PART 12—TELEMEDICINE FLEXIBILITIES Authority: 21 U.S.C. 802(54)(G). Source: 88 FR 30042, May 10, 2023, unless otherwise noted. Effective Date Note: At 88 FR 30042, May 10, 2023, part 12 was added, effective May 11, 2023 through Nov. 11, 2024. At 88 FR 69879, Oct. 10, 2023, the expiration date was extended to Dec. 31, 2024. Subpart A—Special Exceptions Related to Telemedicine § 12.1 Temporary extension of certain COVID-19 telemedicine flexibilities for prescription of controlled medications. (a) This section is in effect until the end of the day December 31, 2026. The authorization granted in paragraph (b) of this section expires at the end of December 31, 2026. (b) During the period May 12, 2023, through December 31, 2026, a Drug Enforcement Administration (DEA)-registered practitioner is authorized to prescribe Schedule II-V controlled substances via telemedicine, as defined in 21 CFR 1300.04(i), to a patient without having conducted an in-person medical evaluation of the patient if all of the conditions listed in paragraph (c) of this section are met. (c) A practitioner is only authorized to issue prescriptions for controlled substances pursuant to paragraph (b) of this section if all of the following conditions are met: (1) The prescription is issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice; (2) The prescription is issued pursuant to a communication between a practitioner and a patient using an interactive telecommunications system referred to in 42 CFR 410.78(a)(3); (3) The practitioner is: (i) Authorized under their registration under 21 CFR 1301.13(e)(1)(iv) to prescribe the basic class of controlled substance specified on the prescription; or (ii) Exempt from obtaining a registration to dispense controlled substances under 21 U.S.C. 822(d); and (4) The prescription is consistent with all other requirements of 21 CFR part 1306. [88 FR 30042, May 10, 2023, as amended at 88 FR 69883, Oct. 10, 2023; 89 FR 91257, Nov. 19, 2024; 90 FR 61306, Dec. 31, 2025] Effective Date Note: At 90 FR 61306, Dec. 31, 2025, § 12.1 was amended, effective Jan. 1, 2026 through Dec. 31, 2026. § 12.2 [Reserved] Subpart B—Telemedicine Prescribing Source: 90 FR 6523, Jan. 17, 2025, unless otherwise noted. § 12.3 Telemedicine prescribing of schedule III-V medications for the treatment of Opioid Use Disorder. (a) For purposes of this section, terms defined in 21 CFR part 1300, elsewhere in 21 CFR chapter II, or in 21 U.S.C. 802 and 829 shall have the definitions set forth therein. (b) A practitioner may issue a prescription for schedule III-V controlled substances listed in 42 CFR 8.12(h)(2) as approved by the Food and Drug Administration (FDA) for use in the treatment of Opioid Use Disorder (OUD), defined as the use of an effective medication such as buprenorphine to treat OUD, pursuant to a communication between the prescribing practitioner and the patient using an interactive telecommunications system, including an audio-only telecommunications system, as described in 42 CFR 410.78(a)(3), if the following conditions are met: (1) Prescription drug monitoring program review. (2) Time limit. (i) As authorized by 21 U.S.C. 829(e), including pursuant to any other form of telemedicine as defined in 21 U.S.C. 802(54) or pursuant to practices as determined by regulation issued pursuant to 21 U.S.C. 829(e)(3)(B); or (ii) After the prescribing practitioner has conducted at least one in-person medical evaluation of the patient, as defined in 21 U.S.C. 829(e)(2)(B). (3) PDMP inaccessible or unavailable. (4) Pharmacy identification requirement. (5) Prescription only for treatment of OUD. (6) Authorization to prescribe. (i) Authorized under 21 CFR 1301.13(e)(1)(iv) to prescribe the basic class of controlled medication specified on the prescription; or (ii) Exempt from obtaining a registration to dispense controlled substances under 21 U.S.C. 822(d). (7) Consistent with general prescription requirements. § 12.4 Telemedicine prescribing of schedule II-V medications by the Department of Veterans Affairs practitioners. A practitioner may prescribe controlled substance(s) to a patient via the practice of telemedicine under 21 CFR 1300.04(i)(7) if all the following conditions are met: (a) The practitioner is: (1) An employee or contractor of the Department of Veterans Affairs (VA) who is acting in the scope of such employment or contract, and registered under section 303(g) of the Controlled Substances Act (Act) (21 U.S.C. 823(g)) (21 CFR 1301.13) in any state or is utilizing the registration of a hospital or clinic operated by the VA registered under section 303(f); (2) Prescribing to a patient who has previously received, at any time, an in-person medical evaluation by any VA practitioner who at the time of the in-person medical evaluation was acting within the scope of their VA employment or contract and had prescribing authority, or would reasonably be expected to have prescribing authority based on their credentials ( e.g., e.g., (3) Not a contracted practitioner located outside a VA facility or clinic providing care via the community care network or conducting disability compensation evaluations; and (4) Prescribing a controlled substance(s) for a legitimate medical purpose in the usual course of professional practice, and in accordance with applicable Federal and State law(s). (b) Prior to prescribing, the practitioner must conduct a review of both the VA EHR, to include the VA's internal prescription database, and the PDMP data of the state in which the patient is located at the time of the telemedicine encounter (if the state has such a program) for controlled substance prescription(s) for the patient's previous twelve (12) months preceding the controlled substance prescription(s), or if less than a year of data is available, for the entire prescription period. (1) Should either the patient's VA electronic health record, to include the VA's internal prescription database, or the PDMP data of the state in which the patient is located at the time of the telemedicine encounter (if the state has such a program) be unavailable or non-operational, for any reason, the VA practitioner must limit the prescription to a 7-day supply. Once the VA's internal prescription database and the PDMP are available or operational, a review of the databases as outlined in this paragraph (b) must be completed to continue prescribing the controlled substance(s) to the VA patient. (2) If no PDMP exists in the state in which the patient is located at the time of the telemedicine encounter, the VA practitioner must review the VA internal prescription database prior to issuing a controlled substance prescription. A prescription may extend beyond 7 days under this circumstance. (3) The VA practitioner must annotate in the VA patient's EHR their attempts to access the PDMP data of the state in which the patient is located, and VA internal prescription database data. If the prescribing VA practitioner fails to access the PDMP data of the state in which the patient is located or VA internal prescription database data as described in paragraph (b)(1) of this section, the VA practitioner must annotate in the VA patient's EHR the dates and times that the VA practitioner attempted to gain access, the reason why the VA practitioner was unable to gain access, and any follow-up attempts made to gain access to the system. The attempts must be recorded in accordance with the VA's internal policies and recordkeeping requirements. (c) The controlled substance prescription(s) is otherwise in conformity with the requirements of the Act and 21 CFR chapter II. [90 FR 6539, Jan. 17, 2025]