The DEA Practitioner's Manual outlines specific recordkeeping requirements for practitioners who deal with controlled substances. The main points regarding these requirements are as follows:
General Recordkeeping:
- Complete and Accurate Records: Practitioners must keep up-to-date, complete, and accurate records of each controlled substance they purchase, receive, sell, store, distribute, dispense, or otherwise handle. This is laid out in 21 CFR 1304.21(a).
- Accountability: These records serve to trace controlled substances throughout their lifecycle, from manufacturing to final dispensing, helping to minimize the potential for diversion.
- Retention Period: All records concerning controlled substances must be kept for at least two years for inspection and copying by authorized DEA officials. This is mandated by 21 U.S.C. 827(b) and 21 CFR 1304.04(a).
Specifics Based on Scheduling:
- Schedule II: Records and inventories of Schedule II controlled substances must be maintained separately from all other records of the registrant, as specified in 21 CFR 1304.04(h)(1).
- Schedules III, IV, and V: Records for these schedules must be either kept separately or be readily retrievable from other business records. This is stated in 21 CFR 1304.04(h)(3).
Definition of "Readily Retrievable":
According to 21 CFR 1300.01(b), this term means that the records are either:
- Kept in an electronic format that can be quickly separated from other records.
- Visually identifiable from other items on the records, such as being asterisked or redlined.
Exemptions:
- Practitioners are generally not required to keep records for controlled substances prescribed in the regular course of professional practice, unless used for maintenance or detoxification treatment, according to 21 CFR 1304.03(c).
- If a practitioner administers controlled substances but doesn't regularly charge patients for such services, then they are not required to keep records for those administered substances, as per 21 CFR 1304.03(d).
Special Cases:
- Practitioners that dispense controlled substances have to maintain detailed records, including the quantity dispensed, the recipient's name and address, the date of dispensing, and the name or initials of the person who did the dispensing, as indicated in 21 CFR 1304.22(c).
In summary, the recordkeeping requirements are designed to ensure accountability and transparency in the handling of controlled substances. They also serve to aid in monitoring and auditing by authorized DEA officials.
CLICK HERE to read the DEA Practitioners Manual - Part 7: Procurement and Dispensing of Controlled Substances