Record Keeping Requirements

Specific federal record keeping requirements apply for opioid dependency treatment with buprenorphine.

DEA record keeping requirements for buprenorphine treatment go beyond the Schedule III record keeping requirements. Under the Persons Required to Keep Records and File Reports, 21 Code of Federal Regulations (CFR) PART 1304.03, practitioners must keep records and inventories of all controlled substances dispensed, including approved buprenorphine products.

In some cases, patients return to the prescribing physician after receiving the approved buprenorphine product so that the physician can monitor them while they take the prescription. While it is acceptable for patients to return with their filled prescription, physicians should not store and dispense controlled substances that have been provided from prescriptions filled at pharmacies.

Last Updated: 09/09/2019