FDA clarifies pharmacist recommendations in Buprenorphine forOpioid Dependence REMS

FDA is notifying pharmacists that the recommendation in the Buprenorphine-containing Transmucosal products for Opioid Dependence (BTOD) REMS program for a pharmacist to “verify that the prescription you receive is from a prescriber who is in compliance with the provisions of DATA 2000” is no longer applicable. Pharmacists can dispense buprenorphine for opioid use disorder (OUD) to patients without such verification.

The Consolidated Appropriations Act of 2023 amended the Controlled Substances Act to eliminate the Drug Addiction Treatment Act of 2000 (DATA 2000) requirement, thus making the BTOD REMS program recommendation to verify DATA 2000 no longer applicable. DATA 2000 required health care practitioners who held a controlled substances registration with the Drug Enforcement Administration to apply for a waiver through the Substance Abuse and Mental Health Services Administration to prescribe buprenorphine for maintenance or detoxification treatment for OUD.

All product labeling for BTOD products is being updated along with modification to the REMS materials to reflect these changes.