6504 Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Rules and Regulations 

1The Attorney General has delegated this 

authority to the Administrator of DEA under 28 

CFR 0.100. 

2 88 FR 12890 (Mar. 1, 2023). 

3Treatment of OUD means the use of effective 

FDA-approved medications including methadone, 

buprenorphine, and naltrexone to treat opioid use 

disorder. See NIDA. 2021, December 2. Overview. 

https://nida.nih.gov/publications/research-reports/ 

medications-to-treat-opioid-addiction/overview. 

Last accessed on January 8, 2025. 

4 DEA understands there are situations where the 

patient (for whom the prescription was written) 

may not be the individual picking up the 

prescription at the pharmacy. In these situations, 

DEA defers to the definition of ‘‘ultimate user’’ as 

found in 21 U.S.C. 802(27). As such, this regulation 

authorizes the pharmacist to verify the identity of 

the patient by accepting identification from any 

individual who falls under the definition of 

‘‘ultimate user’’ prior to filling a prescription. 

5 ‘‘Dispense’’ in the context of this rulemaking 

means to deliver a controlled substance to an 

ultimate user, which includes the prescribing of a 

controlled substance. 21 U.S.C 802(10). 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

21 CFR Part 1306 

[Docket No. DEA–948] 

RIN 1117–AB78 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

42 CFR Part 12 

Expansion of Buprenorphine 

Treatment via Telemedicine Encounter 

AGENCY: Drug Enforcement 

Administration, Department of Justice; 

Substance Abuse and Mental Health 

Services Administration, Department of 

Health and Human Services. 

ACTION: Final rule. 

SUMMARY: The Drug Enforcement 

Administration and the Department of 

Health and Human Services are 

amending their regulations to expand 

the circumstances under which 

practitioners registered by the Drug 

Enforcement Administration are 

authorized to prescribe schedule III–V 

controlled substances approved by the 

Food and Drug Administration for the 

treatment of opioid use disorder via a 

telemedicine encounter, including an 

audio-only telemedicine encounter. 

Under these new regulations, after a 

practitioner reviews the patient’s 

prescription drug monitoring program 

data for the state in which the patient 

is located during the telemedicine 

encounter, the practitioner may 

prescribe an initial six-month supply of 

such medications (split amongst several 

prescriptions totaling six calendar 

months) through audio-only means. 

Additional prescriptions can be issued 

under other forms of telemedicine as 

authorized under the Controlled 

Substances Act, or after an in-person 

medical evaluation is conducted. This 

regulation also requires the pharmacist 

to verify the identity of the patient prior 

to filling a prescription. The Ryan 

Haight Online Pharmacy Consumer 

Protection Act of 2008 generally 

requires an in-person medical 

evaluation prior to issuance of a 

controlled substance prescription. 

However, this regulation falls under one 

of the exceptions found within the Ryan 

Haight Act. Additionally, this regulation 

does not affect practitioner-patient 

relationships in cases where an inperson medical evaluation has 

previously occurred. The purpose of 

this regulation is to prevent lapses of 

care by continuing some of the 

telemedicine flexibilities that currently 

exist for those patients seeking 

treatment for opioid use disorder. 

DATES: This rule is effective February 

18, 2025. 

FOR FURTHER INFORMATION CONTACT: 

Heather E. Achbach, Regulatory Drafting 

and Policy Support Section, Diversion 

Control Division, Drug Enforcement 

Administration; Telephone: (571) 776– 

3882. 

SUPPLEMENTARY INFORMATION: 

I. Executive Summary 

This final rule falls under the last 

category of telemedicine under the Ryan 

Haight Act, Public Law 110–425, 122 

Stat. 4820 (2008), which authorizes the 

practice of telemedicine in specified 

circumstances when no in-person 

medical evaluation has occurred. The 

Administrator of the Drug Enforcement 

Administration (DEA) (pursuant to 

delegation by the Attorney General) 1

and the Substance Abuse and Mental 

Health Services Administration (on 

behalf of the Secretary of Health and 

Human Services (HHS) jointly issue this 

regulation and have each determined 

that this regulation is consistent with 

effective controls against diversion and 

with the public health and safety as 

required under 21 U.S.C. 802(54)(G). 

In March 2023, DEA published a 

notice of proposed rulemaking (NPRM) 

titled Expansion of Induction of 

Buprenorphine via Telemedicine 

Encounter.2 DEA and HHS are now 

finalizing the rule, with several 

modifications to the proposed 

provisions to address concerns brought 

forth by commenters. Under this final 

rule, a DEA-registered practitioner, prior 

to issuing a prescription via 

telemedicine for a schedule III–V 

controlled substance approved by the 

Food and Drug Administration (FDA) 

for use in the treatment of opioid use 

disorder (OUD),3 must review the 

prescription drug monitoring program 

(PDMP) data of the state in which the 

patient is located when the telemedicine 

encounter occurs, and the pharmacist 

must verify the identity of the patient 4

prior to filling the prescription. The 

practitioner is authorized to prescribe 

up to an initial six-month supply (split 

amongst several prescriptions totaling 

six calendar months); additional 

prescriptions may be issued under other 

forms of telemedicine as authorized by 

the Controlled Substances Act (CSA) or 

after an in-person medical evaluation is 

conducted. 

This final rule pertains to 

practitioners prescribing controlled 

substances to patients for the treatment 

of OUD in circumstances where the 

prescribing practitioner has not 

conducted an in-person medical 

evaluation of the patient prior to the 

issuance of the prescription. Therefore, 

it is important to emphasize that the 

limitations set forth in this final rule, 

and those associated with the ‘‘practice 

of telemedicine’’ as defined in 21 U.S.C. 

802(54) generally, do not apply to 

practitioner-patient relationships in 

which there has already been a prior inperson medical evaluation of the patient 

by the prescribing practitioner. 

II. Legal Authority and Background 

DEA implements and enforces the 

Comprehensive Drug Abuse Prevention 

and Control Act of 1970, often referred 

to as the CSA, and the Controlled 

Substances Import and Export Act, (21 

U.S.C. 801–971), as amended. DEA 

publishes the implementing regulations 

for these statutes in 21 CFR parts 1300 

through 1399. These regulations are 

designed to ensure a sufficient supply of 

controlled substances for medical, 

scientific, and other legitimate 

purposes, and to deter the diversion of 

controlled substances for illicit 

purposes. 

As mandated by the CSA, DEA 

establishes and maintains a closed 

system of control for manufacturing, 

distribution, and dispensing of 

controlled substances, and requires any 

person who manufactures, distributes, 

dispenses, imports, exports, or conducts 

research or chemical analysis with 

controlled substances to register with 

DEA, unless they meet an exemption, 

pursuant to 21 U.S.C. 822.5 The CSA 

further authorizes the Attorney General 

(and the Administrator of DEA by 

delegation through 28 CFR part 0) to 

promulgate regulations necessary and 

appropriate to execute the functions of 


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Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Rules and Regulations 6505 

6 21 U.S.C. 871(b), 958(f). 

7 21 U.S.C. 829(e)(1). 

8 Id. 829(e)(2)(A)(i). 

9 Id. 829(e)(3)(A). 

10 42 U.S.C. 1395m(m) references, but does not 

define, such telecommunications systems. The 

Center for Medicare and Medicaid Services (CMS) 

promulgated regulations implementing these 

statutory provisions and define the term interactive 

telecommunications system. 42 CFR 410.78(a)(3) 

defines interactive telecommunications system as 

the multimedia communications equipment that 

includes, at a minimum, audio and video 

equipment permitting two-way, real-time 

interactive communication between the patient and 

distant site physician or practitioner. Interactive 

telecommunications system may also include twoway, real-time audio-only communication 

technology for any telehealth service furnished to 

a patient in their home if the distant site physician 

or practitioner is technically capable of using an 

interactive telecommunications system as defined 

in the previous sentence, but the patient is not 

capable of, or does not consent to, the use of video 

technology. 

11 21 U.S.C. 802(54). 

12See 21 U.S.C. 802(54). 

13 Id. 802(54)(G). 

14 42 CFR 410.78(a)(3). 

15 Determination That a Public Health Emergency 

Exists, U.S. Department of Health and Human 

Services. https://aspr.hhs.gov/legal/PHE/Pages/ 

2019-nCoV.aspx. Last accessed May 1, 2024. 

16William T. McDermott, DEA Dear Registrant 

letter, Drug Enforcement Administration (Mar. 25, 

2020), https://www.deadiversion.usdoj.gov/GDP/ 

(DEA-DC-018)(DEA067)%20DEA%20state%20

reciprocity%20(final)(Signed).pdf. 

17Thomas W. Prevoznik, DEA Dear Registrant 

letter, Drug Enforcement Administration (Mar. 31, 

2020), https://www.deadiversion.usdoj.gov/GDP/ 

(DEA-DC-022)(DEA068)%20DEA%20SAMHSA

%20buprenorphine%20telemedicine%20%20

(Final)%20+Esign.pdf. 

18Temporary Extension of COVID–19 

Telemedicine Flexibilities for Prescription of 

Controlled Medications, 88 FR 30037 (May 10, 

2023). 

subchapter I (Control and Enforcement) 

and subchapter II (Import and Export) of 

the CSA.6

The Ryan Haight Act 

The Ryan Haight Online Pharmacy 

Consumer Protection Act of 2008 (Ryan 

Haight Act) amended the CSA, in part, 

by adding several new provisions to 

prevent the illegal distribution and 

dispensing of controlled substances by 

means of the internet. The Ryan Haight 

Act generally requires that a practitioner 

conduct an in-person medical 

evaluation before issuing a prescription 

to a patient. This requirement is set 

forth in 21 U.S.C. 829(e), which 

provides that ‘‘[n]o controlled substance 

that is a prescription drug as determined 

under the Federal Food, Drug, and 

Cosmetic Act may be . . . dispensed by 

means of the internet without a valid 

prescription.’’ 7 A ‘‘valid prescription’’ 

is defined as ‘‘a prescription that is 

issued for a legitimate medical purpose 

in the usual course of professional 

practice by . . . a practitioner who has 

conducted at least 1 in-person medical 

evaluation of the patient.’’ 8 Section 

829(e) further provides an exception to 

the in-person medical evaluation when 

a practitioner is ‘‘engaged in practice of 

telemedicine.’’ 9 The practice of 

telemedicine is defined as ‘‘the practice 

of medicine in accordance with 

applicable Federal and state laws by a 

practitioner (other than a pharmacist) 

who is at a location remote from the 

patient and is communicating with the 

patient, or health care professional who 

is treating the patient, using a 

telecommunications system 10 referred 

to in section 1395m(m) of Title 42.’’ 11

The Ryan Haight Act sets forth seven 

distinct categories in which a 

prescribing practitioner may engage in 

the practice of telemedicine even 

though no in-person medical evaluation 

has been conducted.12 In these 

circumstances, provided certain 

safeguards are in place to ensure that 

the practitioner who is engaged in the 

practice of telemedicine is able to 

conduct a bona fide medical evaluation 

of the patient at the remote location, and 

is otherwise acting in the usual course 

of professional practice, the Ryan 

Haight Act contemplates that the 

practitioner will be permitted to 

prescribe controlled substances via 

telemedicine encounters despite not 

having conducted an in-person medical 

evaluation prior to prescribing. 

Specifically, the last category provides 

that a telemedicine encounter may 

occur between the practitioner and the 

patient ‘‘under any other circumstances 

that the Attorney General and the 

Secretary [of Health and Human 

Services] have jointly, by regulation, 

determined to be consistent with 

effective controls against diversion and 

otherwise consistent with the public 

health and safety.’’ 13

As noted above, when practitioners 

engage in the practice of telemedicine, 

the practitioner must use ‘‘a 

telecommunications system referred to 

in section 1395m(m) of Title 42.’’ For 

purposes of section 1395m(m), the 

Centers for Medicare and Medicaid 

Services (CMS) has defined ‘‘interactive 

telecommunications system’’ as 

multimedia communications equipment 

that includes, at a minimum, audio and 

video equipment permitting two-way, 

real-time interactive communication 

between the patient and distant site 

physician or practitioner. Interactive 

telecommunications system may also 

include two-way, real-time audio-only 

communication technology for any 

telehealth service furnished to a patient 

in their home if the distant site 

physician or practitioner is technically 

capable of using an interactive 

telecommunications system as defined 

in the previous sentence, but the patient 

is not capable of, or does not consent to, 

the use of video technology.14 DEA and 

HHS are utilizing the aforementioned 

definition of ‘‘interactive 

telecommunications system’’ within this 

final rule. 

COVID–19 Public Health Emergency 

In response to the COVID–19 Public 

Health Emergency (PHE), as declared by 

the Secretary of HHS on January 31, 

2020, pursuant to the authority under 

section 319 of the Public Health Service 

Act (42 U.S.C. 247),15 DEA granted 

temporary exceptions to the Ryan 

Haight Act and DEA’s implementing 

regulations under 21 U.S.C. 802(54)(D), 

one of the seven distinct categories of 

telemedicine envisioned under the 

statutory definition of the practice of 

telemedicine. In order to prevent lapses 

in care, these exceptions authorized the 

prescribing of controlled-substance 

medications via telemedicine 

encounters even when the prescribing 

practitioner had not conducted an inperson medical evaluation of the 

patient. These telemedicine flexibilities 

authorized practitioners to prescribe 

schedule II–V controlled substances via 

audio-video telemedicine encounters, 

including schedule III–V controlled 

substances approved by the FDA for the 

treatment of OUD via audio-only 

telemedicine encounters. DEA granted 

the 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); 16 and 

• A March 31, 2020 ‘‘Dear Registrant’’ 

letter signed by Thomas W. Prevoznik, 

DEA’s then-Deputy Assistant 

Administrator, Diversion Control 

Division (the Prevoznik Letter).17

Temporary Rules and Telemedicine 

Listening Sessions 

On May 10, 2023 DEA, jointly with 

HHS (with the Substance Abuse and 

Mental Health Services Administration 

(SAMHSA) acting on behalf of HHS), 

issued a temporary extension (First 

Temporary Rule) pursuant to 21 U.S.C. 

802(54)(G), which extended the full set 

of telemedicine flexibilities regarding 

the prescribing of controlled substances 

that had been in place under the 

COVID–19 PHE, through November 11, 

2023.18 On September 12 and 13, 2023, 


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6506 Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Rules and Regulations 

19Second Temporary Extension of COVID–19 

Telemedicine Flexibilities for Prescription of 

Controlled Medications, 88 FR 69879 (Oct. 10, 

2023). 20Third Temporary Extension of COVID–19 

Telemedicine Flexibilities for Prescription of 

Controlled Medications, 89 FR 91253 (Nov. 19, 

2024). 21 42 CFR 8.12(h)(2)(ii). 22See 21 U.S.C. 812(b)(3)(A)–(C); 21 CFR 

1308.13(e)(2)(i). 

23Buprenorphine, Substance Abuse and Mental 

Health Services Administration. https://

www.samhsa.gov/medications-substance-usedisorders/medications-counseling-relatedconditions/buprenorphine. Last accessed Apr. 11, 

2024. 

24 Id. 

25 Id. 

26Provisional Drug Overdose Death Counts, 

National Center for Health Statistics, Centers for 

Disease Control and Prevention. https://

www.cdc.gov/nchs/nvss/vsrr/drug-overdosedata.htm. Updated Mar. 3, 2024. Last accessed Apr. 

12, 2024. 

27Opioid-Related Outcomes Among Individuals 

With Co-occurring Behavioral Health Conditions, 

National Quality Forum Final Report. https://

www.qualityforum.org/Publications/2022/09/2022_

Opioid_and_Behavioral_Health_Final_Report.aspx. 

Published September 26, 2022. Last accessed Apr. 

12, 2024. See also ‘Fourth wave’ of opioid epidemic 

crashes ashore, propelled by fentanyl and meth, 

Washington State Standard. https://

washingtonstatestandard.com/2024/03/18/fourthwave-of-opioid-epidemic-crashes-ashore-propelledby-fentanyl-and-meth/. Published March 18, 2024. 

Last accessed Apr. 12, 2024. 

28Ciccarone, D, The Rise of Illicit Fentanyls, 

Stimulants and the Fourth Wave of the Opioid 

Overdose Crisis, Curr Opin Psychiatry (July 1, 

2021), The Rise of Illicit Fentanyls, Stimulants and 

the Fourth Wave of the Opioid Overdose Crisis— 

PMC. Last accessed Oct. 28, 2024. 

29 37 FR 37986; see also 21 CFR 1306.07(a). 

30Title XXXV of Public Law 106–310. DATA was 

subsequently amended in 2005 (Pub. L. 109–56), 

2016 (sec. 303 of Title III of the Comprehensive 

Addiction and Recovery Act of 2016, Pub. L. 114– 

198) and in 2018 (sec. 3202 of the Substance UseDisorder Prevention That Promotes Opioid 

Recovery and Treatment for Patients and 

Communities Act, Pub. L. 115–271). 

31Section 1262 of Public Law 117–328. 

32 Id. 

DEA hosted live, in-person 

Telemedicine Listening Sessions, to 

receive additional input concerning the 

practice of telemedicine, namely, the 

advisability of permitting telemedicine 

prescribing of certain controlled 

substances without any in-person 

medical evaluation. Approximately 58 

stakeholders, including DEA-registered 

institutional and individual 

practitioners, pharmacists, trade 

associations, state agencies, and other 

public interest groups, presented at the 

listening sessions. On October 10, 2023, 

DEA, jointly with HHS, issued a second 

temporary extension (Second 

Temporary Rule), also pursuant to 21 

U.S.C. 802(54)(G), thereby extending the 

full set of telemedicine flexibilities 

regarding prescription of controlled 

substances as were in place during the 

COVID–19 PHE through December 31, 

2024.19 This extension authorized all 

DEA-registered practitioners to 

prescribe schedule II–V controlled 

substances via telemedicine through 

December 31, 2024. On November 19, 

2024, DEA, jointly with HHS, issued a 

third temporary extension (Third 

Temporary Rule) extending the current 

telemedicine flexibilities that have been 

in place since March 2020 through 

December 31, 2025.20

III. The Opioid Overdose Epidemic and 

Buprenorphine Use in Treating Opioid 

Use Disorder 

One way to assist individuals 

experiencing acute opioid withdrawal 

symptoms and seeking treatment for 

OUD is with the administration of 

certain narcotic controlled substances. 

The use of medications approved by the 

FDA for the treatment of OUD can 

effectively assist an individual in 

successfully recovering from opioid 

dependence. Currently, the only 

schedule III–V controlled substance 

narcotic drug approved by the FDA for 

the treatment of OUD is 

buprenorphine.21

DEA classifies buprenorphine as a 

schedule III narcotic controlled 

substance because it has a currently 

accepted medical use in treatment, and 

has less potential for misuse than 

controlled substances in schedules I and 

II under the CSA.22 Buprenorphine is a 

long-acting partial opioid agonist. Its 

effects last for a longer period of time 

compared to a short-acting 

medication.23 For people who are not 

used to taking opioids, it can cause 

effects such as euphoria or respiratory 

depression, but these effects are weaker, 

and with less risk, including lower risk 

of overdose, than those caused by full 

opioid agonists such as heroin or 

fentanyl.24 When buprenorphine is 

taken as prescribed and at the 

appropriate dosage, it can significantly 

diminish cravings, lower physical 

dependence on other opioids, eliminate 

withdrawal symptoms, and reduce 

morbidity and cases of death from 

overdose.25 Buprenorphine is an 

effective medication for treating OUD, 

especially when used as part of a 

complete, individualized, treatment 

plan. 

However, because buprenorphine is 

itself an opioid, it can be misused or 

abused, and it should be used under the 

care of a practitioner to decrease the 

likelihood of diversion. As explained 

below, this final rule will expand access 

to OUD treatments by authorizing DEAregistered practitioners with schedule 

III–V authority the ability to prescribe 

schedule III–V controlled substances 

approved by the FDA for the treatment 

of OUD via audio-only telemedicine 

encounter, while also mitigating the 

risks of diversion. 

A. The Opioid Overdose Epidemic and 

Treatments 

The estimated number of deaths from 

opioid overdoses for the 12-month 

period ending in October 2023 was 

79,695, with a peak of 83,985 opioid 

overdose deaths in the 12-month period 

ending in May 2023.26 Although the 

opioid overdose epidemic has plagued 

the United States for many decades, 

overdose deaths have been attributed to 

‘‘several distinct waves’’ beginning in 

the late 1990s with expanded opioid 

analgesic prescribing for pain; another 

wave following in 2010 involving 

heroin; and a third wave began in 2013 

related to illicit fentanyl, primarily 

illicitly made fentanyl 27 The United 

States is currently experiencing a fourth 

wave related to rising polysubstance use 

and co-involvement of fentanyl and 

stimulant drugs such as 

methamphetamine.28

To combat substance abuse and assist 

individuals in receiving proper 

treatment, DEA published regulations in 

October 1974 to implement the Narcotic 

Addict Treatment Act of 1974 (NATA), 

authorizing practitioners to administer 

and dispense certain narcotic controlled 

substances, like methadone (schedule II) 

for detoxification treatment or 

maintenance treatment as long as the 

practitioners were separately registered 

as a narcotic treatment program (NTP or 

Opioid Treatment Program (OTP) as 

termed by SAMHSA).29 The Drug 

Addiction Treatment Act of 2000 

(DATA) further expanded treatment 

options for OUD by authorizing 

physicians who met certain 

qualifications to treat OUD with FDAapproved medications, like 

buprenorphine, in treatment settings 

other than NTPs/OTPs.30 These DEAregistered practitioners became known 

as ‘‘DATA-waived practitioners.’’ Most 

recently, the Consolidated 

Appropriations Act, 2023 (CAA, 23) 

(Pub. L. 117–328) removed the DATAwaiver requirement, expanding 

practitioner ability to prescribe 

buprenorphine.31 Under the CAA, DEAregistered practitioners with the 

authority to prescribe schedule III 

controlled substances can prescribe 

buprenorphine to their patients without 

needing a DATA waiver or having a 

limit or cap as to the number of patients 

they can treat.32


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33 Dadiomov, et al., Buprenorphine and naloxone 

access in pharmacies within high overdose areas of 

Los Angeles during the COVID–19 pandemic, Harm 

Reduction Journal (June 29, 2022). https://

harmreductionjournal.biomedcentral.com/articles/ 

10.1186/s12954-022-00651-3. Last accessed Apr. 11, 

2024. 

34Larochelle, et al., Medication for Opioid Use 

Disorder After Nonfatal Opioid Overdose and 

Association With Mortality, Annals of Internal 

Medicine (Aug. 7, 2018), https://

www.acpjournals.org/doi/10.7326/M17-3107. Last 

accessed Apr. 11, 2024. 

35Only one in Four People Needing Treatment for 

Opioid Use Disorder Received Medication, 

Columbia University School of Public Health (Mar. 

23, 2022), https://www.publichealth.columbia.edu/ 

public-health-now/news/only-one-four-peopleneeding-treatment-opioid-use-disorder-receivedmedication. Last accessed Apr. 11, 2024. 

36Telemedicine Listening Sessions, Dr. Juan 

Hincapie-Castillo (National Pain Advocacy Center), 

173:7–13 (Sept. 13, 2023) (available: https://

www.deadiversion.usdoj.gov/Telemedicine_

listening_session.html). 

37 DeLaCruz et al., Telemental Health for the 

Homeless Population: Lessons Learned when 

Leveraging Care (December 8, 2022), https://

www.ncbi.nlm.nih.gov/pmc/articles/PMC9734763/. 

38Telemedicine Listening Sessions, Daniel Reck 

(Matclinics), 104:3–9 (Sept. 12, 2023). 

39Suboxone is a medication containing 

buprenorphine, and is a schedule III controlled 

substance. Buprenorphine, SAMHSA.gov, https://

www.samhsa.gov/medications-substance-usedisorders/medications-counseling-relatedconditions/buprenorphine. Last accessed Apr. 20, 

2024. 

40Telemedicine Listening Sessions, Jerome 

Cohan (Catalyst Health Solutions), 268:2–20 (Sept. 

12, 2023). 

41 88 FR 12890 (Mar. 1, 2023). 

42For the purposes of this rule, reference to 

treatment of OUD via telemedicine encounters 

refers to all stages of treatment of OUD, including 

‘‘maintenance treatment’’ and ‘‘detoxification 

treatment’’ as defined under 21 U.S.C. 802(29)–(30). 

B. Barriers To Access and Risk of 

Diversion of Buprenorphine 

Access to buprenorphine decreases 

the risk of opioid-related overdose.33

Increasing access to buprenorphine after 

a drug overdose has also been associated 

with a reduced risk of death.34 However, 

barriers to access remain. One study 

showed that of those Americans who 

likely would benefit from treatment for 

OUD, only 28% actually received such 

treatment.35 Another impediment 

occurs at pharmacies where pharmacists 

decline to fill buprenorphine 

prescriptions. For example, during the 

Telemedicine Listening Sessions, one 

speaker stated that pharmacies have 

sometimes declined to fill telemedicine 

prescriptions for buprenorphine, which 

they may perceive as inferior or suspect 

solely because the prescription was 

issued through telemedicine.36

Expanding the circumstances under 

which practitioners are authorized to 

prescribe buprenorphine via 

telemedicine encounters, including 

audio-only encounters, would increase 

access to treatment for those individuals 

with OUD who may not want to seek 

treatment, or are unable to seek 

treatment, due to various economic, 

geographical, sociological, and logistical 

reasons. Many patients may lack the 

financial means to obtain in-person 

treatment traditionally or through 

audio-video telemedicine encounters. 

Patients who are unhoused, 

unemployed, or facing other challenges 

may find it prohibitive to afford devices 

capable of audio-video telemedicine 

encounters or to find consistent access 

to wireless internet and/or data plans 

adequate to support bandwidth 

demands of audio-video telemedicine 

encounters.37

This final rule authorizing audio-only 

telemedicine of buprenorphine in 

certain circumstances does not imply 

that buprenorphine cannot be, or is not, 

diverted. Some presenters spoke to 

these issues during the Telemedicine 

Listening Sessions. According to one 

presentation, there is a ‘‘robust illicit 

market for buprenorphine,’’ and patients 

may be selling buprenorphine to fund 

abuse of other controlled substances.38

Another presenter said that drugs that 

contain Suboxone®, which contains 

buprenorphine 39 prescribed to treat 

OUD, can be used as a ‘‘currency’’ to 

purchase other drugs like 

methamphetamine, adding that, in the 

individual’s community, ‘‘if [abuse or 

misuse of] methamphetamine is 

involved, you can pretty much be 

assured the diversion of buprenorphine 

is involved.’’ 40

Though, as with all transactions 

involving controlled substances, there is 

an inherent risk of diversion, DEA and 

HHS believe these regulatory provisions 

have been narrowly tailored to enable 

DEA and HHS to mitigate the risk of 

diversion associated with 

buprenorphine prescriptions issued 

pursuant to these new regulations. 

Moreover, considering the efficacy of 

treating OUD with buprenorphine when 

taken appropriately and subject to the 

additional safeguards in this rule, DEA 

and HHS believe that expanding access 

to buprenorphine through audio-only 

telemedicine outweighs the relatively 

lower risk of misuse and diversion of 

buprenorphine. 

IV. Summary of Notice of Proposed 

Rulemaking 

DEA published an NPRM titled 

Expansion of Induction of 

Buprenorphine via Telemedicine 

Encounter, jointly with HHS, on March 

1, 2023.41 Within this NPRM, DEA and 

HHS proposed adding definitions for 

‘‘prescription drug monitoring program’’ 

and ‘‘telemedicine encounter.’’ This 

NPRM proposed to authorize 

practitioners to prescribe buprenorphine 

for maintenance treatment and 

detoxification treatment 42 of OUD via 

telemedicine encounter, to include an 

audio-only telemedicine encounter, if 

all of the following certain conditions 

were met: (1) the practitioner would 

have needed to be registered under 21 

U.S.C. 823(g), see 21 CFR 

1301.13(e)(1)(iv), in the state in which 

the practitioner was located; (2) the 

practitioner would have needed to be 

authorized by state law to engage in the 

practice of telemedicine in both the 

state where the practitioner is located 

and the patient is located; (3) the 

practitioner would have needed to be 

authorized under 21 CFR 1301.28; and 

(4) the practitioner would have needed 

to be technologically capable of 

conducting a telemedicine encounter by 

using audio and video equipment. Prior 

to prescribing, the practitioner would 

have been required to review and 

consider the PDMP data of the state in 

which the patient is located regarding 

any controlled substance prescriptions 

issued to the patient in the last year, or 

if less than one year’s worth of PDMP 

data was available, the entire available 

period. 

The practitioner would have been 

required to review the PDMP data 

within seven days of the telemedicine 

encounter and would then have been 

authorized to prescribe an initial 30-day 

supply of schedule III–V 

buprenorphine-containing medication 

until a subsequent in-person medical 

evaluation of the patient had been 

conducted. Specifically, in order to 

prescribe more than a 30-day supply, 

the practitioner would have had three 

options as to how to conduct that 

subsequent in-person medical 

evaluation: (1) an in-person medical 

evaluation in which the patient would 

be in the physical presence of the 

prescribing practitioner; (2) an in-person 

medical evaluation in which the patient 

would be in the physical presence of a 

DEA-registered practitioner (other than 

the prescribing practitioner) and the two 

practitioners and patient were 

participating in a simultaneous realtime audio-video conference 

(‘‘Telepresenter’’ Model); or (3) an inperson medical evaluation would be 

conducted by a DEA-registered 

practitioner who then issued a written 

‘‘qualifying telemedicine referral’’ for 

the patient to a prescribing practitioner 

before sharing an electronic medical 

record for the patient with the 

prescribing practitioner. Ultimately, 


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43 21 CFR 1306.51(b)(4). 

44 88 FR 12875 (Mar. 1, 2023). 

under any of these three pathways, the 

patient would have been required to be 

in the physical presence of a DEAregistered practitioner at some point to 

receive more than a 30-day supply of 

medication. Furthermore, additional 

recordkeeping requirements would have 

been mandatory if the medical 

evaluation occurred in the presence of 

another DEA-registered practitioner or 

through a qualifying telemedicine 

referral. For example, the prescribing 

practitioner would have been required 

to record whether the encounter was 

conducted via audio-video or audioonly means and record the reason a 

patient chose an audio-only 

telemedicine encounter when 

applicable. The NPRM also would have 

required practitioners to maintain 

copies of all qualifying telemedicine 

referrals, if the referral pathway had 

been used to conduct the subsequent inperson medical evaluation. If the 

practitioner was unable to access the 

required PDMP data, the practitioner 

would have been authorized to issue a 

seven-day buprenorphine prescription 

and would have been required to record 

both the dates and times of any attempts 

to access the PDMP data, as well as why 

the practitioner was unable to access the 

PDMP data. 

V. Summary of Changes From the 

NPRM 

After reviewing comments received in 

response to the NPRM, as will be 

discussed in more detail below, DEA 

and HHS have amended the 

requirements for this rulemaking. Most 

significantly, DEA and HHS have 

expanded the initial 30-day prescription 

supply limitation via audio-only 

telemedicine to a six calendar month 

supply limitation. In addition, DEA is 

no longer amending 21 CFR part 1300 

relating to definitions and part 1304 

relating to records and reports of 

registrants. Specifically, DEA and HHS 

are no longer defining the terms 

‘‘prescription drug monitoring program’’ 

or ‘‘telemedicine encounter’’ that were 

found in the NPRM. DEA and HHS have 

also removed the requirement that in 

order to prescribe more than the initial 

supply of buprenorphine, an in-person 

medical evaluation of some sort must be 

conducted. In other words, DEA and 

HHS have removed the three options 

through which a subsequent in-person 

medical evaluation may be conducted 

and specified instead that continued 

prescribing may occur pursuant to other 

forms of the practice of telemedicine as 

defined in 21 U.S.C. 802(54). 

In drafting the NPRM, DEA and HHS 

sought to ensure that patient access to 

buprenorphine via telemedicine 

encounters, including audio-only 

telemedicine encounters, would still be 

authorized to continue once the COVID 

flexibilities ended, but also included 

additional requirements, not found 

within the flexibilities, to ensure that 

effective controls are in place to combat 

diversion. To this end, DEA and HHS 

created a framework under which 

specific types of in-person medical 

evaluations would have been required 

to be conducted after the initial 30-day 

prescription. However, a review of the 

comments persuaded DEA and HHS that 

the requirements found within the 

NPRM would be overly burdensome for 

the majority of patients, contradicting 

an important goal of this rulemaking. 

Therefore, in its place, DEA and HHS 

have expanded the 30-day supply 

limitation to an initial six-month 

prescription supply limitation, after 

which two options can be used by the 

practitioner in order to continue 

prescribing to the patient: (1) conduct 

an in-person medical evaluation as 

defined in 21 U.S.C. 829(e)(2)(B); or (2) 

continue treating the patient via another 

form of telemedicine as defined in 21 

U.S.C. 802(54). Since the supply 

limitation has been increased and a 

patient will not necessarily need to be 

seen in-person by the prescribing 

practitioner at any point, DEA and HHS 

have included an identification 

verification requirement, wherein the 

pharmacist must verify a patient’s 

identity prior to filling a prescription 

issued under these regulations. 

Additionally, pursuant to this final 

rule, the practitioner will be required to 

review the PDMP data of the state in 

which the patient is located when the 

telemedicine evaluation occurred, prior 

to issuing a prescription. The 

practitioner will also be required to 

annotate the date and time that the 

PDMP was reviewed. If the PDMP is 

unavailable or inaccessible for any 

reason, the practitioner will be required 

to notate the date and time that such 

review was attempted and will be 

authorized to prescribe renewable 

seven-day prescriptions until the sixmonth limitation is reached; attempts 

must be made to review the PDMP every 

seven days in this situation. The 

remaining recordkeeping requirements 

from the NPRM, including maintaining 

a record of whether the encounter was 

conducted via audio-visual or audioonly means, why the patient chose an 

audio-only telemedicine encounter, and 

maintaining copies of all qualifying 

telemedicine referrals, have not been 

promulgated within the final rule. 

Lastly, DEA and HHS invited 

comments for any additional safeguards 

or flexibilities that should be considered 

with respect to the proposed regulatory 

changes. Based on comments received 

in response, and as noted above and 

discussed in more detail below, DEA 

and HHS are promulgating an additional 

provision which would require 

pharmacists to verify the identification 

of the patient receiving the prescription 

under this framework prior to 

dispensing the controlled substance 

medication.43

VI. Discussion of Public Comments 

Received 

DEA and HHS received a total of 

2,915 comments in response to the 

NPRM. Of those comments, 68 were 

intended for the separately published 

NPRM titled Telemedicine Prescribing 

of Controlled Substances When the 

Practitioner and the Patient Have Not 

Had a Prior In-Person Medical 

Evaluation 44 and 178 were deemed 

outside the scope of the proposed 

rulemaking. As such, those comments 

will not be discussed further within this 

rulemaking. DEA and HHS received 

comments from practitioners, 

pharmacists, lawyers, professional 

associations, government entities, Tribal 

nations and associations, law firms and 

law school clinics, private companies, 

medical organizations, hospitals and 

medical practices, pharmacies, 

educational institutions, health 

insurance companies, and other 

members of the general public. DEA and 

HHS thank all commenters for their 

input during the rulemaking process. 

All comments have been reviewed. 

DEA and HHS have grouped the 

comments into several distinct 

categories below in order to more easily 

summarize and respond to the large 

number of comments received in 

response to the NPRM. Of the comments 

received, some comments pertained to 

only one issue while others involved 

several issues. 

In-Person Medical Examination 

Requirement 

Comment: DEA and HHS received the 

largest number of comments pertaining 

to the NPRM’s proposed in-person 

medical evaluation requirement 

following the initial 30-day supply. 

Commenters raised several issues and 

concerns with this requirement. The 

following is a summary of the comments 

received. One thousand two hundred 

and eighty (1,280) commenters 

expressed concern that the proposed inperson medical evaluation requirement 

would be costly and/or time-prohibitive 

to patients. Commenters stated that the 


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45 K. Moulaei et al., Patients’ perspectives and 

preferences toward telemedicine versus in-person 

visits: a mixed-methods study on 1226 patients 

(Nov. 15, 2023). https://www.ncbi.nlm.nih.gov/ 

pmc/articles/PMC10647122/#:∼:text=

The%20primary%20reasons%20for

%20selecting,better%20treatment%20of%20the

%20disease. Last accessed Aug. 5, 2024. 

46 Id. 

in-person medical evaluation 

requirement created obstacles, such as: 

living in a rural area, work 

responsibilities or an inability to take 

leave from work, family and childcare 

obligations, and transportation issues. 

Three hundred and fifty-nine (359) 

commenters stated that the in-person 

medical evaluation requirement would 

result in a lack of care or reduced access 

to care because the in-person medical 

evaluation requirement would be a 

barrier to treatment. These commenters 

stated that patients may drop out of 

their treatment program and potentially 

relapse due to the in-person medical 

evaluation requirement potentially 

limiting access to buprenorphine via 

remote care. Two hundred and thirty 

(230) commenters stated that there still 

remains stigma within their community 

regarding OUD treatment and requiring 

patients to be seen in-person could 

expose them to harm, ‘‘out them’’ to the 

general public, and/or reduce their 

ability to keep their treatment private. 

Two hundred and seventeen (217) 

commenters expressed concern about a 

physical or mental hardship or risk 

potentially limiting their ability to fulfill 

an in-person medical evaluation 

requirement; these included mental 

health conditions such as agoraphobia, 

physical conditions, other conditions 

such as autism, and/or wanting to avoid 

interactions with other patients 

receiving OUD treatment out of concern 

that such interactions could increase the 

likelihood of a relapse. One hundred 

and twenty one (121) commenters stated 

that an evaluation conducted in-person 

is generally the same as one conducted 

via a virtual appointment and there is 

no separate benefit in receiving a 

medical evaluation in-person for 

purposes of OUD treatment. Sixty nine 

(69) commenters stated that an inperson medical evaluation requirement 

would have a disparate impact on or 

discriminate against certain persons, 

including those with disabilities, 

persons of color, American Indians/ 

Alaska Natives, the elderly, and those 

recently incarcerated. 

Sixty seven (67) commenters stated 

that an in-person medical evaluation 

would be nearly impossible for them to 

schedule because of a general 

practitioner shortage and 44 

commenters expressed the same 

concern because of a buprenorphine 

practitioner shortage within their 

geographic area. Fifty three (53) 

commenters, many of whom identified 

themselves as practitioners, stated that 

the decision to conduct or not conduct 

an in-person examination constitutes a 

clinical decision that should be left to 

the practitioner’s discretion and 

therefore, there should be no in-person 

medical evaluation requirement 

imposed by regulation. Twenty two (22) 

commenters stated that in-person 

medical evaluations are rarely utilized 

for those receiving OUD treatment. One 

commenter stated that the Ryan Haight 

Act does not require an in-person 

medical evaluation, and if an in-person 

medical evaluation is required under 

the Ryan Haight Act, the in-person 

medical evaluation can be conducted by 

the prescribing practitioner or a practice 

group. Nine hundred and eleven (911) 

commenters expressed general 

disapproval of the in-person medical 

evaluation requirement. 

Response: DEA and HHS understand 

the many hardships an in-person 

medical evaluation requirement could 

cause patients and notes the multitude 

of reasons provided by commenters as 

to why this requirement would be 

burdensome to many patients. 

Therefore, DEA and HHS have 

expanded the initial prescription supply 

that may occur pursuant to audio-only 

telemedicine encounters from 30 days to 

six months. In addition, DEA and HHS 

have promulgated this final rule offering 

two options pursuant to which the 

prescribing practitioner is authorized to 

issue additional prescriptions for the 

treatment of OUD via telemedicine 

encounters subsequent to this initial sixmonth supply: (1) the practitioner can 

conduct an in-person medical 

evaluation; or (2) the practitioner can 

engage in other forms of the practice of 

telemedicine as defined in 21 U.S.C. 

802(54). DEA and HHS believe this 

solution, which will allow subsequent 

prescribing pursuant to additional 

telemedicine pathways as DEA (and for 

rules that must be issued jointly, HHS) 

promulgate regulations permitting them, 

likely will further alleviate the various 

concerns raised by commenters as to the 

options for continued treatment. 

Comment: DEA and HHS received 11 

comments agreeing with the inclusion 

of the in-person medical evaluation 

requirement. These commenters stated 

that the requirement is important 

because in-person medical evaluations 

prior to buprenorphine induction allow 

a practitioner to better determine the 

state of the patient and ensure the 

patient is not under the influence of any 

other substances. 

Response: DEA and HHS agree that an 

in-person medical evaluation provides a 

prescribing practitioner with valuable 

information about the patient that might 

not be fully discerned via a 

telemedicine encounter. The in-person 

medical evaluation allows a prescribing 

practitioner to conduct a thorough 

physical assessment of the patient, more 

accurately assess the patient’s physical 

and mental health, and provides more 

accurate treatment options.45

Additionally, DEA and HHS believe an 

in-person medical evaluation can serve 

as an effective control against diversion 

by allowing the practitioner to better 

discern whether the medications the 

patient has been prescribed are working 

effectively and are being taken 

appropriately by the patient.46 However, 

DEA and HHS understand that not all 

patients are able to schedule and attend 

an in-person medical evaluation. As 

mentioned above, given the unique 

circumstances of increasing access to 

potentially life-saving medications for 

the treatment of OUD during the 

overdose epidemic, DEA and HHS 

believe that removing the in-person 

medical evaluation requirement is 

appropriate in this situation. Therefore, 

within this final rule, DEA and HHS 

have provided the option for the 

practitioner to conduct an in-person 

medical evaluation; otherwise, 

practitioners are able to continue 

prescribing via other forms of 

telemedicine authorized under the CSA 

after the initial six-month prescription. 

In-Person Medical Evaluation 

Requirement Alternatives 

Comment: DEA and HHS received 144 

total comments regarding the nontraditional methods of fulfilling the inperson medical evaluation 

requirement,’’ i.e., the Telepresenter 

Model or the qualifying telemedicine 

referral, listed within the NPRM. Seven 

comments addressed the Telepresenter 

Model, i.e., a scenario in which the 

patient attends an in-person medical 

evaluation in the physical presence of a 

DEA-registered practitioner (other than 

the prescribing practitioner) and the two 

practitioners and patient participate in a 

simultaneous real-time audio-video 

conference; 137 comments addressed 

the qualifying telemedicine referral 

model. For the Telepresenter Model, 

commenters expressed concern that this 

model also requires a substantial 

amount of travel (especially if the 

patient resides in a rural area); that it 

would be extremely difficult for the 

patient to try to coordinate the 

schedules of two practitioners; that 

these consults would be cumbersome 


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and unmanageable; that this model is 

not common practice in this type of 

medical care; and that getting an inperson appointment would be difficult 

especially for those who face stigma 

within their community for receiving 

OUD treatment. With regards to the 

qualifying telemedicine referral, the 

commenters stated that the referral 

process would be overly cumbersome 

and unnecessary; some practitioners 

may refuse to conduct an in-person 

medical evaluation for the purpose of 

issuing a referral; it takes too long to get 

a referral; some patients don’t have 

medical insurance and requiring an inperson medical evaluation and a referral 

would not be possible; it is hard to make 

an in-person appointment with a 

primary care physician (PCP) as many 

people don’t have PCPs; if a patient 

needs care from an addiction specialist 

the patient would need to wait for the 

referral before beginning treatment; and 

the referral process would be a barrier 

and diminish success of the treatment 

program. 

Response: DEA and HHS 

acknowledge that these non-traditional 

methods for fulfilling the in-person 

medical evaluation requirement may not 

represent feasible options for many 

patients. As noted above, DEA and HHS 

have removed both the Telepresenter 

Model and the qualifying telemedicine 

referral process from the final rule. DEA 

and HHS agree that, for many patients, 

these proposed provisions were not 

practicable and would create an undue 

burden on both patients and 

practitioners. After the initial six-month 

period, the option to conduct a 

traditional in-person medical evaluation 

remains should the practitioner and 

patient wish to continue treatment in 

such a manner. 

30-Day Prescription Supply Limitation 

Comment: DEA and HHS received 

many comments related to the 30-day 

time period limitation. The comments 

asserting that 30 days was too short a 

time period in which to obtain an inperson medical evaluation are 

summarized in the above sections 

relating to in-person medical 

evaluations. DEA and HHS received a 

total of 68 comments related specifically 

to the 30-day prescription supply 

limitation. Some commenters stated that 

30 days was too short a duration for 

buprenorphine dispensing before an inperson medical evaluation could be 

obtained, while other commenters 

generally supported the 30-day supply 

limitation. The commenters who 

believed 30 days was not enough time 

cited to various reasons: 10 commenters 

believed that the 30-day supply 

limitation was arbitrary and that it is not 

the typical length of prescription 

provided for OUD treatment; three 

commenters stated that 30 days 

represents insufficient supply and will 

interrupt a treatment regimen that has 

already been established; and one 

commenter stated the limit should be 

removed if the patient is clinically 

indicated for a buprenorphine 

prescription. 41 commenters stated 

there should be a prescription limitation 

but requested that the time period be 

increased from 30 days. Five 

commenters stated the supply limitation 

should be removed and prescriptions 

should be issued indefinitely; while two 

commenters stated that the prescribing 

practitioner should decide how long a 

prescription should be issued for. 

Four commenters expressed support 

for the 30-day supply limitation and 

indicated that 30 days was an 

appropriate time period. One of these 

commenters (a patient) stated they 

currently receive a 30-day supply of 

buprenorphine at a time and had no 

concerns with that limit. Two 

commenters indicated a 30-day supply 

prior to an in-person medical evaluation 

was too permissive: one commenter 

stated that after the initial 30-day 

supply, refills should only occur seven 

days at a time until an in-person 

medical evaluation could be obtained; 

and the other commenter stated that 

prescriptions should be restricted to 

three-to-seven days for new patients 

with documentation that an in-person 

medical evaluation was not practical 

with one three-to-seven-day refill 

prescribed by a fully trained addiction 

physician. Additionally, some of these 

commenters asked clarifying questions 

about whether the 30-day supply 

limitation was only for a buprenorphine 

initiation period and not for every 30- 

day period of buprenorphine treatment, 

and also requested clarification about 

how the proposed regulations would 

have addressed a patient who started 

with a 30-day supply and then was ‘‘lost 

to follow-up’’ but later re-engaged with 

treatment. 

Response: DEA and HHS 

acknowledge the commenters’ concerns 

and agree that 30 days is too short of a 

timeframe to receive an initial 

buprenorphine prescription before being 

required to obtain an in-person medical 

evaluation to receive additional 

prescriptions. After reviewing the 

comments and feedback from the 

various listening sessions, DEA and 

HHS agree that many patients would 

have difficulty in scheduling an inperson medical evaluation with a 

practitioner and/or specialist within a 

30-day time period. At the same time 

however, DEA and HHS believe that 

prescriptions issued pursuant to audioonly telemedicine should not be issued 

indefinitely or solely at the discretion of 

the practitioner, given the increased 

risks of abuse, misuse, or other forms of 

diversion posed by audio-only 

telemedicine without a visual or inperson component. Several commenters 

suggested 180 days (six months) as a 

supply limitation before an in-person 

medical evaluation should be 

conducted. DEA and HHS agree and 

believe a six-month supply provides 

adequate time for a patient to be 

stabilized on medication via audio-only 

medical encounter(s) without unduly 

increasing the risk of diversion. 

Therefore, the final rule allows for an 

initial prescription limitation of six 

calendar months after which time either 

an in-person medical evaluation must 

be conducted or the practitioner can 

continue prescribing via another form of 

telemedicine. DEA is also clarifying that 

the six-month (previously 30-day) 

supply limitation applies when the 

patient is treated by the same 

practitioner, regardless of when the sixmonth prescriptions are issued. For 

example, if a patient receives a 

prescription for a one-month supply 

three times by a practitioner, then stops 

treatment with that practitioner, the 

patient can only receive prescriptions 

for another three months of supply upon 

resuming treatment with that same 

practitioner, regardless of the reason 

treatment was stopped and time period 

that treatment was paused. Once an inperson medical evaluation has been 

conducted, the practitioner and patient 

are no longer engaged in the practice of 

telemedicine under 21 U.S.C. 802(54) 

and are thus no longer bound to the 

requirements found within this rule. 

Mandatory PDMP Review 

Comment: DEA received 30 comments 

opposing the mandatory PDMP review 

prior to issuing a buprenorphine 

prescription under this framework. 

These commenters, many of whom 

identified themselves as practitioners or 

as part of professional medical 

associations, stated that PDMP checks 

do not provide valuable information 

because they only show prescribed 

medications, not substances bought on 

the street illegally; state PDMPs do not 

all require practitioners to report the 

same medications (as which 

medications must be reported is based 

on state law); telehealth appointments 

are already limited in duration and 

valuable time would be spent by the 

practitioner reviewing the PDMP; DEA 

should defer to state law as to whether 

a PDMP check is required; patients 


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47F. Alogaili et al., Prescription drug monitoring 

programs in the US: A systematic literature review 

on its strengths and weakness, Journal of Infection 

and Public Health (Sept. 30, 2020). https://

www.sciencedirect.com/science/article/pii/ 

S1876034120305657?via%3Dihub. Last accessed 

Aug. 5, 2024. 

should not be penalized and limited to 

a seven-day supply if the PDMP is 

inaccessible or inoperable; practitioners 

may not have access to a state’s PDMP; 

and the recordkeeping requirement 

associated with the PDMP review is too 

burdensome. Conversely, 15 

commenters agreed with the PDMP 

requirement. 

Response: DEA and HHS believe it is 

essential for a practitioner to review the 

PDMP data for possible drug 

interactions and to discern whether 

there is any potential misuse or abuse of 

prescribed medications within a 

patient’s history. PDMP reviews have 

been shown to combat the fraudulent 

prescribing of medications, reduce 

incidences of multiple overlapping 

prescriptions for the same controlled 

medications, known as doctor shopping, 

aid in the monitoring of controlled 

substance abuse and misuse, and help 

reduce drug-poisoning deaths.47 For 

these reasons, this final rule requires 

practitioners to review PDMP data prior 

to prescribing buprenorphine and 

restricts prescriptions to seven days at a 

time when the PDMP cannot be 

accessed. A review of PDMP laws and 

regulations of the 50 states, along with 

the District of Columbia, Guam, Puerto 

Rico, and the Northern Mariana Islands, 

shows that at least four states require a 

review of PDMP data prior to issuing 

any prescriptions and at least three 

states require the PDMP to be reviewed 

prior to issuing any telemedicine 

prescriptions. Further, 54 states/ 

territories require that buprenorphine 

prescriptions be reported to a PDMP and 

48 states/territories require review of a 

patient’s PDMP data prior to issuing a 

buprenorphine prescription. Since most 

states/territories already have PDMP 

requirements, DEA and HHS believe 

this requirement poses a minimal 

administrative burden on practitioners, 

which are significantly outweighed by 

the benefits of reviewing this data. 

As for recordkeeping requirements, 

this final rule will require practitioners 

to review the PDMP data and notate the 

date and time that such a review took 

place within the patient’s electronic 

health record (EHR) or paper record. 

This notation will ensure that the 

prescribing practitioner has reviewed, or 

attempted to review, the PDMP prior to 

a prescription being issued. DEA and 

HHS understand that many EHR 

systems already contain this capability 

as this information is automatically 

integrated into the patient’s record as 

soon as the data has been reviewed by 

the prescribing practitioner. If the PDMP 

data is inaccessible for any reason, the 

prescribing practitioner will be required 

to notate the date and time that such 

review was attempted, indicate why the 

PDMP was inaccessible, and will be 

limited to prescribing a seven-day 

supply. This seven-day supply can be 

renewed (up to six calendar months) if, 

every time the prescribing practitioner 

tries to review the PDMP data, the 

PDMP system is inoperable. While this 

is not meant to penalize either the 

practitioner or the patient, it should be 

a rare occurrence for a PDMP to be 

inaccessible for a full six-month time 

period. DEA and HHS believe the 

benefits of requiring a practitioner to 

review the patient’s data for signs of 

abuse or misuse of controlled 

substances as soon as it becomes 

available outweigh any potential 

‘‘harms’’ to the patient should the 

patient only receive an initial seven-day 

supply, especially since this seven-day 

supply can be renewed for up to six 

months. 

Recordkeeping Requirements 

Comment: DEA and HHS received 105 

comments voicing disapproval and eight 

comments supporting the recordkeeping 

requirements found within the NPRM. 

Specifically, 75 commenters stated the 

requirements were administratively 

burdensome, time consuming, and 

confusing; would cause delays in 

workflow and patient care; practitioners 

should not need to record why audioonly telemedicine was chosen; the NPI 

and registration number of practitioners 

should not be required to be recorded; 

and practitioners were uncomfortable 

recording their home or physical 

address. 

Twenty four (24) comments pertained 

to the requirement that the practitioner 

maintain a record that the encounter 

was conducted via audio-visual or 

audio-only means. Commenters 

indicated that this requirement would 

exacerbate the already common 

occurrence of pharmacies refusing to fill 

telemedicine prescriptions; there would 

be no clinical value; and it would create 

confusion. Six commenters asked for a 

12-month grace period in order to 

update EHR systems to comply with the 

requirements. 

Response: DEA and HHS agree with 

the commenters who raised concern 

with the stated recordkeeping 

requirements and does not believe the 

requirements would fulfill their 

intended purpose. The majority of the 

recordkeeping requirements detailed 

within the NPRM therefore have been 

removed and the final rule contains 

only one recordkeeping requirement 

that pertains to the PDMP review 

(explained in the previous comment 

response). DEA and HHS believe the 

other safeguards found within this final 

rule will help to prevent diversion 

without being overly burdensome for 

either patients or practitioners. The 

prescribing practitioner will need to 

notate the date and time the PDMP 

review was conducted or, if such review 

could not be completed, the date and 

time the PDMP review was attempted 

and why the review could not be 

completed. As many EHR systems 

already have this functionality 

integrated within their systems, DEA 

and HHS do not believe additional time 

needs to be allocated in order to update 

systems or bring them into compliance 

with this requirement. 

Diversion of Buprenorphine 

Comment: DEA and HHS received 791 

comments regarding diversion of 

buprenorphine. Five hundred and 

twenty (520) commenters stated that the 

proposed rule would result in an 

increase of drug poisonings or overdoses 

due to patients having limited access to 

or losing access to their current 

buprenorphine treatment. One hundred 

and thirty five (135) commenters stated 

that there is no evidence to show that 

telemedicine care leads to higher 

diversion of buprenorphine than inperson care and cited to studies 

concluding that the COVID–19 PHE 

flexibilities did not lead to higher 

diversion or misuse of buprenorphine. 

The remainder of the comments stated 

that if legitimate prescriptions were 

easier to obtain there would be less 

diversion; if buprenorphine is diverted, 

then it is diverted for therapeutic 

purposes or to mitigate withdrawal; the 

buprenorphine combination product 

with naloxone (Suboxone®) actually 

deters diversion and is harder to 

overdose on when misused because of 

its chemical makeup; and increasing 

access to buprenorphine should 

outweigh any potential harm from 

diversion. Twelve (12) commenters 

voiced approval for the rule and stated 

that diversion and overdoses of 

buprenorphine are of real concern and 

there is further cause for concern 

because for-profit telehealth companies 

or ‘‘virtual pill mills’’ have been 

expanding their buprenorphine 

business, which could lead to more 

diversion of the medication. 

Response: DEA and HHS understand 

that the COVID–19 PHE flexibilities 

have allowed for greater access to 

buprenorphine and it is DEA and HHS’s 


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48The CSA requires all practitioners to be 

registered in the state in which the patients to 

which they are prescribing controlled substances 

are located, regardless of whether the prescribing is 

taking place via telemedicine. The CSA provides 

that every person who dispenses, or who proposes 

to dispense, any controlled substance shall obtain 

from DEA a registration issued in accordance with 

DEA rules and regulations. See 21 U.S.C. 822(a)(2). 

Under the CSA, such dispensing includes 

prescribing and administering controlled 

substances. Id. 802(10). DEA may only register a 

person to dispense a controlled substance if that 

person is permitted to do so by the jurisdiction in 

which his or her patients are located. See id. 

802(21), 823(f). Thus, unless an applicable 

exception applies, DEA regulations require a 

practitioner to obtain a separate DEA registration in 

each state in which a patient to whom he or she 

prescribes a controlled substance is located when 

the prescription is made, regardless of whether the 

prescription is made via telemedicine. The CSA 

also contains provisions (added by the Ryan Haight 

Act) expressly requiring a practitioner to be 

registered in the state in which the patient to whom 

he is prescribing is located when he or she is 

intention to continue expanding access 

to buprenorphine via telemedicine for 

patients who have a legitimate need for 

treatment as the flexibilities come to an 

end. DEA and HHS have relaxed many 

of the requirements found within the 

NPRM, in response to concerns raised 

by commenters that patients may have 

limited access or lose access to 

treatment otherwise. 

However, DEA has a mandate and 

commitment to detect and prevent the 

diversion of controlled substances, 

regardless of the reason for diversion, so 

DEA and HHS must nevertheless place 

certain safeguards on the telemedicine 

prescribing of buprenorphine. DEA and 

HHS note that several commenters 

expressed concern over buprenorphine 

diversion and the growth of ‘‘virtual pill 

mill’’ companies during the time the 

COVID–19 PHE flexibilities have been 

in place. Determining the reasons for 

diversion of buprenorphine in any 

particular case may prove difficult to 

discern, and a patient may divert 

buprenorphine for both claimed 

therapeutic and non-therapeutic 

purposes. Specifically, and as noted 

above, buprenorphine constitutes an 

effective treatment for OUD, but it can 

also create euphoric feelings similar in 

kind—even if not in intensity—to other 

opioid agonists. For these reasons, it is 

possible that some diverted 

buprenorphine might be used for 

reasons other than therapeutic purposes 

or mitigation of withdrawal. As the 

practice of telemedicine facilitates 

wider access to buprenorphine, DEA 

must ensure certain safeguards remain 

in place to deter potential diversion— 

whether for claimed therapeutic or nontherapeutic uses. 

DEA and HHS have promulgated this 

final rule taking into consideration the 

many concerns raised by the thousands 

of comments received in response to the 

NPRM. DEA and HHS have amended 

the requirements from the NPRM to the 

final rule in large part in response to the 

comments and concerns expressed by 

the public, and the data they have 

provided. The safeguards that are found 

within the final rule will continue to 

expand access to OUD treatment by 

allowing for buprenorphine treatment 

via audio-only encounters and will 

allow patients and practitioners to 

continue using telemedicine as a means 

of receiving treatment. The telemedicine 

flexibilities established during the 

COVID–19 PHE were intended to be 

temporary flexibilities during a time 

when in-person care was not universally 

routinely and safely available. The 

COVID–19 PHE flexibilities should not 

continue indefinitely at a time when 

receiving in-person care no longer poses 

a significant risk to public health and 

safety. This final rule acknowledges that 

telemedicine encounters are more 

flexible and convenient to many 

patients but also acknowledges that 

safeguards need to be in place to 

prevent misuse and abuse of controlled 

substances, especially during a time 

when an increasing number of for-profit 

telehealth companies continue to grow 

their practices without any permanent 

regulatory requirements or safeguards. 

Additional Safeguards Requested by 

Commenters 

Comment: DEA and HHS received 41 

comments requesting additional 

regulatory safeguards be put in place on 

top of the requirements already laid out 

in the NPRM. Commenters suggested 

requiring urine drug screens or blood 

tests, monthly pill counts, testing for 

alcohol use, psychological and physical 

monitoring, psychosocial support, and/ 

or follow-up in-person medical 

evaluations every three months for the 

first year of treatment. Some 

commenters were in favor of 

buprenorphine prescribing via 

telehealth only if an in-person medical 

evaluation and drug screen were 

required while others believed that even 

with an in-person medical evaluation 

and drug screen, buprenorphine should 

not be prescribed via telehealth 

encounter. 

Response: DEA and HHS 

acknowledge these concerns. As noted 

above the detection and prevention of 

diversion of buprenorphine is a 

significant priority of this rulemaking. 

At the same time, DEA and HHS 

understand that the addition of too 

many regulatory requirements may 

cause some patients to abandon their 

current OUD treatment or to decline to 

enter treatment in the first place. Within 

this rulemaking, DEA and HHS are 

attempting to continue to expand 

treatment options for OUD and make 

permanent some of the flexibilities 

permitted during the COVID–19 PHE. 

DEA and HHS are confident that the 

safeguards in place within this final rule 

will help alleviate diversion concerns 

while also allowing for patients to seek 

and obtain safe treatment for OUD. 

Additionally, as noted above, 

practitioners who have conducted an inperson medical evaluation of a patient 

are not required to adhere to the 

telemedicine requirements established 

by the Ryan-Haight Act when 

prescribing a controlled substance to 

that patient. More generally, those 

practitioner-patient relationships no 

longer constitute telemedicine as 

defined by the Ryan Haight Act and are 

outside the scope of this rulemaking. 

DEA 823(g) Registration of Practitioners 

Comment: DEA and HHS received 18 

comments regarding DEA registrations 

under 21 U.S.C. 823(g). Three 

commenters stated that a practitioner 

should only need one DEA registration 

and be legally authorized to practice 

telemedicine in the state in which the 

patient is located. Six commenters 

stated that the practitioner should only 

need to be DEA-registered and fully 

licensed in the state in which the 

patient is located. Two commenters 

stated that a practitioner should be able 

to prescribe controlled substances via 

telemedicine as long as they are 

licensed to practice medicine in the 

state the patient is located and that, 

furthermore, the practitioner should not 

also need a DEA registration for the state 

the patient is located in. Four 

commenters stated it was unclear if the 

NPRM was requiring that a practitioner 

needs a DEA registration in both the 

state in which the practitioner is located 

and state in which the patient is located. 

One commenter agreed generally with 

the NPRM and stated that telemedicine 

companies should be required to have a 

DEA registration in every state they 

want to prescribe. Two commenters 

requested an exception for separate DEA 

registrations for practitioners that have 

medical licensing reciprocity 

requirements. 

Response: DEA and HHS understand 

some confusion may have arisen from 

the NPRM regarding registration. As 

DEA has made clear elsewhere, under 

current statutes and regulations, 

practitioners are required, unless subject 

to an exception, to obtain a DEA 

registration both in the state in which 

the practitioner dispenses controlled 

substances and in the state in which the 

patient is located.48


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engaged in certain forms of telemedicine. Under the 

CSA, a prescription for a controlled substance 

issued by means of the internet must generally be 

predicated on an in-person medical evaluation. See 

id. 829(e)(1). This requirement does not apply, 

however, when a practitioner is practicing 

telemedicine as defined by the CSA. 49See 21 U.S.C. 802(54). 

Definitions 

Comment: DEA and HHS received 14 

comments relating to definitions found 

within the NPRM. Seven commenters 

requested a definition of ‘‘mental health 

disorders’’ be included in the rule; two 

commenters requested removal of the 

‘‘prognosis’’ of OUD requirement as it 

relates to the qualifying telemedicine 

referral; two commenters requested a 

definition for ‘‘telemedicine 

prescription’’; two commenters 

requested amending the definition of 

‘‘patient’s location’’; and one 

commenter stated that DEA should not 

rely on the CMS definition of 

‘‘interactive telecommunications 

system.’’ 

Response: DEA and HHS have greatly 

simplified the final rule, which includes 

omitting any changes to current 

definitions within the Code of Federal 

Regulations. Additionally, as certain 

requirements from the NPRM have been 

removed, such as the qualifying 

telemedicine referral and the need for a 

notation on the telemedicine 

prescription, there is no need to provide 

definitions for those terms. DEA and 

HHS do not believe a definition for 

‘‘mental health disorders’’ is needed as 

that question falls outside the scope of 

this rule. Furthermore, HHS regulations 

define the terms ‘‘drug abuse’’ and 

‘‘drug addiction’’ in 42 CFR 34.2(h) and 

(i) as ‘‘current substance use disorder or 

substance-induced disorder, mild’’ and 

‘‘current substance use disorder or 

substance-induced disorder, moderate 

to severe’’, respectively, using the most 

recent edition of the Diagnostic and 

Statistical Manual for Mental Disorders. 

This rule authorizes the treatment of 

OUD through audio-only means solely 

to treat substance use disorders under 

this definition. The final rule also does 

not enact any regulations that explicitly 

require the ‘‘patient’s location’’ to be 

disclosed, so no definition is needed. 

While DEA and HHS anticipate that 

many of these audio-only encounters 

will occur in a private setting, such as 

a patient’s home, this rule is not placing 

any additional regulations or 

requirements upon the practitioner or 

the patient to verify the patient’s 

location. DEA and HHS will continue to 

rely on the CMS definition of 

‘‘interactive telecommunications 

system’’ within this rule, as the current 

definition of the term ‘‘practice of 

telemedicine’’ uses the CMS 

definition.49

Rule’s Applicability to Pharmacists 

Comment: DEA and HHS received 

seven comments related to the rule’s 

applicability to pharmacists. Four 

commenters requested clarification as to 

whether DEA-registered pharmacists 

who are granted controlled substance 

prescriptive authority within their state 

would be allowed to prescribe and 

dispense medications under this rule, 

and whether they could conduct the inperson medical evaluation (or serve as 

the referring provider) under the 

framework proposed in the NPRM. 

Additionally, three commenters were 

concerned that the rulemaking would 

require pharmacists to ‘‘police’’ the 

practice of telemedicine, placing an 

undue burden on pharmacists and 

overwhelming pharmacy operations. 

These commenters expressed concern 

and sought clarity as to if, and how, a 

pharmacist would be required to verify 

that the in-person medical evaluation 

requirement had been fulfilled; how a 

pharmacist would discern which 

prescriptions are telemedicine 

prescriptions absent an indicator on the 

face of the prescription denoting it as 

such; and how a pharmacist would 

access or receive this information 

without violating the Health Insurance 

Portability and Accountability Act 

(HIPAA) and other patient privacy laws. 

Response: DEA and HHS understand 

the important role pharmacists play 

when they fill controlled substance 

prescriptions and appreciates the 

legitimate concerns raised by these 

comments. DEA and HHS are aware 

there still remains stigma associated 

with OUD treatment and has decided 

not to require a notation on the face of 

the prescription denoting that the 

prescription is one issued via 

telemedicine. DEA and HHS understand 

this may place more responsibility on a 

pharmacist and urges pharmacists to 

treat all buprenorphine prescriptions 

equally, while continuing to fulfill their 

longstanding corresponding 

responsibilities, without attempting to 

discern whether the prescription was 

issued via a telemedicine encounter. 

Pharmacists will not be required to 

access a patient’s record to figure out 

whether the in-person medical 

evaluation has been conducted or 

whether an evaluation was completed 

via telemedicine. This rule is not 

intended to place pharmacists in the 

role of ‘‘policing’’ the practice of 

telemedicine, but rather reflects that 

pharmacists play an integral role in 

helping to prevent drug misuse. As set 

forth in 21 CFR 1306.04(a), ‘‘The 

responsibility for the proper prescribing 

and dispensing of controlled substances 

is upon the prescribing practitioner, but 

a corresponding responsibility rests 

with the pharmacist who fills the 

prescription.’’ Therefore, the pharmacist 

will be required to verify the identity of 

the patient prior to filling a prescription. 

As explained in further detail below, 

many states already have placed on 

pharmacists an identification 

verification requirement for many 

controlled substances, including 

buprenorphine, as a matter of state law, 

and DEA and HHS believe placing an 

identity verification responsibility on 

pharmacists as a matter of Federal law 

generally should not represent an 

additional burden in the vast majority of 

cases. 

Effective Date 

Comment: DEA and HHS received 43 

comments solely concerned with the 

potential effective date of the final rule. 

Twenty (20) comments requested that 

the COVID–19 PHE flexibilities 

continue indefinitely for the duration of 

the ongoing opioid epidemic PHE; 19 

commenters requested that the COVID 

flexibilities continue for six months 

after publication of the final rule, until 

the end of calendar year 2023, or until 

the end of calendar year 2024; and five 

commenters requested that the COVID 

flexibilities continue until the final rule 

is published. 

Response: The NPRM for this final 

rule was published on March 1, 2023, 

and at the time the NPRM was 

published, the COVID–19 PHE 

flexibilities were set to expire on May 

11, 2023. The COVID–19 PHE 

flexibilities have since been temporarily 

extended until December 31, 2025, 

while DEA and, for rules that must be 

issued jointly, HHS have worked on 

other rulemakings. Once published, this 

final rule will be effective February 18, 

2025. DEA and HHS believe this 

effective date, in concert with the latest 

extension of the telemedicine 

flexibilities, satisfies the concerns of 

those who commented on this issue. 

Executive Order 12866—60 Day 

Comment Period 

Comment: DEA and HHS received 

nine comments stating that the 30-day 

comment period found within the 

NPRM violated Executive Order (E.O.) 

12866, which allegedly requires a 60- 

day comment period. 

Response: The language contained 

within E.O. 12866 states ‘‘each agency 

should afford the public a meaningful 

opportunity to comment on any 


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6514 Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Rules and Regulations 

50Executive Order 12866, Regulatory Planning 

and Review, 58 FR 51735 (Oct. 4, 1993) (emphasis 

added). 

51See 21 U.S.C. 821, 21 U.S.C. 871, and 21 U.S.C. 

802(54)(G). 

52As noted previously, DEA understands there 

are situations where the patient (for whom the 

prescription was written) may not be the individual 

picking up the prescription at the pharmacy. In 

these situations, DEA defers to the definition of 

‘‘ultimate user’’ as found in 21 U.S.C. 802(27). As 

such, this regulation authorizes the pharmacist to 

verify the identity of the patient by accepting 

identification from any individual who falls under 

the definition of ‘‘ultimate user’’ prior to filling a 

prescription. 

proposed regulation, which in most 

cases should include a comment period 

of not less than 60 days.’’ 50 Since the 

60-day comment period is not a 

requirement and because, at the time of 

publication of the NPRM, the COVID–19 

PHE telemedicine flexibilities were set 

to expire on May 11, 2023, DEA chose 

to use a 30-day comment period to 

ensure all comments were received and 

to allow adequate time to publish a final 

rule. 

Indian Tribes and Tribal Organizations 

Comment: DEA and HHS received 

two comments regarding the effect of 

this rulemaking on American Indian 

and Alaska Native (AI/AN) Tribes and 

Tribal organizations. One commenter 

requested an exemption from 

registration for all Indian Health Service 

(IHS) and Tribal health system and 

Indian Health Care providers. 

Both commenters indicated that 

consultation and coordination with 

Indian Tribes and Tribal organizations 

is required under Executive Order 

13175 and requested that DEA 

meaningfully consult with Tribal 

officials prior to promulgating the final 

rule. 

Response: DEA and HHS thank these 

commenters for voicing their concerns. 

DEA held Telemedicine Listening 

Sessions on September 12 and 13, 2023, 

and held Tribal Consultations with 

various Tribal governments and 

organizations on June 13 and 27, 2024. 

DEA and HHS have taken the opinions 

and concerns raised during both the 

listening sessions and consultations into 

account when promulgating this final 

rule. As such, DEA and HHS believe the 

requirements of Executive Order 13175 

have been satisfied. 

Other Comments 

Comment: One commenter asked for 

clarification on how patients in various 

stages of buprenorphine treatment 

would be impacted by the rule, given 

the rule’s focus on ‘‘induction’’ of 

buprenorphine. The commenter stated 

that there are various stages of 

buprenorphine treatment, including: (1) 

patients being prescribed 

buprenorphine to initiate therapy 

(general understanding of ‘‘induction’’); 

(2) patients being re-established on 

buprenorphine treatment when 

previously prescribed the controlled 

substance medication; and (3) patients 

being moved from the ‘‘induction’’ 

phase to maintenance phase. The 

commenter sought clarification as to 

whether DEA intended to include all 

these stages under the proposed rule, 

and if not, the commenter asked that the 

rule allow buprenorphine at all stages of 

treatment. 

Response: Both the NPRM and this 

final rule are published with the intent 

of authorizing buprenorphine treatment 

via telemedicine. This final rule allows 

for any patient, beginning on February 

18, 2025, to either begin treatment for 

OUD or continue treatment for OUD 

(i.e., all ‘‘stages’’ of treatment) via audioonly telemedicine encounter if the 

requirements of 42 CFR 410.78(a)(3) are 

met. Beginning on this date, when a 

practitioner provides the patient with a 

prescription or prescription refill for 

buprenorphine as medication for OUD 

via telemedicine, the practitioner must 

review the PDMP prior to issuing the 

prescription. And the pharmacist, prior 

to filling the prescription, must verify 

the identity of the patient. 

Once the initial six-month supply has 

been prescribed, the practitioner and 

patient can choose to continue 

treatment either once an in-person 

medical evaluation has been conducted 

or through other forms of telemedicine 

pursuant to 21 U.S.C. 802(54). In other 

words, a patient has six months from 

the date a prescription (or prescription 

refill) has been issued pursuant to this 

final rule to either obtain an in-person 

medical evaluation or continue with 

another form of telemedicine. 

Comment: DEA and HHS received one 

comment stating DEA lacks the legal 

authority to limit telemedicine 

prescriptions to the FDA-approved 

indications contained in a medication’s 

FDA-approved labeling. This 

commenter argued that DEA would 

effectively be attempting to define 

general standards of accepted medical 

practice, a power which is usually 

reserved for states. 

Response: DEA and HHS, jointly, 

have the legal authority to promulgate 

regulations regarding the practice of 

telemedicine that are consistent with 

the public health and safety.51 DEA 

reiterates that practitioners who are 

otherwise authorized under state and 

Federal law (including under the Ryan 

Haight Act) might prescribe 

buprenorphine for indications other 

than for treatment of OUD. This final 

rule only applies to circumstances 

where the prescribing practitioner has 

not conducted an in-person medical 

evaluation of the patient and is 

otherwise unable to prescribe 

buprenorphine while engaged in the 

practice of telemedicine under 21 U.S.C. 

802(54) but for the authority provided in 

this final rule. 

Comment: One commenter stated that 

DEA should hold an annual review of 

the efficacy and burden of the in-person 

medical evaluation requirement and this 

review should be published in the 

Federal Register. 

Response: DEA appreciates this 

comment and will take this 

recommendation under consideration 

and advisement; however, no definitive 

response can be provided on this issue 

at this time. 

VII. Provisions of the Final Rule 

Under this final rule, a DEA-registered 

practitioner may prescribe 

buprenorphine via audio-only or audiovideo telemedicine encounter as defined 

by 42 CFR 410.78(a)(3). After a 

practitioner reviews the PDMP data for 

the state in which the patient is located 

and annotates in the patient’s EHR that 

such a review was conducted, the 

practitioner may prescribe an initial sixmonth supply of buprenorphine. DEA 

and HHS expect that the practitioner 

will not issue the six-month 

prescription at one time but will rather 

issue prescriptions as medically 

appropriate. Following the initial sixmonth supply, practitioners may 

prescribe buprenorphine only by other 

forms of telemedicine or practices 

authorized by the CSA, or after 

conducting an in-person medical 

examination. Additionally, prior to 

dispensing under this framework, the 

pharmacist will need to verify the 

identity of the patient 52 with either a 

state or Federal Government-issued 

photographic identification card or 

other form of identification. 

A. Prescription Drug Monitoring 

Program Check by Prescribing 

Practitioner 

The regulation at 21 CFR 

1306.51(b)(1), found within this final 

rule, provides that the prescribing 

practitioner must review the PDMP data 

of the state in which the patient is 

located. The prescribing practitioner 

will then need to ensure that the date 

and time of the PDMP review is 

annotated in the patient’s EHR or paper 

record. If, for any reason, the PDMP is 

unavailable or inaccessible and the 


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53No such practices have yet been determined by 

future DEA regulation to be consistent with 

effective controls against diversion. 

54As noted previously, DEA understands there 

are situations where the patient (for whom the 

prescription was written) may not be the individual 

picking up the prescription at the pharmacy. In 

these situations, DEA defers to the definition of 

‘‘ultimate user’’ as found in 21 U.S.C. 802(27). As 

such, this regulation authorizes the pharmacist to 

verify the identity of the patient by accepting 

identification from any individual who falls under 

the definition of an ‘‘ultimate user’’ prior to filling 

a prescription. 

practitioner is unable to review the 

PDMP data for the patient, the 

prescribing practitioner should annotate 

in the patient’s EHR the reason such a 

review was unable to be completed. 

1. If PDMP Data Can Be Reviewed 

Prior to prescribing buprenorphine to 

the patient, the practitioner will be 

required to review the PDMP data of the 

state in which the patient is located and 

ensure that the date and time of such 

review is annotated in the patient’s EHR 

or paper record. The prescribing 

practitioner will be required to review 

the PDMP data for the last year, or if less 

than one year’s worth of data is 

available, for the entire period. The 

inclusion of this requirement prior to 

prescribing is to ensure that the 

practitioner has the information needed 

in order to make the clinical decision of 

whether or not to prescribe 

buprenorphine to a patient under this 

framework. Inherent in the telemedicine 

context, and especially through audioonly means, there may be situations 

where it is difficult for a practitioner to 

ascertain if a patient is being truthful 

about their medical history and prior 

usage of controlled substances. The 

requirement of a mandatory PDMP 

review can furnish the prescribing 

practitioner with valuable information 

regarding a patient’s controlled 

substance prescription history, and by 

using their own clinical judgment, the 

practitioner can make an informed 

decision. 

Regarding the date and time 

requirement, DEA and HHS understand 

that many EHR systems already 

integrate state PDMP data into their 

systems. For these systems, a date and 

time stamp recording when a 

prescribing practitioner reviews PDMP 

data should be automatically integrated 

into the patient’s EHR. For other EHR 

systems where only the date of PDMP 

access is integrated into the patient’s 

EHR or no integrations exist at all, the 

prescribing practitioner will be required 

to manually input the date and time the 

PDMP review was conducted prior to 

closing or signing off on a patient’s 

chart. DEA and HHS understand this 

may be burdensome to practitioners but 

DEA and HHS are confident that as 

technology changes, many EHR systems 

will likely update their platforms to 

enable automatic integration. 

2. If PDMP Data Cannot Be Reviewed 

The regulation at 21 CFR 

1306.51(b)(3) provides that if, for any 

reason, the PDMP data cannot be 

reviewed for a patient, the prescribing 

practitioner should ensure that the 

reason for this is noted in the patient’s 

EHR or paper record. For example, if a 

state PDMP is inaccessible or 

unavailable due to technological issues, 

the prescribing practitioner should note 

the date and time that an attempt to 

view such data was made. In these 

situations, when PDMP data cannot be 

reviewed, a practitioner would only be 

permitted to prescribe an initial sevenday supply of buprenorphine. The 

practitioner may not prescribe an 

additional supply without again 

checking the PDMP data for that patient. 

However, the practitioner would be 

authorized to issue additional limited 

seven-day supply prescriptions (up 

until the six-calendar month limitation 

is reached) if the PDMP remained 

unavailable or inaccessible, as long as 

each time a review is attempted, the 

date and time of each attempt is 

annotated in the patient’s EHR or paper 

record. 

B. Time Limitation of Buprenorphine 

Prescriptions 

The regulation at 21 CFR 

1306.51(b)(2) provides that 

buprenorphine prescriptions issued 

pursuant to audio-visual or audio-only 

telemedicine encounters are limited to a 

period ending no later than six calendar 

months after the date of the first 

prescription. This six-month supply 

must be split across multiple 

prescriptions or refills as the 

practitioner deems medically 

appropriate. Subsequent prescriptions 

may be issued once the practitioner has 

met with the patient for a follow-up 

evaluation either through any other 

form of telemedicine as defined in 21 

U.S.C. 802(54) or through an in-person 

examination of the patient by the 

prescribing practitioner. Additionally, 

this requirement would comport with 

the current regulations found in 21 CFR 

1306.22(a) regarding refilling of 

prescriptions for controlled substances 

listed in schedule III or IV. 

1. Other Authorized Forms of 

Telemedicine or Practices Established 

by Regulation 

After an initial six-month prescription 

of buprenorphine via audio-visual or 

audio-only means, additional 

prescriptions may be written pursuant 

to any other form of telemedicine as 

defined in 21 U.S.C. 802(54). This 

includes the regulations found within 

any final rule that may be issued setting 

forth a special registration framework. 

In the event DEA issues future 

regulations setting forth practices DEA 

determines to be consistent with 

effective controls against diversion, 

pursuant to 21 U.S.C. 829(e)(3)(B), 

additional prescriptions would also be 

permitted to be issued pursuant to those 

practices.53

2. In-Person Medical Evaluation 

Practitioners who conduct an inperson medical evaluation of a patient 

subsequent to the initial six-month 

supply restriction would, from that 

point on, no longer be required to 

adhere to the telemedicine requirements 

established by the Ryan-Haight Act for 

that patient. As explained above, this 

rulemaking contemplates situations 

only wherein the prescribing 

practitioner has never conducted an inperson examination. Once an in-person 

examination has been conducted by the 

prescribing practitioner, the duties and 

obligations found within this final rule 

no longer apply. 

C. ID Requirement for Pharmacists 

Under new 21 CFR 1306.51(b)(4), 

prior to filling a prescription that was 

issued pursuant to the authorities 

created by this final rule, the pharmacist 

will be required to verify that, as a 

general matter, the identity of the 

individual picking up the prescription 

at the pharmacy matches the name of 

the patient listed on the prescription 

itself.54 Before the pharmacist can fill a 

prescription issued pursuant to the 

regulations found in this final rule, they 

must inspect the patient’s state or 

Federal Government-issued 

photographic identification card, or in 

the absence of such identification, any 

other form of documentation showing 

that the patient is the same person as the 

patient listed on the prescription. The 

form of identification presented need 

not contain the patient’s address. Such 

forms of identification include, but are 

not limited to: state issued driver’s 

licenses and identification cards; U.S. 

passport; U.S. military card or military 

dependent’s identification card; Native 

American tribal documents; paycheck; 

bank or credit card statement; utility 

bill; tax bill; or voter registration card. 

For minors under the age of 18, 

unhoused persons, and those without 

photographic identification, examples of 

other permissible forms of identification 

include: school transcripts; school 


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55As noted previously, DEA understands there 

are situations where the patient (for whom the 

prescription was written) may not be the individual 

picking up the prescription at the pharmacy. In 

these situations, DEA defers to the definition of 

‘‘ultimate user’’ as found in 21 U.S.C. 802(27). As 

such, this regulation authorizes the pharmacist to 

verify the identity of the patient by accepting 

identification from any individual who falls under 

the definition of an ‘‘ultimate user’’ prior to filling 

a prescription. 

56Poliwoda, et al. Buprenorphine and its 

formulations: a comprehensive review. Health 

Psychology Research. https://

www.ncbi.nlm.nih.gov/pmc/articles/PMC9392838/. 

Published Aug. 20, 2022. Last accessed Ap. 20, 

2024. 57 21 CFR. 1306.05(a). 

report cards; or a letter from a homeless 

shelter employee or a letter from a 

Tribal government official or other 

Tribal leader verifying the identity of 

the patient. As indicated, the acceptable 

forms of identification provided as 

examples within this final rule are not 

intended to be an exhaustive list. 

As mentioned above, even absent the 

ID provision, DEA and HHS believe that 

the requirements as proposed in the 

NPRM and modified as a result of 

public comment and promulgated 

herein would be sufficient to mitigate 

and provide effective controls against 

diversion under this framework. As a 

result of the Telemedicine Listening 

Sessions, DEA’s survey of state law, 

input received from public comments, 

and DEA’s collaboration with HHS, DEA 

and HHS are promulgating 21 CFR 

1306.51(b)(4) as an additional layer of 

protection against diversion. In sum, 

verifying the identity of the patient prior 

to dispensing is intended to ensure that 

the individual who is receiving the 

controlled substance medication from 

the pharmacist is the same individual 

for whom the prescription was issued. 

During the Telemedicine Listening 

Sessions, seven presenters spoke on the 

importance of verifying a patient’s 

identification prior to dispensing a 

controlled substance. Many of these 

presenters, who are practitioners 

themselves, indicated they already 

require a valid form of identification 

during a telemedicine encounter and 

require patients to provide proof of 

identification prior to prescribing. The 

practitioners subsequently keep a record 

of that identification. These presenters 

emphasized this policy helps to prevent 

illegal access to and misuse of 

medication. Since DEA and HHS believe 

that many prescribers already require 

proof of identification during the 

telemedicine encounter itself and since 

practitioners will be required to review 

PDMP data, DEA and HHS have 

promulgated this identification 

verification requirement for the 

pharmacist to provide an extra layer of 

protection against diversion by ensuring 

the prescription is being dispensed to 

the patient for whom the prescription 

was issued. 

DEA and HHS further believe this 

requirement is a codification of widely 

employed current practice, as many 

state laws currently require pharmacists 

to verify the identity of the patient prior 

to dispensing. DEA conducted a review 

of the laws and regulations of all 50 

states along with the District of 

Columbia and found that there are 

currently 43 states that have an 

identification requirement placed on 

pharmacists prior to filling a 

prescription. The situations in which 

identification verification is required 

varies: some states require verification 

outright, some states indicate that the 

pharmacist ‘‘may’’ verify identification, 

and some states only require verification 

if the patient is ‘‘unknown’’ to the 

pharmacist. Additionally, states vary as 

to what medications require 

verification: some states only require it 

for schedule II controlled substances, 

some for controlled substances found 

within schedules II–V, and some for 

ephedrine or pseudoephedrine products 

or precursors. Since several states 

already impose identification 

verification requirements on 

pharmacists, DEA and HHS do not 

believe imposing this requirement on 

buprenorphine prescriptions will create 

an undue burden on pharmacists. 

Additionally, as DEA and HHS are not 

requiring government-issued photo 

identification, DEA and HHS believe 

providing the pharmacist with any 

documentation that sufficiently verifies 

identity will not be a burden on 

patients. Even though some states do 

not have statutes which mirror this new 

provision, DEA and HHS believe this 

provision largely codifies existing 

practice and assists in mitigating the 

risk of diversion. 

DEA and HHS have thus chosen to 

include this requirement in the context 

of schedule III–V prescriptions for the 

treatment of OUD issued pursuant to 

this final rule, which permits 

prescriptions based on audio-only 

telemedicine encounters, in order to 

assist in reducing the risk of 

unauthorized individuals diverting 

buprenorphine for illicit purposes. DEA 

and HHS believe this additional layer of 

protection will help curtail any 

potential diversion. This identification 

requirement will help ensure that the 

patient using the buprenorphine 

prescription picked up at the pharmacy 

is the same patient that received the 

buprenorphine prescription from the 

audio-only telemedicine encounter.55

Should the identification 

requirements described in 21 CFR 

1306.51(b)(4), or 42 CFR 12.3(b)(4), be 

held to be invalid or unenforceable as 

applied to any person or circumstance, 

or stayed pending agency action, it shall 

be construed so as to continue to give 

the maximum effect to the provision 

permitted by law, including as applied 

to persons not similarly situated or to 

dissimilar circumstances, unless such 

holding is that the identification 

requirements described in 21 CFR 

1306.51(b)(4), or 42 CFR 12.3(b)(4), are 

invalid and unenforceable in all 

circumstances, in which event 21 CFR 

1306.51(b)(4) and 42 CFR 12.3(b)(4), 

shall be severable from the remainder of 

21 CFR 1306.51(b) and 42 CFR 12.3(b). 

D. Scope-Clarifying Provisions 

The three remaining provisions of 21 

CFR 1306.51 serve to clarify the scope 

of the final rule. The regulation at 21 

CFR 1306.51(b)(5) provides that this 

final rule only applies to prescriptions 

issued for the treatment of OUD, even if 

the schedule III–V controlled substance 

approved by the FDA for use in the 

treatment of OUD also has other medical 

uses; for example, there are drugs 

containing buprenorphine that have 

been approved by the FDA to treat acute 

moderate-to-severe pain.56 Though 

buprenorphine-containing drugs have 

other FDA-approved uses, the intention 

of this paragraph, and this final rule 

writ large, is to increase patient access 

to buprenorphine for the treatment of 

OUD. The regulation at 21 CFR 

1306.51(b)(6) makes explicit that this 

final rule only applies to practitioners 

who are already registered, or otherwise 

exempt from registration, to dispense 

buprenorphine. 

Finally, 21 CFR 1306.51(b)(7) 

provides that prescriptions issued 

pursuant to this final rule must 

otherwise comply with relevant DEA 

regulations. For example, a prescription 

issued under this final rule must be 

dated and signed and must include the 

patient’s name and address, the name, 

strength, dosage, form and quantity of 

the drug, directions for use, and the 

practitioner’s name, address, and DEA 

registration number of the 

practitioner.57

VIII. Regulatory Analyses 

Executive Orders 12866, 13563, and 

14094 (Regulatory Review) 

DEA and HHS have determined that 

this rulemaking is a ‘‘significant 

regulatory action’’ under section 3(f) of 

Executive Order 12866, Regulatory 

Planning and Review, but it is not a 

section 3(f)(1) significant action. 

Accordingly, this final rule has been 


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Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Rules and Regulations 6517 

58 ‘‘Monthly summary of telemedicine visits 

matched to a subsequent buprenorphine 

prescription between March 2020 and December 

2021’’, HHS OIG, Mar. 2022. 

59 Ibid. 

60HHS OIG analyzed telemedicine billing codes 

and patient information to identify telemedicine 

visits within a 48-hour period prior to a 

buprenorphine prescription fill associated with the 

same patient, and where the prescribing provider is 

the same as or related to the billing or rendering 

provider of the telemedicine visit. 

61 Id. 

62 Id. 

63HHS OIG, May 2022. 

64Numbers shown are rounded for presentation 

and clarity. Calculations using the provided 

numbers may not yield the same results due to this 

rounding. 

65 IQVIA, National Prescription Audit, September 

2022. 

66Bachhuber MA, Saloner B, LaRochelle M, 

Merlin JS, Maughan BC, Polsky D, Shaparin N, 

Murphy SM. Physician Time Burden Associated 

with Querying Prescription Drug Monitoring 

Programs. Pain Med. 2018 Oct. 

67For the purpose of this analysis, the cost per 

registrant is estimated by multiplying the loaded 

labor rate by the estimated time to complete the 

review. The loaded labor rate is based on the 

estimated loaded hourly wage for 29–1229, 

Physicians, all other. Bureau of Labor Statistics, 

Occupational Employment and Wages, May 2023, 

https://www.bls.gov/oes/current/oes291229.htm. 

The average hourly wage is $119.54, with benefits 

estimated at an additional 42.05% of the base wage. 

The load factor is calculated by comparing the 

benefits for private workers as a share of wages, 

29.6%/70.4% = 42.05%. Bureau of Labor Statistics, 

Continued 

submitted to the Office of Management 

and Budget (OMB) for review. This final 

rule has been drafted and reviewed in 

accordance with Executive Order 12866, 

‘‘Regulatory Planning and Review,’’ 

section 1(b), Principles of Regulation; 

Executive Order 13563, ‘‘Improving 

Regulation and Regulatory Review,’’ 

section 1(b), General Principles of 

Regulation; and Executive Order 14094, 

‘‘Modernizing Regulatory Review.’’ 

DEA and HHS are amending their 

regulations to expand the circumstances 

under which DEA-registered 

practitioners are authorized to prescribe 

schedule III–V controlled substances 

approved by the FDA for the treatment 

of OUD via a telemedicine encounter, 

including an audio-only telemedicine 

encounter. Under these new regulations, 

after a prescribing practitioner reviews 

the patient’s state PDMP data, the 

practitioner can prescribe an initial sixmonth prescription (split amongst 

several prescriptions totaling six 

calendar months) of such medications 

through audio-only means. This final 

rule does not affect practitioner-patient 

relationships in cases where an inperson medical evaluation has 

previously occurred. 

Number of Telemedicine Encounters, 

Providers, and Patients 

The number of telemedicine 

encounters, including audio-only 

telemedicine, leading to buprenorphine 

prescriptions under the temporary 

guidance during the COVID–19 PHE 

forms the basis for estimating the 

number of audio-only telemedicine 

encounters pursuant to this final rule. 

Based on CMS claims data provided 

by the Department of Health & Human 

Services Office of Inspector General 

(HHS OIG), from March 2020, the start 

of the COVID–19 health emergency 

shutdowns, to December 2021, 24,285 

Medicare fee-for-service and managed 

care telemedicine services were 

identified as being linked to 

buprenorphine Part D prescription 

fills.58 These telemedicine services were 

rendered by 7,733 providers to 15,521 

patients.59 Of the 24,285 matching 

telemedicine services, 3,083 were billed 

with audio-only procedure codes, 

rendered by 1,806 providers to 2,548 

patients.60

Based on the CMS data, the 

telemedicine services and associated 

buprenorphine prescriptions identified 

spiked at the beginning of the COVID– 

19 PHE and stayed relatively steady in 

2021. Therefore, 2021 data is used to 

estimate the number of telemedicine 

encounters for this analysis. 

In 2021, there were a total of 

1,929,151 Part D buprenorphine 

prescriptions associated with 1,332,353 

beneficiaries.61 Over the same period, 

there were 11,956 telemedicine 

Medicare fee-for-service and managed 

care telemedicine services, including 

audio-only telemedicine, identified as 

being linked to buprenorphine Part D 

prescriptions fills.62 These telemedicine 

services were provided by 4,533 

providers to 8,182 patients.63 The 

1,929,151 Part D buprenorphine claims 

associated with 1,332,353 beneficiaries 

equates to a ratio of 1.45 64 claims per 

beneficiary. Therefore, the 11,956 

services represent an estimated 8,257 

(11,956/1.45) initial prescriptions, 

which equates to 0.428 percent (8,257/ 

1,929,151) of total Part D claims for 

buprenorphine (1,929,151 total claims). 

Based on IQVIA data, the total number 

of new prescriptions for buprenorphine 

in the U.S. in 2021 was 15,782,652.65

Applying the telemedicine share of total 

Part D buprenorphine prescriptions to 

the estimated number of total services 

associated with a buprenorphine 

prescription yields an estimated 67,552 

(0.428 percent × 15,782,652) initial 

prescriptions. DEA and HHS believe 

this is a high estimate, as the 

telemedicine share of total Part D 

buprenorphine prescriptions may 

include telemedicine services allowed 

by regulation prior to the PHE. 

Affected Persons 

This final rule would affect 

practitioners prescribing schedule III–V 

controlled substances for the treatment 

of OUD using audio-video or audio-only 

technology and the patients being 

treated using this technology. Based on 

the analysis above, DEA and HHS 

expect the final rule to affect 67,552 

patients annually. As previously 

discussed, in 2021, 8,182 patients 

received a prescription for 

buprenorphine under the Medicare Part 

D program, from 4,533 providers, 

equating to a ratio of approximately 1.80 

patients per provider. Applying this 

ratio to the number of affected patients, 

DEA and HHS estimate 37,425 providers 

are affected by this final rule. 

Impact on Physicians or Practitioners 

The final rule would permit the use 

of audio-video or audio-only 

telemedicine provided that (1) the DEAregistered practitioner meets all 

requisite state and Federal registration 

requirements for both prescribing of 

controlled substances and engaging in 

the practice of telemedicine, (2) reviews 

state PDMP data regarding any 

controlled substance prescriptions 

issued to the patient and annotates this 

within the patient’s EHR, (3) is limited 

to prescribing a six-month supply, 

across all such prescriptions, until the 

practitioner conducts an in-person 

medical evaluation or engages in other 

forms of authorized telemedicine, and 

(4) the pharmacist filling the 

prescription confirms the patient 

identity using a valid governmentissued ID or other acceptable form of 

identification. Below is the analysis of 

the four requirements stated above: 

1. DEA Registration Requirement: DEA 

and HHS assume all practitioners who 

would issue prescriptions via 

telemedicine encounters pursuant to 

this final rule are authorized under DEA 

regulations under 21 CFR 

1301.13(e)(1)(iv) as well as the states 

where the practitioner is located (unless 

otherwise excepted). Therefore, the 

impact of this requirement is minimal. 

2. Review PDMP data and annotate 

within the EHR: Based on a 2018 study, 

it takes a practitioner 27 seconds to log 

in and 37 seconds to retrieve a report 

once logged in. The total time it takes 

to retrieve a PDMP report is roughly a 

minute (27 + 37 = 64 seconds) or 0.0167 

of an hour (1/60).66 Based on an 

estimated loaded hourly rate of 

$169.80,67 the cost of a review of the 


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6518 Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Rules and Regulations 

Employer Costs for Employee Compensation— 

December 2023, https://www.bls.gov/news.release/ 

archives/ecec_03132024.pdf. The loaded wage was 

therefore $119.54 × 1.4205 = $169.80 per hour for 

private physicians, all other. 

68Numbers shown are rounded for presentation 

and clarity. Calculations using the provided 

numbers may not yield exactly the same results due 

to this rounding 

69How much does opioid treatment cost?, NIDA. 

(Apr. 13, 2021), https://nida.nih.gov/publications/ 

research-reports/medications-to-treat-opioidaddiction/how-much-does-opioid-treatment-cost. 

70Fairley et al.. Cost-effectiveness of Treatments 

for Opioid Use Disorder. JAMA Psychiatry (July 1, 

2021). 

71Florence C, Luo F, Rice K. The economic 

burden of opioid use disorder and fatal opioid 

overdose in the United States, 2017. Drug Alcohol 

Depend. 2021;218:108350. doi:10.1016/ 

j.drugalcdep.2020.108350. 

72 Id. 

PDMP is $2.83 ($169.80 × 0.0167). 

Applying this cost to 67,552 services, 

the total cost of PDMP review is 

$191,171 ($2.83 × 67,552), annually.68

While many practitioners already check 

PDMP data prior to issuing a 

prescription for controlled substances 

for a variety of reasons, DEA and HHS 

will consider the full cost of checking 

the PDMP, $191,171, as a cost of this 

final rule to be conservative. 

3. Limited to a six-month supply: 

Increasing the limit to a six-month 

supply under this final rule will give 

patients and prescribing practitioners 

more time to schedule follow-up 

appointments and reduce the likelihood 

of a relapse by a patient due to lack of 

medication, and will allow prescribing 

practitioners greater flexibility in 

managing their patient populations. 

While DEA and HHS do not have a basis 

to quantify the economic impact of the 

six-month supply limit, six months of 

medication for treatment is believed to 

be a net benefit compared to a baseline 

of zero to seven days of medication for 

treatment. 

4. Pharmacist ID verification: 

Pharmacists must verify the patient’s 

identity with either a state or Federal 

Government-issued photographic 

identification card, or another 

acceptable form of identification as 

listed above. The practice of checking 

identification when providing 

prescriptions is already well-established 

and widespread, and DEA expects any 

additional labor costs for pharmacists to 

be minimal. 

In summary, the total cost to 

practitioners is $191,171 annually, 

which is the cost associated with 

checking PDMPs. 

Impact on Patients 

As discussed earlier, DEA and HHS 

estimate this final rule will affect 67,552 

patients per year. DEA and HHS 

anticipate that patients will fall into one 

of two categories: 

(1) Patients who would otherwise not 

receive treatment or prescriptions for 

OUD absent this final rule. These 

patients have no other means to receive 

treatment. They are unable to visit a 

practitioner in-person or otherwise visit 

a practitioner engaged in the practice of 

telemedicine as defined in 21 CFR 

1300.04(i), but are able to have an 

audio-video or audio-only telemedicine 

visit pursuant to this final rule. 

(2) Patients who would eventually 

receive treatment and prescriptions 

even absent the final rule. These 

patients are able to either visit a 

practitioner in-person or have a 

telemedicine visit with a practitioner 

engaged in the practice of telemedicine 

as defined in 21 CFR 1300.04(i); 

however, such visit is delayed for any 

variety of reasons, e.g., long wait times 

for an appointment with the 

practitioner, personal hardship, etc. 

This final rule, if implemented, would 

create additional flexibilities, 

potentially allowing the patient to more 

quickly start treatment, absent this final 

rule. 

DEA and HHS do not have a basis to 

estimate how many of the estimated 

67,552 patients fall into the two groups. 

However, DEA and HHS anticipate a 

larger impact for the first group. The 

impact on the first group of patients is 

a result of receiving treatment for OUD. 

There would be a cost of treatment and 

the benefit generated from the 

treatment, which would not have been 

possible without this final rule. The 

impact on the second group would be 

the result of receiving treatment sooner 

than they would have without this final 

rule. For both groups, the impact could 

potentially be lifesaving. However, DEA 

and HHS do not have access to data that 

would permit them to estimate the 

number of lives the improved access 

could save. There would be a cost of 

treatment and the benefit of earlier 

treatment, including potential costoffsets associated with reduced 

healthcare and public safety 

expenditures. According to a December 

2021 research report, treatment costs 

with buprenorphine for a stable patient 

provided in a certified Opioid 

Treatment Program, including 

medication and twice-weekly visits, 

were $115 per week or $5,980 per 

year.69 This is likely higher than the 

cost of treating a stable patient in a 

primary care setting, where patients are 

more likely to see providers once per 

week and where there are no associated 

specialized costs. However, using the 

$5,980 per year estimate serves to 

establish an upper boundary for 

potential costs in any cost-benefit 

comparison. Estimates of the impact of 

buprenorphine use in the treatment of 

OUD suggests a 23.7% decrease in total 

deaths, and 31.2% reduction in drug 

poisonings (both fatal and nonfatal). In 

total, the combined cost-savings of 

buprenorphine (including both healthcare costs as well as criminal justice 

costs) was estimated by one study at 

$60,000 per person.70 At the costs listed 

above, the savings from the treatment of 

one person would cover the cost of 

buprenorphine treatment for ten others. 

A study published in 2021 of the 

societal costs for OUD found that the 

‘‘costs for opioid use disorder and fatal 

opioid overdose in 2017 were estimated 

to be $1.02 trillion. The majority of the 

economic burden is due to reduced 

quality of life from opioid use disorder 

and the value of life lost due to fatal 

opioid overdose.’’ 71 According to the 

report, in 2017 total non-fatal costs were 

$471 billion and total fatal costs were 

$550 billion and there were 2.1 million 

persons ages 12 years and older with 

OUD, and 47,000 fatal opioid 

overdoses.72 Non-fatal costs include 

costs associated with health care, 

substance use disorder treatment, 

criminal justice, lost productivity, and 

the value of reduced quality of life. 

Dividing the total non-fatal cost of $471 

billion by the number of persons ages 12 

and older with OUD of 2.1 million, the 

societal cost of non-fatal OUD is 

approximately $224,000 ($471 billion/ 

2.1 million) per person per year. While 

DEA and HHS are unable to quantify 

how many of the affected patients will 

be successfully treated for OUD or how 

many fatal opioid overdoses will be 

avoided as a result of this final rule, the 

potential economic benefit is 

disproportionally large compared to any 

cost associated with this rule. 

Risk of Diversion 

This final rule will reduce the 

requirements imposed on practitioners 

who wish to prescribe schedule III–V 

controlled substances as part of 

treatment for OUD. DEA and HHS 

understand that there is potential for the 

misuse of controlled substances 

approved for OUD treatment, which 

could be worsened by an increase in 

prescribing. 

While this final rule may increase the 

risk of diversion, with the safeguards, 

DEA and HHS estimate this increased 

risk will be minimal. Requirements to 

check the state PDMP prior to issuance 

of a prescription, in-person 

requirements for follow-up 


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73Han, Beth et al. ‘‘Trends in and Characteristics 

of Buprenorphine Misuse Among Adults in the 

US.’’ JAMA Netw Open. 2021 Oct 1; 

4(10):e2129409. Accessed 9/15/2022. 

74 Id. 75Prevoznik Letter. 

appointments under current law, and 

the requirement that pharmacists verify 

identification prior to filling a 

prescription are expected to minimize 

the diversion of buprenorphine via 

telemedicine, including audio-only 

telemedicine. Practitioners already have 

the authority to prescribe 

buprenorphine. Studies have found that, 

in 2019, the percentage of 

buprenorphine misuse among adults 

with past-year use was 29.2%. Of those 

adults who misused buprenorphine in a 

previous year, 71.8%–74.7% did not 

have their own prescription.73 Given the 

misuse of buprenorphine is often for 

self-treatment of OUD symptoms, these 

numbers underscore the need for 

expanded access to buprenorphine 

treatment for OUD. 

The growth of waivers to prescribe 

buprenorphine was slower among 

prescribers working in small 

nonmetropolitan counties than urban 

counties. Prescribers in rural counties 

were associated with low 

buprenorphine dispensing.74 DEA and 

HHS believe that by providing increased 

access for rural areas, the benefits of 

increasing access to buprenorphine 

outweigh any added risk of diversion as 

the result of this rule. 

Other Potential Costs 

DEA and HHS also examined the cost 

of technology, both capital investment 

and operation expenses, in order to 

provide audio-only telemedicine in 

compliance with the final rule. DEA and 

HHS believe that the use of 

telemedicine will not require any 

additional capital expenditures on the 

part of practitioners or patients. 

Recordkeeping requirements are likely 

to have a minimal impact because 

current recordkeeping practices are 

likely to meet the requirements imposed 

by the final rule, and any additional 

time is expected to be minimal. EHRs 

may be updated in the future to reflect 

the final rule change, such as the 

integration of state PDMP data into a 

patient’s EHR, but such changes are 

likely to be minor and included as part 

of any normal software update. 

Summary 

In summary, DEA and HHS estimate 

this rule would affect 37,425 providers 

and 67,552 patients, annually. DEA and 

HHS believe that this rule would 

increase patient access to 

buprenorphine for two types of patients: 

those who otherwise would be unable or 

unwilling to seek treatment, as well as 

those who would seek treatment but 

with some form of delay. Increased 

access to buprenorphine is expected to 

reduce the number of opioid drug 

poisonings annually, however, DEA and 

HHS cannot quantify the size or total 

benefits of such a reduction. There 

would be a slight increase in labor costs 

per practitioner, due to increased time 

spent reviewing PDMP databases. The 

estimated total cost to the 37,425 

providers is $191,171 annually. DEA 

and HHS estimate recordkeeping 

requirements are likely to have a 

minimal impact because current 

recordkeeping practices are likely to 

meet the requirements imposed by this 

final rule, and any additional time is 

expected to be minimal. The increase in 

the availability and flexibility of 

treatment with schedule III–V 

controlled substances may increase the 

risk of diversion, however DEA and 

HHS believe that any increase would be 

small and outweighed by the benefit to 

patients and reduction in the societal 

cost of OUD. 

Executive Order 12988, Civil Justice 

Reform 

This final 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 final rule does not have 

federalism implications warranting the 

application of E.O. 13132. The final rule 

does not have substantial direct effects 

on the States, on the relationship 

between the National Government and 

the States, or on the distribution of 

power and responsibilities among the 

various levels of government. 

Executive Order 13175, Consultation 

and Coordination With Indian Tribal 

Governments 

DEA and HHS are committed to the 

principles of collaboration and 

consultation with Tribal governments, 

as demonstrated through its plans to 

conduct the appropriate Executive 

Order 13175 Tribal consultations and 

recognizes the significance of these 

consultations and their role in shaping 

regulations that impact Tribal 

communities. DEA and HHS have 

determined that there is a reasonable 

basis to believe that this rule may have 

Tribal implications, consistent with the 

definition in Executive Order 13175. 

On June 13 and 27, 2024, DEA held 

virtual consultations with numerous 

Tribal governments and organizations. 

DEA and HHS considered the valuable 

insights from Tribal persons and 

organizations received during the 

comment period of the Buprenorphine 

NPRM from March 2023 (88 FR 12890), 

the Telemedicine Listening Sessions 

held in September 2023, and the most 

recent virtual consultations from June 

2024. DEA’s intentions have been to 

engage in consultations as appropriate 

throughout the rulemaking process, 

fostering a collaborative environment 

that respects the sovereignty and 

interests of Tribal governments, while 

enhancing the overall quality and 

effectiveness of DEA’s regulatory efforts. 

As such, DEA and HHS have 

incorporated these concerns, as 

necessary, within this final rule to 

ensure DEA and HHS’s regulations align 

with the diverse needs and 

considerations of various stakeholders 

impacted by DEA oversight. 

Regulatory Flexibility Act 

The Administrator and the Secretary, 

in accordance with the Regulatory 

Flexibility Act (5 U.S.C. 601–612) 

(RFA), have reviewed this proposed rule 

and by approving it certifies that it will 

not have a significant economic impact 

on a substantial number of small 

entities. 

Due to the COVID–19 PHE, DEA 

issued guidance which authorized 

prescribing of buprenorphine to new 

and existing patients with OUD via 

telephone by otherwise authorized 

practitioners without requiring such 

practitioners to first conduct an 

examination of the patient in person.75

To continue the flexibilities of audioonly telemedicine prescribing of 

schedule III–V controlled substances 

approved by the FDA for the treatment 

of OUD beyond the COVID–19 PHE, 

DEA and HHS have promulgated 

regulations which would balance the 

need to increase patient access to 

legitimate medical treatment with the 

goal of providing effective controls 

against diversion. Thus, within this 

final rule, DEA and HHS are explaining 

the conditions in which a practitioner is 

authorized to prescribe buprenorphine 

via an audio-only telemedicine 

encounter, and the obligations which 

arise once a practitioner prescribes to 

patients. 

Affected Persons 

This final rule affects DEA-registered 

practitioners prescribing schedule III–V 

controlled substances for the treatment 

of OUD via telemedicine, including 

audio-only telemedicine. As stated 


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6520 Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Rules and Regulations 

76SUSB’s employer data contain the number of 

firms, number of establishments, employment, and 

annual payroll for employment size of firm 

categories by location and industry. A ‘‘firm’’ is 

defined as an aggregation of all establishments 

owned by a parent company (within a geographic 

location and/or industry) with some annual payroll. 

Small Business Administration, Firm Size Data, 

https://www.sba.gov/advocacy/firm-size-data (last 

visited Apr 25, 2024). The data table is available at 

https://www.sba.gov/sites/default/files/files/static_

us_11.xls (last visited April 25, 2024). 

above, DEA and HHS estimate this final 

rule will affect 37,425 DEA-registered 

practitioners and 67,552 patients 

annually. Because patients are 

individuals and not small entities, this 

analysis examines the impact of the 

final rule on affected practitioners and 

small entities that employ the affected 

practitioners. 

With respect to practitioners, this 

final rule would permit the use of 

audio-only telemedicine provided that 

the practitioner (1) meets all requisite 

state and Federal registration 

requirements for both prescribing of 

controlled substances and engaging in 

the practice of telemedicine, (2) reviews 

PDMP data regarding any controlled 

substance prescriptions issued to the 

patient in the previous year, and (3) is 

limited to prescribing a six-month 

supply, across all such prescriptions, 

until the practitioner conducts an inperson medical evaluation or engages in 

other forms of telemedicine. 

A significant number of practitioners 

work in offices and institutions that 

meet the RFA’s definition of small 

entities. To estimate the number of 

affected entities, DEA and HHS first 

determined the North American 

Industry Classification System (NAICS) 

codes that most closely represent 

businesses that would employ the 

practitioners who would prescribe 

buprenorphine via an audio-only 

telemedicine encounter. Then, DEA and 

HHS researched economic data for those 

codes. The source of the economic data 

is the Small Business Administration 

(SBA) Office of Advocacy, and is based 

on data provided by the U.S. Census 

Bureau Statistics of U.S. Businesses 

(SUSB).76 The following business 

NAICS codes are estimated to represent 

businesses that employ the affected 

persons: 

• 621111—Offices of Physicians, Except 

Mental Health Specialists 

• 621112—Offices of Physicians, 

Mental Health Specialists 

• 621420—Outpatient Mental Health 

and Substance Abuse Centers 

• 622110—General Medical and 

Surgical Hospitals 

• 622210—Psychiatric and Substance 

Abuse Hospitals 

SUSB data contains the number of 

firms by size ranges for each of the 

NAICS codes. For the purposes of this 

analysis, the term ‘‘firm’’ as defined in 

the SUSB is used interchangeably with 

‘‘entity’’ as defined in the RFA. 

To estimate the number of affected 

entities that are small entities, DEA and 

HHS compared the SUSB data for the 

number of firms in various firm size 

ranges with SBA size standards for each 

of the representative NAICS codes. The 

SBA size standard is the firm size based 

on the number of employees or annual 

receipts depending on industry. The 

SBA size standards for NAICS codes 

621111, 621112, 621420, 622110, and 

622210 are annual receipts of $14 

million, $12 million, $16.5 million, 

$41.5 million, and $41.5 million, 

respectively. 

The firms in each size range below the 

SBA size standard are small firms. The 

number of firms below the SBA size 

standard was added to determine the 

total number of small firms in each 

NAICS code. DEA and HHS estimate 

there are 161,286, 10,561, 6,523, 2,560, 

and 396 entities in the 621111, 621112, 

621420, 622110, and 622210 industries. 

Based on the SUSB data on the firm 

sizes, DEA and HHS estimate there are 

157,060, 10,392, 5,849, 1,047, and 204 

small entities in the 621111, 621112, 

621420, 622110, and 622210 industries. 

In total, DEA and HHS estimate there 

are 181,326 entities in the three 

potentially affected industries, of which 

174,552 (96.3 percent) are small entities. 

The analysis is summarized in table 1 

below. 

TABLE 1—NUMBER OF AFFECTED ENTITIES AND SMALL ENTITIES

NAICS code Number of 

firms 

SBA size 

standard 

($) 

Number of 

small firms * 

621111—Offices of Physicians, Excepting Mental Health Specialists ........................................ 161,286 14,000,000 157,060 

621112—Offices of Physicians, Mental Health Specialists ......................................................... 10,561 12,000,000 10,392 

621420—Outpatient Mental Health and Substance Abuse Centers ........................................... 6,523 16,500,000 5,849 

622110—General Medical and Surgical Hospitals ...................................................................... 2,560 41,500,000 1,047 

622210—Psychiatric and Substance Abuse Hospitals ............................................................... 396 41,500,000 204 

Total ...................................................................................................................................... 181,326 ........................ 174,552 

Percent of Total .................................................................................................................... ........................ ........................ 96.3% 

* Not all decimal places shown. 

From above, E.O. 12866 section, DEA 

and HHS estimate that audio-only 

telemedicine services will be provided 

by 37,425 providers to 67,552 patients, 

annually. Therefore, this final rule is 

estimated to affect 37,425 individual 

practitioners employed by some of the 

174,552 small businesses in industries 

potentially affected by this final rule. 

Since some small entities will employ 

more than one practitioner, the number 

of affected small entities is expected to 

be less than 37,425 and is expected to 

be concentrated in the 621111, 621112, 

and 621420 industries, with a combined 

total of 173,301 small entities. 

Therefore, the number of small entities 

affected by this final rule is estimated to 

be approximately 21.6%, which is a 

substantial number of the representative 

industries. 

The cost of the final rule will impact 

the affected entities and small entities 

on a ‘‘per person’’ basis. Rather than 

estimating the number of practitioners 

per firm, then the cost per firm, then 

whether the cost is significant, DEA and 

HHS employed a more direct approach 

based on the following logic: 

• In order to continue, the affected 

firms must generate enough revenue to 

pay the wages of practitioners, and other 

operating expenses. 

• Therefore, revenue for firms must 

be greater than the wages paid to 

practitioners. 

• Therefore, if the cost of the final 

rule is not economically significant 

when compared to individual wages for 

practitioners, the cost of the final rule is 

not economically significant when 


KHAMMOND on DSK9W7S144PROD with RULES6
Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Rules and Regulations 6521 

77Numbers shown are rounded for presentation 

and clarity. Calculations using the provided 

numbers may not yield exactly the same results due 

to this rounding 

78Bureau of Labor Statistics, Occupational and 

Employment and Wages, May 2023, 29–1229 

Physicians, All Others, http://www.bls.gov/oes/ 

current/oes291229.htm. 

79Bureau of Labor Statistics, Occupational and 

Employment and Wages, May 2023, 29–1071 

Physician Assistants, http://www.bls.gov/oes/ 

current/oes291071.htm. Bureau of Labor Statistics, 

Occupational and Employment and Wages, May 

2023, 29–1171 Nurse Practitioners, http://

www.bls.gov/oes/current/oes291171.htm. DEA 

calculated the weighted average hourly wage based 

on the distribution of physician assistants (36.2%) 

and nurse practitioners (63.8%). 

compared to the annual revenue of the 

firms. 

From 2021 data provided by CMS, 

DEA and HHS estimate that 67,552 

patients received telemedicine services 

prior to receiving a prescription for 

buprenorphine. These services were 

provided by 37,425 separate providers, 

for approximately 1.8 77 patients per 

provider. 

DEA and HHS estimate a non-loaded 

median hourly wage of $119.54 78 and 

$62.11 79 for potentially affected 

physicians and MLPs, respectively. 

Applying the hourly wage rates to the 

estimated time to apply, DEA and HHS 

estimate the labor cost per PDMP review 

is $1.99 ($119.54 × 1/60) and $1.04 

($62.11 × 1/60) per physician and MLP, 

respectively. The non-loaded wage rates 

are calculated to represent the cost to 

the individual, whereas previously the 

loaded wage rates were calculated to 

represent the total cost of employment 

to the entity and to the economy. These 

rates are multiplied by 1.8 patients, for 

total labor costs of $3.59 and $1.88, 

respectively. 

The loaded unit cost of conducting a 

PDMP review is compared to the nonloaded annual wage rate for 

practitioners. Based on the Bureau of 

Labor Statistics’ (‘‘BLS’’) Occupational 

and Employment and Wages data, DEA 

and HHS estimate an average annual 

wage of $248,640 for physicians and 

$118,553 for MLPs. Unit costs of $3.59 

and $1.88 represent 0.001 0.002 percent 

of those wages. Table 2 presents the 

details of the calculation. 

TABLE 2—COSTS AND FEES AS PERCENT OF WAGES

Mean hourly 

wage 

($) 

Time to review 

(hours) 

Cost per 

patient 

($) 

Cost per 1.8 

patients 

($) 

Mean annual 

wage 

($) 

Additional 

costs as 

percent of 

wage 

(%) 

Physicians ................................................ 119.54 0.0167 1.99 3.59 248,640 0.001 

MLP .......................................................... 62.11 0.0167 1.04 1.88 118,553 0.002 

The economic impact of additional 

time spent conducting PDMP reviews 

represents a small fraction (0.001 and 

0.002 percent) of annual wages. DEA 

and HHS estimate this final rule will not 

have a significant economic impact on 

individual practitioners. The entities 

and small entities that employ the 

potentially affected practitioners are 

expected to generate enough revenue to 

pay their wages. 

In addition to DEA-registered 

prescribers detailed above, the proposed 

rule would require pharmacists to verify 

the identification of any person 

receiving a prescription for 

Buprenorphine via an audio-only 

telemedicine visit. Identity verification 

is already a common practice and DEA 

believes that this would not impose any 

significant additional time or labor costs 

to the actions of pharmacist registrants. 

Therefore, DEA and HHS conclude this 

final rule will not have a significant 

economic impact on a substantial 

number of small entities. 

Unfunded Mandates Reform Act of 1995 

The estimated annual impact of this 

rule is minimal. Thus, DEA and HHS 

have 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 

Pursuant to subtitle E of the Small 

Business Regulatory Enforcement 

Fairness Act of 1996 (also known as the 

Congressional Review Act), the Office of 

Information and Regulatory Affairs has 

determined that this rule does not meet 

the criteria set forth in 5 U.S.C. 804(2). 

Paperwork Reduction Act of 1995 

This final rule is finalizing a new 

collection of information under the 

Paperwork Reduction Act (PRA), 44 

U.S.C. 3501–3521. As required under 

PRA, DEA proposed the creation of a 

new collection of information in the 

NPRM, which OMB assigned the 

following control number: 1117–NEW. 

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. 

Copies of existing information 

collections approved by OMB may be 

obtained at http://www.reginfo.gov/ 

public/do/PRAMain. 

A. Collections of Information Associated 

With the Final Rule 

1. Title: Recordkeeping Related to 

PDMP. 

OMB Control Number: 1117–NEW. 

Form Number: N/A. 

DEA and HHS are amending their 

regulations by authorizing initiation of 

schedule III–V controlled medications 

approved for use in the treatment of 

OUD via telemedicine encounter, to 

include audio-only means. Prior to 

prescribing, the practitioner must 

review the PDMP data of the state in 

which the patient is located and 

annotate the date and time that such a 

review was conducted in the patient’s 

EHR. If the PDMP is unavailable or 

inaccessible for any reason, the 

prescribing practitioner must annotate 

the date and time that such a review 

was attempted in the patient’s EHR and 

provide a reason as to why a review was 

unable to be completed. 

DEA and HHS estimate the following 

number of respondents and burden 

associated with this collection of 

information: 

• Number of respondents: 37,425. 

• Frequency of response: 1.804996. 

• Number of responses: 67,552. 

• Burden per response: 1 minute 

(0.01666667 hours). 

• Total annual hour burden: 1,126 

Hours. 

If you need a copy of the information 

collection instrument(s) with 


KHAMMOND on DSK9W7S144PROD with RULES6
6522 Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Rules and Regulations 

instructions or additional information, 

please contact the Regulatory Drafting 

and Policy Support Section (DPW), 

Diversion Control Division, Drug 

Enforcement Administration; Mailing 

Address: 8701 Morrissette Drive, 

Springfield, Virginia 22152; Telephone: 

(571) 362–3261. 

Any additional comments on this 

collection of information may be sent in 

writing to the Office of Information and 

Regulatory Affairs, OMB, Attention: 

Desk Officer for DOJ, Washington, DC 

20503. Please state that your comment 

refers to OMB Control Number 1117– 

NEW. 

List of Subjects 

21 CFR Part 1306 

Administrative practice and 

procedure, Drug traffic control, 

Prescription drugs, Reporting and 

recordkeeping requirements. 

42 CFR Part 12 

Administrative practice and 

procedure. 

Signing Authority 

This document of the Drug 

Enforcement Administration was signed 

on January 13, 2025, by Administrator 

Anne Milgram. That document with the 

original signature and date is 

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. 

DRUG ENFORCEMENT 

ADMINISTRATION 

For the reasons set out above, the 

Drug Enforcement Administration 

amends 21 CFR part 1306 as follows: 

PART 1306—PRESCRIPTIONS 

■ 1. The authority citation for part 1306 

continues to read as follows: 

Authority: 21 U.S.C. 821, 823, 829, 829a, 

831, 871(b) unless otherwise noted. 

§§ 1306.28 through 1306.49 [Added and 

Reserved] 

■ 2. Add reserved §§ 1306.28 through 

1306.49. 

■ 3. Add an undesigned center heading 

and § 1306.51 to read as follows: 

Special Circumstances for 

Telemedicine Prescribing 

§ 1306.51 Telemedicine prescribing of 

schedule III–V medications for the treatment 

of Opioid Use Disorder. 

(a) For purposes of this section, terms 

defined in part 1300 of this chapter, 

elsewhere in this chapter, 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. The prescribing 

practitioner must be authorized to 

access the applicable prescription drug 

monitoring program (PDMP) data of the 

state in which the patient is located at 

the time of the telemedicine encounter. 

The prescribing practitioner shall 

review such data regarding any 

controlled substance prescriptions 

issued to the patient in the last year, or, 

if less than one year of data is available, 

in the entire available period. The 

prescribing practitioner shall ensure the 

date and time of such a review is 

annotated in the patient’s electronic 

health record (EHR) or paper record. 

This review, or attempted review, must 

be conducted prior to issuing a 

prescription in a manner authorized 

under this section. 

(2) Time limit. The practitioner may 

issue prescriptions to the patient 

pursuant to this section for a period not 

to exceed six calendar months 

beginning on the date the first 

prescription is issued. The practitioner 

may issue additional prescriptions to 

the patient for schedule III–V controlled 

substances approved by the FDA for use 

in the treatment of OUD either: 

(i) 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); or 

(ii) As otherwise 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). 

(3) PDMP inaccessible or unavailable. 

If the PDMP data is inaccessible or 

unavailable for any reason, the 

prescribing practitioner shall annotate 

in the patient’s EHR or paper record the 

date and time that an attempt to view 

the PDMP data was made and the reason 

the data could not be reviewed. A 

practitioner may prescribe a seven-day 

supply of medication and must perform 

another PDMP review before prescribing 

another seven-day supply. Each time the 

PDMP is reviewed or attempted to be 

reviewed, the date and time must be 

annotated in the patient’s EHR. A sevenday supply prescribed pursuant to this 

paragraph (b)(3) counts toward the time 

limit described in paragraph (b)(2) of 

this section. 

(4) Pharmacy identification 

requirement. The pharmacist shall 

verify the identity of the patient prior to 

filling a controlled substance 

prescription issued under the authority 

of this section. The pharmacist shall 

verify the identity of the patient with a 

state or Federal Government-issued 

photographic identification card or 

other form of identification. For the 

purposes of verifying the identity of the 

patient, the pharmacist may accept 

identification in the manner described 

herein from any qualifying ‘‘ultimate 

user’’ as defined in 21 U.S.C. 802(27) 

prior to filling the prescription. 

(5) Prescription only for treatment of 

OUD. Controlled substance 

prescriptions issued pursuant to this 

section may only be issued for the 

treatment of OUD, and subject to the 

requirements of this section. 

(6) Authorization to prescribe. The 

practitioner must be: 

(i) Authorized under §§ 1301.11, 

1301.12(a), and 1301.13(e)(1)(iv) of this 

chapter 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). 

(7) Consistent with general 

prescription requirements. The issuance 

of the controlled substance prescription 

otherwise complies with the 

requirements set forth in this part. 

Department of Health and Human 

Services 

For the reasons set out above, the 

Department of Health and Human 


KHAMMOND on DSK9W7S144PROD with RULES6
Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Rules and Regulations 6523 

1 88 FR 12875 (Mar. 1, 2023). 

Services amends 42 CFR part 12 as 

follows: 

PART 12—TELEMEDICINE 

FLEXIBILITIES 

■ 4. The authority citation for part 12 

continues to read as follows: 

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

■ 5. Add subpart B to read as follows: 

Subpart B—Telemedicine Prescribing 

§ 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. The prescribing 

practitioner must be authorized to 

access the applicable prescription drug 

monitoring program (PDMP) data of the 

state in which the patient is located at 

the time of the telemedicine encounter. 

The prescribing practitioner shall 

review such data regarding any 

controlled medication prescriptions 

issued to the patient in the last year, or, 

if less than one year of data is available, 

in the entire available period. The 

prescribing practitioner shall ensure the 

date and time of such a review is 

annotated in the patient’s electronic 

health record (EHR) or paper record. 

This review, or attempted review, must 

be conducted prior to issuing a 

prescription in a manner authorized 

under this section. 

(2) Time limit. The practitioner may 

issue prescriptions to the patient 

pursuant to this section for a period not 

to exceed six calendar months 

beginning on the date the first 

prescription is issued. The practitioner 

may issue additional prescriptions to 

the patient for schedule III–V controlled 

substances approved by the FDA for use 

in the treatment of OUD either: 

(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. 

If the PDMP data is inaccessible or 

unavailable for any reason, the 

prescribing practitioner shall annotate 

in the patient’s EHR or paper record the 

date and time that an attempt to view 

the PDMP data was made and the reason 

the data could not be reviewed. A 

practitioner may prescribe a seven-day 

supply of medication and must perform 

another PDMP review before prescribing 

another seven-day supply. Each time the 

PDMP is reviewed or attempted to be 

reviewed, the date and time must be 

annotated in the patient’s EHR. A sevenday supply prescribed pursuant to this 

paragraph (b)(3) counts toward the time 

limit described in paragraph (b)(2) of 

this section. 

(4) Pharmacy identification 

requirement. The pharmacist shall 

verify the identity of the patient prior to 

filling a controlled medication 

prescription issued under the authority 

of this section. The pharmacist shall 

verify the identity of the patient with a 

state or Federal Government-issued 

photographic identification card or 

other form of identification. For the 

purposes of verifying the identity of the 

patient, the pharmacist may accept 

identification in the manner described 

herein from any qualifying ‘‘ultimate 

user’’ as defined in 21 U.S.C. 802(27) 

prior to filling the prescription. 

(5) Prescription only for treatment of 

OUD. Controlled medication 

prescriptions issued pursuant to this 

section may only be issued for the 

treatment of OUD. 

(6) Authorization to prescribe. The 

practitioner must be: 

(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. The issuance 

of the controlled substance prescription 

otherwise complies with the 

requirements set forth in 21 CFR part 

1306. 

[FR Doc. 2025–01049 Filed 1–15–25; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

21 CFR Part 1306 

[Docket No. DEA–407VA] 

RIN 1117–AB40; 1117–AB88 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

42 CFR Part 12 

Continuity of Care via Telemedicine for 

Veterans Affairs Patients 

AGENCY: Drug Enforcement 

Administration, Department of Justice; 

Substance Abuse and Mental Health 

Services Administration, Department of 

Health and Human Services. 

ACTION: Final rule. 

SUMMARY: This final rule authorizes 

Department of Veterans Affairs (VA) 

practitioners acting within the scope of 

their VA employment to prescribe 

controlled substances via telemedicine 

to a VA patient with whom they have 

not conducted an in-person medical 

evaluation. VA practitioners are 

permitted to prescribe controlled 

substances to VA patients if another VA 

practitioner has, at any time, previously 

conducted an in-person medical 

evaluation of the VA patient, subject to 

certain conditions. 

DATES: This final rule is effective 

February 18, 2025. 

FOR FURTHER INFORMATION CONTACT: 

Heather Achbach, Regulatory Drafting 

and Policy Support Section, Diversion 

Control Division, Drug Enforcement 

Administration; Telephone: (571) 776– 

3882. 

SUPPLEMENTARY INFORMATION: This rule 

is a final rule that finalizes portions of 

the proposed rule titled Telemedicine 

Prescribing of Controlled Substances 

When the Practitioner and the Patient 

have Not Had a Prior In-Person Medical 

Evaluation, specifically those proposed 

regulations affecting VA practitioners 

prescribing controlled substances.1

Under this final rule, a VA practitioner 

who is acting within their scope of 

employment with the VA may prescribe 

controlled substances while engaged in 

the practice of telemedicine with a VA 

patient with whom they have not 

conducted an in-person medical 

evaluation, if another VA practitioner 

has previously conducted an in-person 

medical evaluation with the VA patient. 

Additionally, prior to issuing a 

prescription via telemedicine for a 


KHAMMOND on DSK9W7S144PROD with RULES6