```

[Federal Register Volume 89, Number 223 (Tuesday, November 19, 2024)]
[Rules and Regulations]
[Pages 91253-91257]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-27018]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1307

[Docket No. DEA-407]
RIN 1117-AB40, 1117-AB78, and 1117-ZA06

DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 12

Third Temporary Extension of COVID-19 Telemedicine Flexibilities 
for Prescription of Controlled Medications

AGENCY: Drug Enforcement Administration, Department of Justice; 
Substance Abuse and Mental Health Services Administration, Department 
of Health and Human Services.

ACTION: Temporary rule.

-----------------------------------------------------------------------

SUMMARY: The Drug Enforcement Administration (DEA) in concert with the 
Department of Health and Human Services (HHS) is issuing a third 
extension of telemedicine flexibilities for the prescribing of 
controlled medications, through December 31, 2025.

DATES: This rule is effective January 1, 2025, through December 31, 
2025.

FOR FURTHER INFORMATION CONTACT: Heather E. Achbach, Diversion Control 
Division, Drug Enforcement Administration; Mailing Address: 8701 
Morrissette Drive, Springfield, VA 22152, Telephone: (571) 776-3882.

SUPPLEMENTARY INFORMATION:

I. Background

Overview

    Under the Ryan Haight Online Pharmacy Consumer Protection Act of 
2008 (the Ryan Haight Act), a prescribing practitioner--subject to 
certain exceptions--may prescribe controlled medications to a patient 
only after conducting an in-person evaluation of that patient. In 
response to the COVID-19 Public Health Emergency (COVID-19 PHE), as 
declared by the Secretary (the Secretary) of the Department of Health 
and Human Services (HHS) on January 31, 2020, pursuant to the authority 
under section 319 of the Public Health Service Act (42 U.S.C. 247), the 
Drug Enforcement Administration (DEA) granted temporary exceptions to 
the Ryan Haight Act and DEA's implementing regulations under 21 U.S.C. 
802(54)(D).
    In order to prevent lapses in care, these exceptions allowed for 
the prescribing of controlled medications via telemedicine encounters 
even when the prescribing practitioner had not conducted an in-person 
medical evaluation of the patient. These telemedicine flexibilities 
authorized practitioners to prescribe schedule II-V controlled 
medications via audio-video telemedicine encounters, including schedule 
III-V narcotic controlled medications approved by the Food and Drug 
Administration (FDA) for maintenance and withdrawal management 
treatment of opioid use disorder via audio-only telemedicine 
encounters, provided that such prescriptions otherwise comply with the 
requirements outlined in DEA guidance documents, DEA regulations, and 
applicable Federal and State law. DEA granted those temporary 
exceptions to the Ryan Haight Act and DEA's implementing regulations 
via two letters published in March 2020:
     A March 25, 2020 ``Dear Registrant'' letter signed by 
William T. McDermott, DEA's then-Assistant Administrator, Diversion 
Control Division (the McDermott Letter); \1\ and
---------------------------------------------------------------------------

    \1\ William T. McDermott, DEA Dear Registrant letter, Drug 
Enforcement Administration (March 25, 2020), https://www.deadiversion.usdoj.gov/GDP/(DEA-DC-
018)(DEA067)%20DEA%20state%20reciprocity%20(final)(Signed).pdf.
---------------------------------------------------------------------------

     A March 31, 2020 ``Dear Registrant'' letter signed by 
Thomas W. Prevoznik, DEA's then-Deputy Assistant

[[Page 91254]]

Administrator, Diversion Control Division (the Prevoznik Letter).\2\
---------------------------------------------------------------------------

    \2\ Thomas W. Prevoznik, DEA Dear Registrant letter, Drug 
Enforcement Administration (March 31, 2020), https://www.deadiversion.usdoj.gov/GDP/(DEA-DC-
022)(DEA068)%20DEA%20SAMHSA%20buprenorphine%20telemedicine%20%20(Fina
l)%20+Esign.pdf.
---------------------------------------------------------------------------

    On March 1, 2023, DEA, in concert with HHS, promulgated two notices 
of proposed rulemaking (NPRMs) in the Federal Register--``Telemedicine 
Prescribing of Controlled Substances When the Practitioner and the 
Patient Have Not Had a Prior In-Person Medical Evaluation'' \3\ (the 
General Telemedicine NPRM) and ``Expansion of Induction of 
Buprenorphine via Telemedicine Encounter'' \4\ (the Buprenorphine 
NPRM)--which proposed to expand patient access to prescriptions for 
controlled medications via telemedicine encounters relative to the pre-
COVID-19 PHE landscape. The purpose of the two proposed rules was to 
make permanent some of the telemedicine flexibilities established 
during the COVID-19 PHE in order to facilitate patient access to 
controlled medications via telemedicine when consistent with public 
health and safety, while maintaining effective controls against 
diversion. The comment period for these two NPRMs closed on March 31, 
2023. Those NPRMs generated a total of 38,369 public comments--35,454 
comments on the General Telemedicine NPRM and 2,915 comments on the 
Buprenorphine NPRM. Many of those comments requested changes of varying 
degrees to the proposed regulations in the two March 2023 NPRMs.
---------------------------------------------------------------------------

    \3\ 88 FR 12875 (Mar. 1, 2023).
    \4\ 88 FR 12890 (Mar. 1, 2023).
---------------------------------------------------------------------------

    On May 10, 2023 DEA, jointly with HHS (with the Substance Abuse and 
Mental Health Services Administration (SAMHSA) acting on behalf of 
HHS), issued the first temporary extension (First Temporary Rule), 
which extended the full set of telemedicine flexibilities regarding the 
prescribing of controlled medications, as had been in place under the 
COVID-19 PHE, through November 11, 2023.\5\ The First Temporary Rule 
also provided a one-year grace period, through November 11, 2024, to 
any practitioner-patient telemedicine relationships that had been or 
would be established on or before November 11, 2023. In other words, 
under the First Temporary Rule, if a patient and a practitioner had 
established a telemedicine relationship on or before November 11, 2023, 
the same telemedicine flexibilities that had governed the relationship 
to that point would continue to apply through November 11, 2024.
---------------------------------------------------------------------------

    \5\ Temporary Extension of COVID-19 Telemedicine Flexibilities 
for Prescription of Controlled Medications, 88 FR 30037 (May 10, 
2023).
---------------------------------------------------------------------------

    On August 7, 2023, DEA announced that it would host Telemedicine 
Listening Sessions on September 12 and 13, 2023, in order to receive 
additional input concerning the practice of telemedicine with regards 
to prescribing controlled medications and potential safeguards that 
could effectively prevent and detect diversion of controlled substances 
prescribed via telemedicine. On October 10, 2023, DEA, jointly with 
HHS, issued a second temporary extension (Second Temporary Rule) 
extending the full set of telemedicine flexibilities regarding 
prescription of controlled medications as were in place during the 
COVID-19 PHE, through December 31, 2024.\6\ This extension authorized 
all DEA-registered practitioners to prescribe schedule II-V controlled 
medications via telemedicine through December 31, 2024, whether or not 
the patient and practitioner established a telemedicine relationship on 
or before November 11, 2023. In other words, the grace period provided 
in the First Temporary Rule was effectively subsumed by this Second 
Temporary Rule, which continued the extension of the current 
flexibilities for all practitioner-patient relationships--not just 
those established on or before November 11, 2023--until the end of 
2024.
---------------------------------------------------------------------------

    \6\ Second Temporary Extension of COVID-19 Telemedicine 
Flexibilities for Prescription of Controlled Medications, 88 FR 
69879 (October 10, 2023).
---------------------------------------------------------------------------

    On June 13 and 27, 2024, DEA held virtual Tribal Consultations with 
numerous Tribal governments and organizations in order to elicit 
further comment from interested Tribal parties regarding the 
prescribing of controlled medications via telemedicine and its impact 
on Tribal persons. Additionally, in June 2024, DEA transmitted a new 
draft telemedicine NPRM to the Office of Management and Budget (OMB) 
for review under Executive Order (E.O.) 12866. Since then, DEA has also 
attended several meetings with interested parties coordinated by OMB 
pursuant to E.O. 12866, which have provided interested parties with the 
opportunity to provide further views to OMB.
    With the deadline of December 31, 2024, granted by the Second 
Temporary Rule quickly approaching, DEA, jointly with HHS, is now 
issuing a third temporary extension (Third Temporary Rule) to ensure a 
smooth transition for patients and practitioners that have come to rely 
on the availability of telemedicine for controlled medication 
prescriptions. This additional time will allow DEA (and also HHS, for 
rules that must be issued jointly) to promulgate proposed and final 
regulations that are consistent with public health and safety, and that 
also effectively mitigate the risk of possible diversion. Furthermore, 
this Third Temporary Rule will allow adequate time for providers to 
come into compliance with any new standards or safeguards eventually 
adopted in a final set of regulations. DEA remains committed to 
carefully evaluating the comments received in response to the prior 
NPRMs, as well as the information and perspectives presented at the 
Telemedicine Listening Sessions, the Tribal Consultations, and the E.O. 
12866 meetings.

II. Legal Authority

    The Ryan Haight Act amended the Controlled Substances Act (CSA) to 
generally require that the dispensing of controlled medications by 
means of the internet be predicated on a valid prescription involving 
at least one in-person medical evaluation.\7\ At the same time, it also 
established excepted categories of telemedicine pursuant to which a 
practitioner may prescribe controlled medications for a patient despite 
never having evaluated that patient in person, provided that, among 
other things, such practice is in accordance with applicable Federal 
and State laws.\8\
---------------------------------------------------------------------------

    \7\ 21 U.S.C. 829(e).
    \8\ 21 U.S.C. 802(54)(A)-(G). The Attorney General has delegated 
his rulemaking authority under this provision to the Administrator 
of DEA via 28 CFR 0.100. The Secretary delegated his rulemaking 
authority under 21 U.S.C. 802(54)(G) to the Assistant Secretary for 
Mental Health and Substance Use within the Substance Abuse and 
Mental Health Services Administration on May 4, 2023.
---------------------------------------------------------------------------

    One of these categories authorizes the Attorney General and the 
Secretary to jointly promulgate rules that would allow practitioners to 
prescribe medications for patients via telemedicine without having had 
an in-person evaluation when such telemedicine practice is in 
accordance with applicable Federal and State laws, uses an approved 
telecommunications system, and is ``conducted under . . . circumstances 
that the[y have] . . . determined to be consistent with effective 
controls against diversion and otherwise consistent with the public 
health and safety.'' \9\
---------------------------------------------------------------------------

    \9\ 21 U.S.C. 802(54)(G).
---------------------------------------------------------------------------

    Pursuant to this authority, DEA, jointly with HHS, is hereby 
promulgating this Third Temporary Rule specifying certain circumstances 
under which practitioners may

[[Page 91255]]

prescribe controlled medications, for the time period described above, 
to patients whom the practitioner has never evaluated in person. This 
Third Temporary Rule, like the First and Second Temporary Rules, covers 
the portions of the March 2023 NPRMs related to extensions of the 
telemedicine flexibilities in place during the COVID-19 PHE, and it 
extends, through December 31, 2025, the telemedicine flexibilities that 
have been in place since March 2020 for prescribing controlled 
medications via the practice of telemedicine.
    As noted previously, DEA and, for rules that must be issued 
jointly, HHS anticipate implementing a final set of regulations that 
are consistent with the public health and safety and that also 
effectively mitigate the risk of possible diversion. However, given the 
impending expiration of the flexibilities provided in the Second 
Temporary Rule and the additional consideration of the input received 
during the Telemedicine Listening Sessions, the Tribal Consultations, 
and the E.O. 12866 meetings, DEA, jointly with HHS, has elected to 
again extend those flexibilities to maintain access to care during a 
limited window of time as the agencies consider the appropriate pathway 
forward.
    As explained further below, because this is an extension of limited 
duration of flexibilities that existed during the COVID-19 PHE, DEA and 
HHS have determined that this Third Temporary Rule is consistent ``with 
effective controls against diversion and otherwise consistent with the 
public health and safety'' as required under 21 U.S.C. 802(54)(G). 
Thus, DEA, jointly with HHS, is promulgating this temporary rule 
pursuant to 21 U.S.C. 802(54)(G).
    HHS has advised DEA that no additional rulemaking by HHS is 
necessary as it pertains to the promulgation of these provisions 
pursuant to 21 U.S.C. 802(54)(G).

III. Purpose and Need for Regulatory Changes

    The purpose of this rulemaking is to further extend, for a limited 
period of time, the telemedicine flexibilities that existed during the 
COVID-19 PHE in order to:
     Prevent a reduction in access to care for patients who do 
not yet have an existing telemedicine relationship with their 
practitioners pending promulgation of a final rule or rules addressing 
telemedicine more generally;
     For relationships established both during the COVID-19 PHE 
and those established during the prior extensions, prevent backlogs 
with respect to in-person medical evaluations in the months shortly 
before and after the expiration of the telemedicine flexibilities and 
ensure the availability of telemedicine for practitioners and patients 
who have come to rely on it;
     Address the urgent public health need for continued access 
to buprenorphine as medication for opioid use disorder in the context 
of the continuing opioid public health crisis;
     Allow patients, practitioners, pharmacists, service 
providers, and other stakeholders sufficient time to prepare for the 
implementation of any future regulations that apply to prescribing of 
controlled medications via telemedicine;
     Enable DEA to continue considering the presentations made 
at the Telemedicine Listening Sessions, the Tribal Consultations, and 
the E.O. 12866 meetings;
     Enable DEA, with HHS for rules that must be issued 
jointly, to conduct a thorough evaluation of regulatory alternatives in 
order to promulgate regulations that most effectively expand access to 
telemedicine encounters in a manner that is consistent with the public 
health and safety, while also effectively mitigating against the risk 
of possible diversion; and
     Avoid incentivizing the investment necessary to develop 
new telemedicine companies that might encourage or enable problematic 
prescribing practices by limiting the third extension of flexibilities 
to a short, time-limited period.

IV. Summary of Third Temporary Rule Changes

    This Third Temporary Rule amends portions of 21 CFR 1307.41 and 42 
CFR 12.1 through December 31, 2025.
    Paragraph (a) is amended to state that the authorization granted in 
the amended paragraph (c) expires at the end of December 31, 2025, 
instead of December 31, 2024.
    Current paragraph (b) is deleted.
    Current paragraph (c) is redesignated as paragraph (b) and is 
amended to reflect that current paragraph (d) has been deleted and to 
extend the COVID-19 telemedicine prescribing flexibilities through 
December 31, 2025, provided all the conditions listed in current 
paragraph (e) are met.
    Current paragraph (d) is deleted.
    Current paragraph (e) is redesignated as paragraph (c) and is 
amended to reflect that current paragraphs (b) and (d) have been 
deleted.
    DEA and HHS are using the revise and republish instruction to 
reflect these changes as parts of newly redesignated paragraph (c) are 
not changing.

V. Regulatory Analyses

Administrative Procedure Act

    DEA and HHS are issuing this rule without prior notice and an 
opportunity to comment pursuant to the Administrative Procedure Act's 
(APA's) ``good cause'' exception. In certain circumstances, agencies 
may forgo notice-and-comment rulemaking when a rulemaking is published 
in the Federal Register and the agency ``for good cause finds . . . 
that notice and public procedure thereon are impracticable, 
unnecessary, or contrary to the public interest.'' \10\
---------------------------------------------------------------------------

    \10\ 5 U.S.C. 553(b)(B).
---------------------------------------------------------------------------

    As discussed earlier, DEA, jointly with HHS, is publishing this 
third temporary extension of certain exceptions to existing DEA 
regulations, granted in March 2020 as a result of the COVID-19 PHE, in 
order to prevent reduced access to care for patients that do not yet 
have an existing telemedicine relationship with their practitioners 
pending promulgation of a final rule or rules addressing telemedicine 
more generally. It would be impracticable for DEA and HHS to publish a 
notice of proposed rulemaking; await, review, and respond to new 
comments; and issue a rule in the time remaining before the second 
extension expires on December 31, 2024. Further, the reduction in 
access to care that patients would experience if the existing 
telemedicine flexibilities ended on December 31, 2024 would be contrary 
to the public interest, as it could lead to potential patient harm--due 
to an inability to access appropriate care--in some instances.
    As noted above, in March 2023, DEA received 38,369 comments on two 
proposed rules regarding the flexibilities that would be extended by 
this rule. DEA considered those comments in publishing the First 
Temporary Rule and Second Temporary Rule.\11\ Moreover, any final rule 
or rules that DEA and, for rules that must be issued jointly, HHS 
promulgate addressing telemedicine more generally would reflect 
viewpoints and information from comments received in response to the 
proposed rules, the Telemedicine Listening Sessions, the Tribal 
Consultations, the E.O. 12866 meetings, and any further comments that 
may be collected during additional rounds of public comment. Because 
DEA and, for rules that must be issued jointly, HHS continue to 
consider information that

[[Page 91256]]

was provided in those comments and presentations, and that may be 
provided in the near future before issuing a final set of regulations, 
further opportunity for public comment on these flexibilities at this 
time would serve little, if any, purpose.
---------------------------------------------------------------------------

    \11\ 88 FR 30037 (May 10, 2023) and 88 FR 69879 (October 10, 
2023).
---------------------------------------------------------------------------

    For these reasons, each of which individually constitutes good 
cause, DEA, jointly with HHS, finds that notice and public comment on 
this rule are impracticable, unnecessary, and contrary to the public 
interest.

Executive Orders 12866 (Regulatory Planning and Review), 13563 
(Improving Regulation and Regulatory Review), and 14094 (Modernizing 
Regulatory Review)

    This Third Temporary Rule was developed in accordance with the 
principles of E.O. 12866, as amended by E.O. 14094 and E.O. 13563. E.O. 
12866 directs agencies to assess all costs and benefits of available 
regulatory alternatives and, if regulation is necessary, to select 
regulatory approaches that maximize net benefits (including potential 
economic, environmental, public health, and safety effects; 
distributive impacts; and equity). E.O. 13563 is supplemental to and 
reaffirms the principles, structures, and definitions governing 
regulatory review established in E.O. 12866.
    The economic, interagency, budgetary, legal, and policy 
implications of this temporary rule have been examined, and DEA has 
determined that it is a significant regulatory action under E.O. 12866, 
but not a Section 3(f)(1) significant regulatory action. Accordingly, 
this rule has been submitted to OMB for review.
    DEA, jointly with HHS, is publishing this Third Temporary Rule to 
further extend certain exceptions DEA granted to its existing 
regulations in March 2020 as a result of the COVID-19 PHE in order to 
avoid a lapse of care for patients. The additional extension of the 
COVID-19 flexibilities until December 31, 2025, is necessary to 
thoroughly consider the presentations made at the Telemedicine 
Listening Sessions, the Tribal Consultations, the E.O. 12866 meetings, 
as well as the comments made to the proposed rules set forth in the 
March 2023 NPRMs.
    Without this Third Temporary Rule, the COVID-19 PHE telemedicine 
flexibilities are scheduled to expire on December 31, 2024. This rule 
extends the expiration of those flexibilities through December 31, 
2025. Because this rule does not create or remove any regulatory 
requirements, DEA and HHS estimate that there is no cost associated 
with this Third Temporary Rule. However, DEA and HHS believe this 
extension creates a benefit in the form of cost savings to prescribers 
and patients and reduced transfer payments to the Federal Government, 
similar to those described in the General Telemedicine NPRM. However, 
DEA is unable to quantify the cost savings and reduction in transfer 
payments.

Executive Order 12988, Civil Justice Reform

    The Third Temporary Rule meets the applicable standards set forth 
in sections 3(a) and 3(b)(2) of E.O. 12988 to eliminate drafting errors 
and ambiguity, minimize litigation, provide a clear legal standard for 
affected conduct, and promote simplification and burden reduction.

Executive Order 13132, Federalism

    This Third Temporary Rule does not have federalism implications 
warranting the application of E.O. 13132. The rule does not have 
substantial direct effects on the States, on the relationship between 
the national government and the States, or the distribution of power 
and responsibilities among the various levels of government.

Executive Order 13175, Consultation and Coordination With Indian Tribal 
Governments

    This Third Temporary Rule does not have substantial direct effects 
on the Tribes, on the relationship between the national government and 
the Tribes, or the distribution of power and responsibilities between 
the Federal Government and Indian Tribes. However, DEA has determined 
that there is a reasonable basis that the March 2023 NPRMs may have 
Tribal implications, consistent with the definition in E.O. 13175. As 
such, DEA engaged in virtual consultations with numerous Tribal 
governments and organizations on June 13 and 27, 2024. DEA plans to 
incorporate the concerns raised during those virtual consultations when 
a final set of regulations is promulgated.

Regulatory Flexibility Act

    The Administrator, in accordance with the Regulatory Flexibility 
Act (5 U.S.C. 601-612) (RFA), has reviewed this Third Temporary Rule 
and by approving it certifies that it will not have a significant 
economic impact on a substantial number of small entities. This Third 
Temporary Rule, as discussed above, merely extends for a limited time 
the status quo with respect to the current flexibilities allowed during 
the COVID-19 PHE, in order to avoid lapses in coverage for patients.
    Without this Third Temporary Rule, the COVID-19 PHE telemedicine 
flexibilities would expire on December 31, 2024. While this Third 
Temporary Rule does not create or remove any regulatory requirements, 
this Third Temporary Rule extends the expiration of those flexibilities 
through December 31, 2025. DEA and HHS believe this extension creates a 
benefit in the form of cost savings to prescribers and patients and 
reduced transfer payments to the Federal Government.
    In accordance with the RFA, DEA will be evaluating the impact on 
small entities at the time the final rule or rules are issued as part 
of these rulemakings.

Unfunded Mandates Reform Act of 1995

    The estimated annual impact of this rule is minimal. Thus, DEA has 
determined in accordance with the Unfunded Mandates Reform Act of 1995 
(UMRA) (2 U.S.C. 1501 et seq.) that this action would not result in any 
federal mandate that may result in the expenditure by State, local, and 
tribal governments, in the aggregate, or by the private sector, of 
$100,000,000 or more (adjusted for inflation) in any one year. 
Therefore, neither a Small Government Agency Plan nor any other action 
is required under provisions of UMRA.

Congressional Review Act

    This temporary rule is not a major rule as defined by Subtitle E of 
the Small Business Regulatory Enforcement Fairness Act of 1996 (known 
as the Congressional Review Act or CRA).\12\ However, pursuant to the 
CRA, DEA is submitting a copy of this temporary rule to both Houses of 
Congress and to the Comptroller General.
---------------------------------------------------------------------------

    \12\ 5 U.S.C. 804(2).
---------------------------------------------------------------------------

Paperwork Reduction Act of 1995

    This temporary rule will not impose a new collection or modify an 
existing collection of information under the Paperwork Reduction Act of 
1995 (44 U.S.C. 3501-3521). Also, this temporary rule does not impose 
recordkeeping or reporting requirements on State or local governments, 
individuals, businesses, or other organizations. An agency may not 
conduct or sponsor, and a person is not required to respond to, a 
collection of information unless it displays a valid OMB control 
number.

[[Page 91257]]

List of Subjects

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1307

    Administrative practice and procedure, Drug traffic control, 
Prescription drugs.

DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 12

    Administrative practice and procedure, Drug traffic control, 
Prescription drugs.

Drug Enforcement Administration

    For the reasons set out above, the Drug Enforcement Administration 
amends 21 CFR part 1307 as follows:

PART 1307--MISCELLANEOUS

0
1. The authority citation for part 1307 continues to read as follows:

    Authority: 21 U.S.C. 821, 822(d), 871(b), unless otherwise 
noted.

0
2. Revise and republish Sec.  1307.41 to read as follows:

Sec.  1307.41  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, 
2025. The authorization granted in paragraph (b) of this section 
expires at the end of December 31, 2025.
    (b) During the period May 12, 2023, through December 31, 2025, 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 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.

DEPARTMENT OF HEALTH AND HUMAN SERVICES

    For the reasons set out above, the Department of Health and Human 
Services amends 42 CFR part 12 as follows:

PART 12--TELEMEDICINE FLEXIBILITIES

0
1. The authority citation for part 12 continues to read as follows:

    Authority:  21 U.S.C. 802(54)(G).

0
2. Revise and republish Sec.  12.1 to read as follows:

Sec.  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, 
2025. The authorization granted in paragraph (b) of this section 
expires at the end of December 31, 2025.
    (b) During the period May 12, 2023, through December 31, 2025, 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.

Signing Authority

    This document of the Drug Enforcement Administration and the 
Department of Health and Human Services was signed on November 14, 
2024, by DEA Administrator Anne Milgram and the HHS Assistant Secretary 
for Mental Health and Substance Use. Those documents with the original 
signatures and dates are maintained by DEA. For administrative purposes 
only, and in compliance with requirements of the Office of the Federal 
Register, the undersigned DEA Federal Register Liaison Officer has been 
authorized to sign and submit the document in electronic format for 
publication, as an official document of DEA. This administrative 
process in no way alters the legal effect of this document upon 
publication in the Federal Register.

Heather Achbach,
Federal Register Liaison Officer, Drug Enforcement Administration.
Miriam E. Delphin-Rittmon,
Assistant Secretary for Mental Health and Substance Use, Department of 
Health and Human Services.
[FR Doc. 2024-27018 Filed 11-15-24; 4:15 pm]
BILLING CODE 4410-09-P
```