us-doj-guidance-DEA-DC-066•Elimination of Patient Limits for Prescribing Buprenorphine for Treatment of Opioid Use Disorder (OUD) under the Consolidated Appropriations Act (CAA) of 2023
Elimination of Patient Limits for Prescribing Buprenorphine for Treatment of Opioid Use Disorder (OUD) under the Consolidated Appropriations Act (CAA) of 2023
us-doj-guidance-DEA-DC-066Elimination of Patient Limits for Prescribing Buprenorphine for Treatment of Opioid Use Disorder (OUD) under the Consolidated Appropriations Act (CAA) of 2023Guidance
Drug Enforcement Administration Diversion Control Division Guidance Document Title: Elimination of Patient Limits for Prescribing Buprenorphine for Treatment of Opioid Use Disorder (OUD) under the Consolidated Appropriations Act (CAA) of 2023 Summary: This guidance document provides information regarding the elimination of limitations on the number of patients with OUD that a practitioner may treat with buprenorphine, as a result of Congress’s enactment of the CAA. This guidance will be sent via email to all Drug Enforcement Administration (DEA)-registered pharmacies and practitioners and will be posted on the DEA guidance portal. Activity: Prescribing Buprenorphine for OUD To Whom It Applies: All DEA-Registered Pharmacies and Practitioners Question: Are there any limitations on the number of patients with OUD that a practitioner may treat with buprenorphine after the passage of the Consolidated Appropriations Act of 2023 (CAA)? Answer: After enactment of the CAA,1 there are no longer limitations, under federal law, on the number of patients with OUD that a practitioner may treat with buprenorphine. On December 29, 2022, President Biden signed into law the CAA which expanded patient access to medications for OUD. Specifically, Pub. L. No. 117-328, div. FF, tit. I(B), ch. 6, § 1262(a)(1), 136 Stat. 4459, 5681 (2022) amended the Controlled Substances Act by repealing the “DATA-Waiver” requirement codified in 21 U.S.C. 823(g)(2), which had previously imposed limits or patient caps on the number of OUD patients a prescriber may treat with buprenorphine. These limits were previously outlined at 21 U.S.C. 823(g)(2)(B)(iii), and allowed qualified practitioners to treat up to 30, 100, or 275 patients at one time. Accordingly, previous patient limits under the DATA-Waiver Program no longer apply. However, practitioners are still required to comply with any applicable state limits regarding treatment of patients with OUD. Please check state laws for any limitations. You can find contact information for State Opioid Treatment Authorities here: https://www.samhsa.gov/medication- assisted-treatment/sota. The contents of this document do not have the force and effect of law and are not meant to bind the public in any way. This document is intended only to provide clarity to the public regarding existing requirements under the law or Department of Justice policies. EO-DEA263, DEA-DC-066, March 21, 2023 1 Pub. L. No. 117-328, 136 Stat. 4459 (2022).
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