Removal of Guidance Documents Related to Repeal of X-Waiver

By January 27, 2023Member News

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Dear DEA Registrant:
On December 29, 2022, President Biden signed into law the Consolidated Appropriations Act (CAA) of 2023, which amended the Controlled Substances Act to eliminate the “DATA-Waiver requirement,” previously codified in 21 U.S.C. 823. In light of this action, the following guidance documents have been rescinded and will no longer be posted on our website.
Question: Must a prescription for a schedule III, IV, or V narcotic drug approved by the Food and Drug Administration specifically for detoxification or maintenance treatment include the practitioner’s identification number (“X” number) issued by the Administrator in addition to a DEA registration number?
Answer: Yes, if a prescription is issued for the purpose of providing either maintenance or detoxification treatment to a patient, the prescription must include both the DEA registration number and your X number. See 21 CFR 1306.05(a)-(b), 1301.28(d)(3). EO-DEA108, October 21, 2020.
And,
Question: How does a DATA-waived practitioner remove the X Number assigned to a DEA registration when they no longer intend to administer, dispense, or prescribe buprenorphine and no longer need the DATA-waiver?
Answer: DATA-waivered practitioners who no longer intend to administer, dispense, or prescribe buprenorphine products for opioid use disorder, may submit a written request to the DEA Registration Unit to remove the X Number from their DEA registration. DATA-waived practitioners are physicians, nurse practitioners, physician assistants, and all other categories of qualified mid-level practitioners. These qualifying practitioners or qualifying other practitioners are defined at 21 U.S.C. 823(g)(2)(G)(iii) and 823(g)(2)(G)(iv), respectively. The request should include the registrant’s name, DEA registration number, address of the registered location, and a description of why they are making this request. EO-DEA126, November 17, 2021.
We hope this information is helpful. For additional information about changes DEA is implementing pursuant to the CAA, please see the January 12. 2023, Letter from Administrator Milgram, and monitor our website at the following link, Informational Documents. For information regarding DEA’s Diversion Control Division, please visit https://www.DEAdiversion.usdoj.gov. Please contact the Diversion Control Division Policy Section at ODLP@dea.gov if you seek additional assistance regarding this or any other matter.