42 C.F.R. § 12.1

Current through September 30, 2024
Section 12.1 - [Effective until 12/31/2024] 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, 2024. The authorization granted in paragraph (c) of this section expires at the end of December 31, 2024.
(b) For purposes of this section, a practitioner and a patient have a telemedicine relationship established via COVID-19 telemedicine prescribing flexibilities if:
(1) The practitioner has not conducted an in-person medical evaluation of the patient; and
(2) The practitioner has prescribed one or more controlled substances to the patient
(i) Pursuant to the designation on March 16, 2020, by the Secretary of Health and Human Services, with concurrence of the Acting DEA Administrator, that the telemedicine allowance under 21 U.S.C. 802(54)(D) applies to all schedule II-V controlled substances in all areas of the United States for the duration of the nationwide public health emergency declared by the Secretary of Health and Human Services on January 31, 2020, as a result of the Coronavirus Disease 2019 pursuant to the authority under section 319 of the Public Health Service Act (42 U.S.C. 247 ); or
(ii) Pursuant to paragraph (c) of this section.
(c) During the period May 12, 2023, through December 31, 2024, 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 (e) of this section are met.
(d) During the period November 12, 2023 through November 11, 2024, a 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 with whom the practitioner has a telemedicine relationship established via COVID-19 telemedicine prescribing flexibilities without having conducted an in-person medical evaluation of a patient if all of the conditions listed in paragraph (e) of this section are met.
(e) A practitioner is only authorized to issue prescriptions for controlled substances pursuant to paragraphs (c) or (d) 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.

42 C.F.R. §12.1

88 FR 30042, May 10, 2023, as amended at 88 FR 69883, Oct. 10, 2023
88 FR 30042, 5/11/2023; 88 FR 69883, 11/11/2023 through 12/31/2024