and misuse of controlled substances, while also making sure that these substances are available for legitimate medical and research purposes.
CLICK HERE to read the DEA Practitioners Manual - Part 3: Electronic Prescriptions for Controlled Substances.