Pharmacist FAQsFrequently Asked Questions for Pharmacists on Buprenorphine Products
Q: Do prescribers need an X registration number with DEA when prescribing buprenorphine for opioid use disorders? A: No. Prescribers no longer need an X registration number to prescribe buprenorphine for the treatment of opioid use disorders. CONGRESS ELIMINATES THE DATA-WAIVER PROGRAM AND THE REQUIREMENT FOR THE DATA-WAIVER “X” REGISTRATION NUMBERS ON PRESCRIPTIONS FOR BUPRENORPHINE FOR OPIOID USE DISORDER On December 29, 2022, with the signing of the Consolidated Appropriations Act of 2023 (the Act), Congress eliminated the “DATA-Waiver Program.” Section 1262 removes the federal requirement for practitioners to All practitioners who have a current DEA registration that includes Schedule III authority, may now prescribe buprenorphine for Opioid Use Disorder in their practice if permitted by applicable state law. North Carolina rules and laws do not conflict with this new authority for prescribing of buprenorphine for opioid use disorder with a current DEA registration. DEA put out an informational document that states: DEA fully supports this significant policy reform. In this moment, when the United States is suffering tens of thousands of opioid-related drug poisoning deaths every year, the DEA’s top priority is doing everything in our power to save lives. Medication for opioid use disorder helps those who are fighting to overcome opioid use disorder by sustaining recovery and preventing overdoses. At DEA, our goal is simple: we want medication for opioid use disorder to be readily and safely available to anyone in the country who needs it. The elimination of the X-Waiver will increase access to buprenorphine for those in need. All DEA registrants should be aware of the following:
Q: What are the new, one-time training requirements for DEA-registered practitioners to satisfy the Medication Access and Training Expansion Act (MATE Act) training requirement that will be tied to their initial or renewal DEA registration, effective June 27, 2023? A: The Drug Enforcement Administration (DEA) has outlined the requirements for DEA-registered practitioners to meet the new, one-time Medication Access and Training Expansion Act (MATE Act) training requirement that will be tied to their initial or renewal DEA registration, effective June 27, 2023. This requirement applies to practitioners holding individual DEA registrations. A pharmacist who is not an individual DEA registrant – i.e., practice pharmacy under the DEA registration of the employing pharmacy – is not required to obtain this training. But pharmacists such as Clinical Pharmacist Practitioners who are individual DEA registrants that prescribe controlled substances are subject to the requirement. In December 2022, Congress passed the Consolidated Appropriations Act of 2023 that included three bills to help manage and support patients with opioid or substance use disorder. The MATE Act, which was part of this legislation, requires new and renewing DEA-registered practitioners to complete a one-time, eight-hour training on opioid or other substance use disorders. Practitioners must affirm that they have completed this new training requirement on the date of their next scheduled DEA registration submission on or after June 27, 2023. There are three ways that practitioners may meet this requirement, which are outlined in DEA's letter. The letter also defines which accredited groups may provide training to meet the requirement, key points related to the training, and a list of practitioners who have been deemed as already satisfied the training. Recommendations for curricular elements in substance use disorders training is also available on the Substance Abuse and Mental Health Services Administration website. For more information on the MATE Act training requirements, please visit DEA's diversion control website. If you have any additional questions on this issue, please contact the Diversion Control Division Policy Section at ODLP@dea.gov or 571/362-3260.
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