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URL:https://www.deadiversion.usdoj.gov/...ertificate_(Final).pdf
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Modified:2023-03-22 21:33:47
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Title:Drug Enforcement Administration Diversion Control Division Guidance Document
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Body:Drug Enforcement Administration Diversion Control Division Guidance Document Title: Updated DEA Registration Certificate after Removal of X-Waiver Summary: This guidance document provides information regarding issuance of updated Drug Enforcement Administration (DEA) registration certificates to reflect Congress's elimination of the X-waiver (DATA-Waiver) in the Consolidated Appropriations Act (CAA) of 2023. This guidance will be sent via email to all DEA-registered pharmacies and practitioners and will be posted on the DEA guidance portal. Activity: Updated DEA Registration Certificate after Removal of X-Waiver To Whom It Applies: All DEA-Registered Practitioners Question: In light of the elimination of the DATA-Waiver (X-waiver) requirement, do I need to take any action to get an updated DEA registration certificate? Answer: No action is needed on the part of registrants, as a result of the statutory repeal of 21 U.S.C. 823(h)(2). On December 29, 2022, with the signing of the CAA 1 , Congress eliminated the DATA-Waiver requirement. Specifically, Pub. L. No. 117-328, div. FF, tit. I(B), ch. 6, ยง 1262(a)(1), 136 Stat. 4459, 5681 (2022) removed the federal requirement for practitioners to apply for a special waiver prior to prescribing buprenorphine for the treatment of Opioid Use Disorder (OUD). It also removed the requirement for the assignment of an identification number (i.e., X- waiver number) associated with being a DATA-waived provider, for inclusion with the registration issued to the practitioner. 21 U.S.C. 823(h)(2)(D)(ii). If you are currently registered with DEA as a DATA-Waived (X-waiver) practitioner, you will be receiving an updated DEA registration certificate to reflect the elimination of your X-waiver unique identification number. Your existing (standard) DEA registration number will remain the same. No additional action is necessary on your part to remove the DATA-Waiver designation from your DEA registration. As DEA informed registrants by letter on January 12, 2023, "a DATA-Waiver registration is no longer required to treat patients with buprenorphine for opioid use disorder. Going forward, all prescriptions for buprenorphine only require a standard DEA registration number. The previously used DATA-Waiver registration numbers are no longer needed for any prescription." 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-DEA260, DEA-DC-067, March 22, 2023 1 Pub. L. No. 117-328, 136 Stat. 4459 (2022).