Buprenorphine (MOUD)

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[i], Congress eliminated the DATA-Waiver requirement. Specifically, Pub. L. No. 117-328, div. FF, tit. I(B), ch. 6, § 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). EO-DEA260, DEA-DC-067, March 22, 2023

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,[i] 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. EO-DEA263, DEA-DC-066, March 21, 2023

Question: How can a DATA-waived practitioner issue a buprenorphine prescription to a displaced patient with no home address?

Answer: DEA regulations require that a legitimate prescription must include the full name and address of the patient, in addition to other requirements of a valid prescription. 21 CFR 1306.05(a). DEA recognizes that on occasion extenuating circumstances may arise where a displaced patient has no permanent home address. In such cases, DEA advises the practitioner to communicate with the patient and determine the best address where the patient may be temporarily residing and annotate that address on the prescription.

In the alternative, a DATA-waived practitioner may order buprenorphine to dispense directly to a displaced patient. Any patient receiving either a buprenorphine prescription or a dispensed medication would be counted against the DATA-waiver limits of the practitioner. 21 CFR 1301.28. DATA-waived practitioners who are dispensing controlled substances from their registered locations must maintain dispensing records in compliance with 21 CFR 1304.22(c) and comply with all other Federal, State, local and tribal laws. EO-DEA172, October 5, 2020

Question: May a pharmacy deliver a prescribed buprenorphine product to a practitioner for direct administration to the patient?

Answer: Yes, but only in limited circumstances. Ordinarily, a prescription only authorizes a pharmacist to dispense a controlled substance to an ultimate user, which includes a patient or a member of the patient’s household. 21 U.S.C. 802(10) and (27); 21 CFR 1300.01 ("[p]rescription means an order for medication which is dispensed to or for an ultimate user"). However, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act) permits a pharmacy to deliver a controlled substance prescribed for maintenance or detoxification treatment to a practitioner’s registered location for the purpose of direct administration through either injection or implantation to a narcotic dependent person. 21 U.S.C. 829a(a).

The prescription must be issued by a qualifying practitioner who is authorized to prescribe controlled substances for maintenance or detoxification purposes under 21 U.S.C. 823(g)(2) and the prescription must meet the requirements of the Controlled Substances Act and DEA regulations, including the requirement that it may not be used to supply the practitioner with stock for general dispensing to patients. The pharmacy may deliver the controlled substance to the registered location of either the prescribing practitioner or the administering practitioner, and must be administered by injection or implantation only to the patient named on the prescription within 14 days after the date of receipt of the controlled substance by the practitioner. 21 U.S.C. 829a(a)(2)(B) and 829a(a)(5).

Notwithstanding any exceptions under 21 U.S.C. 827, a practitioner administering controlled substances must maintain complete and accurate records of all controlled substances delivered, received, administered, or otherwise disposed of under 21 U.S.C. 829a, including the persons to whom controlled substances were delivered. 21 U.S.C. 829a(a)(6). The pharmacy must maintain, for a period of at least two years, complete and accurate records of all controlled substances received, distributed, dispensed, or otherwise disposed of, including either, where applicable, the original paper prescription or an electronic prescription which is readily retrievable. See 21 CFR part 1304. The pharmacy must also comply with all other Federal, State, local and tribal laws in the jurisdiction in which they are licensed. See, e.g., 21 U.S.C. 829a(a)(3). Relatedly, nothing in this guidance document relieves any pharmacy or other entity that dispenses a buprenorphine product from any obligations that might arise under the Federal Food, Drug, and Cosmetic Act, such as those relating to an FDA-approved Risk Evaluation and Mitigation Strategy (REMS). EO-DEA220, September 18, 2020, DEA-DC-045

Disclaimer: Guidance documents, like this document, are not binding and lack the force and effect of law, unless expressly authorized by statute or expressly incorporated into a contract, grant, or cooperative agreement. Consistent with Executive Order 13891 and the Office of Management and Budget implementing memoranda, the Department will not cite, use, or rely on any guidance document that is not accessible through the Department's guidance portal, or similar guidance portals for other Executive Branch departments and agencies, except to establish historical facts. To the extent any guidance document sets out voluntary standards (e.g., recommended practices), compliance with those standards is voluntary, and noncompliance will not result in enforcement action. Guidance documents may be rescinded or modified in the Department's complete discretion, consistent with applicable laws.