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Prescribing Limitations on buprenorphine Removed

Mar 2, 2023 | Insights and Highlights

Elimination of the DEA X Waiver to Prescribe Buprenorphine, The Consolidated Appropriations Act of 2023 signed into law by President Biden on December 29, 2022, has amended the Controlled Substances Act (CSA) and enacted important changes in the medical treatment of opioid use disorder (OUD).

Starting with the Drug Abuse Treatment Act (DATA) of 2020, federal law required qualified practitioners (to be called “practitioners”) to obtain a waiver from the Drug Enforcement Agency (DEA) for their DEA registration – commonly called an X-waiver — to write buprenorphine prescriptions for up to 30 patients with OUD at a given time if the practitioners met certain eligibility criteria that included completion of required training on medications for addiction treatment (MAT) and the ability to provide or refer patients for counseling services. Additionally, federal law limited the number of patients a practitioner could treat with buprenorphine at one time to a maximum of 275.  And the Federal law changed several times since 2000 and the training and counseling requirements were removed for practitioners but the requirement of an X-waiver to prescribe buprenorphine and the limit on the number of patients a practitioner could treat at a given time remained.

The Consolidated Appropriations Act of 2023 removes these remaining limitations on buprenorphine prescribing and allows all healthcare providers, as permissible under state law, with a valid state license and a current DEA registration that includes Schedule III authority to prescribe buprenorphine for the treatment of OUD by:

  • Eliminating the requirement that practitioners apply for an X-waiver through the DEA
  • Eliminating the limit on the number of patients that practitioners can treat with buprenorphine at a given time.

Additionally, the law now requires all healthcare providers, with a few exceptions, who prescribe any controlled substances to complete required training in the identification and treatment of substance use disorders when any practitioner first applies for a DEA registration or at the time of their next DEA registration renewal. The training requirement becomes effective in June 2023.

More information about the removal of the X-waiver requirement can be found on the Substance Abuse and Mental Health Services Administration (SAMHSA) website: Removal of DATA Waiver (X-Waiver) Requirement | SAMHSA. Additionally, the DEA issued a letter to registrants about eliminating the X-waiver on January 12, 2023 t,hat can be found at:  https://www.deadiversion.usdoj.gov/pubs/docs/A-23-0020-Dear-Registrant-Letter-Signed.pdf Posted 1/19/2023