Question: When can a qualified practitioner start prescribing buprenorphine for opioid use disorder (OUD) without a DATA-2000 waiver?
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, 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. 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
Question: What changes can be made to a schedule II paper prescription?
Answer: In the past few months, DEA has received an increasing number of questions concerning pharmacists’ ability to add or modify information—like a patient’s address—on paper prescriptions. To address these questions, DEA has been reviewing the relevant regulations and working to draft new regulations to address this issue. In the interim, pharmacists should adhere to state regulations or policy regarding those changes that a pharmacist may make to a schedule II prescription after oral consultation with the prescriber. EO-DEA257, DEA-DC-063, October 18, 2022
Question: Does the CSA or DEA regulations prohibit DEA-registered practitioners or mid-level practitioners from issuing controlled substance prescriptions for personal use of the prescriber, friends, or family members?
Answer: No. However, practitioners and mid-level practitioners should be aware when prescribing controlled substances for personal use of the prescriber, friends, and family members, that the CSA and DEA regulations require that a prescription for a controlled substance be issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice. The practitioner is responsible for the proper prescribing and dispensing of controlled substances, but a corresponding responsibility rests with the pharmacist who fills the prescription. An order purporting to be a prescription that is not issued for a legitimate medical purpose in the usual course of professional treatment or in legitimate and authorized research is not a prescription within the meaning and intent of 21 U.S.C. 829. The person knowingly filling such a purported prescription, as well as the person issuing it, shall be subject to the penalties provided for violations of the provisions of law relating to controlled substances. 21 U.S.C. 841(a)(1) and 21 CFR 1306.04(a). Further, a prescription may not be issued in order for an individual practitioner to obtain controlled substances for supplying the individual practitioner for the purposes of general dispensing to patients. 21 CFR 1306.04(b). In addition, prescribing practitioners and mid-level practitioners must comply with applicable State, Federal, and local laws which may prohibit such activity. 21 U.S.C. 823(f)(4). 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-DEA099, October 4, 2022
Question: Can I send electronic controlled substance prescriptions to a pharmacy via e-mail?
Answer: No. "An electronic prescription"—that is, "a prescription that is generated on an electronic application and transmitted as an electronic data file"—must "be created and signed using an application that meets the requirements of part 1311 of this chapter." 21 CFR 1300.03, 1306.05(e). These requirements include, among other things, an audit or certification to ensure that the application "records, stores, and transmits" the necessary information "accurately and consistently," the capability to "[l]ink each registrant, by name to at least one DEA registration number," logical access controls "set by individual user name or role" that limit permissions for "signing controlled substance prescriptions," the ability to "accept two-factor authentication," and digital signature functionality that satisfies the relevant Federal Information Processing Standards (FIPS) developed by the National Institute of Standards and Technology. 21 CFR 1300.03, 1311.120(b). E-mail does not satisfy these requirements. EO-DEA094, DEA-DC-049, November 20, 2020
Question: May a prescription be issued in order for a practitioner to obtain controlled substances for dispensing to patients?
Answer: No. See 21 CFR 1306.04(b), "A prescription may not be issued in order for an individual practitioner to obtain controlled substances for supplying the individual practitioner for the purpose of general dispensing to patients." EO-DEA098, October 19, 2020
Question: I write controlled substance prescriptions to my patient. Does Federal law require that I see the patient every 30 days?
Answer: No. Neither the CSA nor DEA regulations require a practitioner to see a patient every 30 days. Nonetheless, the CSA and DEA regulations do require that a prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice. See 21 CFR 1306.04(a). As DEA has previously stated, "practitioners who prescribe controlled substances must see their patients in an appropriate time and manner so as to meet their obligation to prescribe only for a legitimate medical purpose in the usual course of professional practice and to thereby minimize the likelihood that patients will abuse, or become addicted to, the controlled substances." Issuance of Multiple Prescriptions for Schedule II Controlled Substances, 72 FR 64921, 64928 (2007). EO-DEA093, June 23, 2020
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.