Answer: Yes, but only in limited circumstances involving injected or implanted buprenorphine products. Buprenorphine is classified as a "controlled substance" under the Controlled Substances Act (CSA) and is an active ingredient in certain FDA-approved drug products or medications. Delivery by a pharmacy of prescribed buprenorphine products to a practitioner is not authorized for buprenorphine sublingual tablets, or for other buprenorphine products that are not administered through injection or implantation. 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 for maintenance or detoxification purposes. 21 U.S.C. 829a(a).

The prescription must meet the requirements of the CSA and DEA regulations, including the regulatory requirement that it may not be used to supply the practitioner with stock for general dispensing to patients. 21 CFR 1306.04(b). The pharmacy may deliver the controlled substance to the registered location of either the prescribing practitioner or the administering practitioner, and the controlled substance must be administered by injection or implantation only to the patient named on the prescription no later than 45 days after the date of receipt of the controlled substance by the practitioner. 21 U.S.C. 829a(a)(2) and 829a(a)(5).

Notwithstanding any exceptions under 21 U.S.C. 827, the prescribing practitioner, and the practitioner administering the controlled substance, as applicable, 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 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 laws (including the Federal Food, Drug, and Cosmetic Act), as well as State and local laws in the jurisdiction in which they are licensed. See, e.g., 21 U.S.C. 355-1 and 21 U.S.C. 829a(a)(3). EO-DEA220R1, June 2024, DEA-DC-045R1

Answer: Individual practitioners, or medical, surgical, or other specialty residents operating under the DEA registration of a hospital/clinic pursuant to 21 CFR 1301.22(c) are not required to apply for or maintain a DEA registration on an individual basis. Accordingly, individual practitioners operating under the DEA registration of a hospital/clinic do not have to attest to completing the CAA training, unless they are separately registered. The new training requirement in section 1263(a) of Division FF of the CAA went into effect on June 27, 2023, and applies to all qualified practitioners "as a condition of registration . . . beginning with the first applicable registration for the practitioner." 21 U.S.C. 823(l)(1). "First applicable registration" is defined as "the first registration or renewal of registration by a qualified practitioner . . . that occurs on or after [June 27, 2023]." 21 U.S.C. 823(l)(4). DEA-registered hospitals may consider providing opportunities for accredited training to residents and other practitioners who may be treating patients and prescribing medications for SUD while operating under the hospital's DEA registration. Section 1263 of the CAA allows for SUD training to count towards meeting the DEA training requirement if it occurred as part of medical school, nursing school, physician assistant school, or dental school within 5 years of an initial DEA registration application. Residency programs are part of training through accredited medical, nursing, physician assistant, or dental schools, and training provided by hospitals would meet the CAA training requirement.

For further background information please see the corresponding document that is in the DEA Guidance Document Portal. EO-DEA274, DEA-DC-80, February 14, 2024

Answer: Qualified practitioners may now prescribe buprenorphine for opioid use disorder (OUD) without a DATA-2000 waiver, as a result of legislation recently passed by Congress. On December 29, 2022, President Biden signed into law the CAA, 2023,^[1] which in part included provisions to expand patient access to medications for OUD. Specifically, the CAA, 2023 amended the CSA to eliminate the "DATA-Waiver requirement," which had been codified in 21 U.S.C. 823.

Prior to the CAA, 2023, DATA-waived practitioners were allowed to administer, dispense, and prescribe any schedule III, IV, or V narcotic drug approved by the Food and Drug Administration (FDA) specifically for use in maintenance or detoxification treatment to a person with an opioid use disorder (OUD) if the practitioner complied with the requirements found under 21 CFR 1301.28. This regulation detailed an exemption for practitioners from registration as a narcotic treatment program, or opioid treatment program, if the practitioner submitted notification to the Secretary of Health and Human Services (HHS) stating their intent to dispense or prescribe FDA-approved narcotic drugs, or opioid medications, for the treatment of OUD. Section 1262 of the CAA, 2023 removed the federal requirement for a practitioner to submit notification to the Secretary of HHS, and removed the other limitations previously applicable to DATA-waived practitioners.^[2] As of December 29, 2022, there is now no requirement that only DATA-waived practitioners can administer, dispense, or prescribe FDA-approved narcotic drugs, or opioid medications, for the treatment of OUD. DEA is in the process of amending its regulations and revising its guidance documents to reflect these statutory changes.

Section 1263(a) of the CAA, 2023 also amended the CSA by adding subsection (l) to 21 U.S.C. 823, which requires training for prescribers. Specifically, the new 21 U.S.C. 823(l)(1) provides that, "[a]s a condition on registration under this section to dispense controlled substances in schedule II, III, IV, or V, the Attorney General shall require any qualified practitioner, beginning with the first applicable registration for the practitioner to meet" certain conditions; the specific conditions are divided into a list if the practitioner is a physician and another list if the practitioner is not a physician. Section 1263(a) of the CAA, 2023 defines the term "qualified practitioner" as a practitioner who (i) is licensed under State law to prescribe controlled substances, and (ii) is not solely a veterinarian, under 21 U.S.C. 823(l)(4)(B). The term "first applicable registration" means the first registration or renewal of registration by a qualified practitioner on or after June 27, 2023, under 21 U.S.C. 823(l)(4)(A). Please see our DEA guidance portal for additional information on the training requirement.

As of June 27, 2023, all practitioners are required to attest to completing the CAA, 2023 training requirement when applying for an initial registration or renewing their registration. All practitioners, who are not solely a veterinarian, must satisfy the training, credentialing, or educational requirements identified in section 1263 of the CAA, 2023 in order to obtain a DEA registration. The deadline for attesting to this training requirement is the date of a practitioner’s next scheduled DEA registration submission – regardless of whether it is an initial registration or a renewal registration.

Therefore, any qualified practitioner can treat patients who screen positive for OUD with buprenorphine. This includes prescribing, administering, or dispensing buprenorphine with their DEA registration as long as there are no state regulations that prohibit (or limit) them from participating in this activity. DEA Registration numbers no longer indicate DATA-waivers, and prescriptions for buprenorphine no longer require the DATA-waivered or "x" waivered number on them, with the elimination of the DATA-waivered requirement in the CAA, 2023.

Both the CSA and the DEA regulations continue to require that a prescription for a controlled substance must be issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice. 21 CFR 1306.04(a).

Some pharmacies have been reluctant to fill prescriptions for buprenorphine and some wholesalers have limited distribution based on perceptions or fears that filling prescriptions or distributing buprenorphine may generate an investigation. As noted above, the intent of the MAT Act was to expand patient access to medications for OUD by eliminating regulations that limited access to medications. Therefore, it is expected that this will result in more prescribing of buprenorphine and dispensing of greater amounts of buprenorphine than in previous years.

While the practitioner is responsible for the proper prescribing and dispensing of controlled substances, a corresponding responsibility rests with the pharmacist who fills the prescription. 21 CFR 1306.04(a). 21 CFR 1306.06.

Additionally, prescribers and pharmacists should check state laws or contact their state pharmacy board for any limitations. EO-DEA261, DEA-DC-078, November 28, 2023

Answer: Yes, you can still use the existing forms. They DO NOT need to be returned to DEA. On December 29, 2022, with the signing of the CAA of 2023, Congress eliminated the DATA-Waiver requirement. Section 1262 of the CAA of 2023 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(g)(2)(D)(ii). DEA-registered practitioners, allowed to handle schedule I and II controlled substances, are issued DEA-Form 222s. These forms are printed by DEA with the practitioner's DEA registration number and registered location; however, no forms were printed with a practitioner"s X-waiver number. As the X-waiver numbers were not used previously to order controlled substances on DEA-Form 222s, no change is necessary. Orders for controlled substances are still placed using your DEA number only. DEA-registered practitioners who are allowed to handle schedule I and II controlled substances, may obtain and use DEA-Form 222s. 21 CFR 1305.04(a). EO-DEA265, DEA-DC-069, April 2, 2023

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

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

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