Telemedicine Prescribing of Controlled Substances in 2026:What Clinicians Need to Know — With a Focus on Testosterone Therapy

  Regulatory Update

Telemedicine Prescribing of Controlled Substances in 2026:

What Clinicians Need to Know — With a Focus on Testosterone Therapy

Yoon Hang Kim, MD, MPH  |  Direct Integrative Care

MEDICAL & LEGAL DISCLAIMER

I am a physician, not an attorney. Nothing in this article constitutes legal advice. Readers who need guidance on how these rules apply to their specific practice or situation should consult a qualified health care attorney before acting.

This article is for educational and informational purposes only and does not constitute medical, legal, or regulatory advice. Federal and state laws governing the prescribing of controlled substances are complex and subject to rapid change. Clinicians should verify current requirements with the U.S. Drug Enforcement Administration (DEA), the Department of Health and Human Services (HHS), their state medical board, and qualified legal counsel before acting. Reading this article does not create a physician–patient or attorney–client relationship.

Introduction

On December 31, 2025, the U.S. Drug Enforcement Administration (DEA), together with the Department of Health and Human Services (HHS), published the Fourth Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications (90 Fed. Reg. 61301). The rule became effective January 1, 2026, and remains in effect through December 31, 2026. For clinicians who prescribe Schedule II–V controlled substances by telehealth — including testosterone for men with documented hypogonadism — the extension preserves the operational model that has been in place since March 2020, while signaling that a permanent regulatory framework is coming.

This article summarizes the current federal rules for 2026, clarifies what remains permissible via in-person, audio-video, and audio-only encounters, and applies the framework to a commonly prescribed Schedule III medication: testosterone. It closes with practical guidance for clinicians operating direct-care and telemedicine practices across multiple states, and a fully referenced bibliography.

The Legal Framework

The Ryan Haight Act Baseline

The Ryan Haight Online Pharmacy Consumer Protection Act of 2008, codified at 21 U.S.C. § 829(e) and § 802(54), generally requires that a practitioner conduct at least one in-person medical evaluation of a patient before prescribing a controlled substance by means of the internet. Once that in-person evaluation has occurred, the statute permits subsequent remote prescribing within the same practitioner–patient relationship, provided the prescriptions are issued for a legitimate medical purpose in the usual course of professional practice.

The statute also enumerates seven exceptions under 21 U.S.C. § 802(54)(A)–(G). Subsection (G) authorizes the Attorney General and the Secretary of HHS to jointly create additional telemedicine authorities by rulemaking, provided those authorities are consistent with effective controls against diversion and the public health and safety. It is this subsection that has supported every COVID-era telemedicine flexibility and every subsequent extension.

From Public Health Emergency to Fourth Temporary Extension

In March 2020, the DEA issued letters permitting practitioners to prescribe Schedule II–V controlled medications by audio-video telemedicine without a prior in-person evaluation, so long as the other requirements of the Controlled Substances Act and applicable state law were met. Beginning in May 2023, the DEA and HHS codified this flexibility through a series of temporary rules, culminating in the Fourth Temporary Extension now in effect for calendar year 2026.

The Fourth Temporary Extension amends 21 C.F.R. § 1307.41 and 42 C.F.R. § 12.1 to extend the authorization through December 31, 2026. It preserves the same substantive conditions that have applied since 2020: the prescription must be issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice; the encounter must occur using an interactive telecommunications system as defined in 42 C.F.R. § 410.78(a)(3); the practitioner must hold the appropriate DEA registration (or qualify for an exemption under 21 U.S.C. § 822(d)); and the prescription must comply with all other requirements of 21 C.F.R. part 1306.

The Two Final Rules Effective December 31, 2025

Layered on top of the temporary rule are two final rules published on January 17, 2025, and made effective on December 31, 2025 after a series of delays:

• Expansion of Buprenorphine Treatment via Telemedicine Encounter (90 Fed. Reg. 6504), codified at 21 C.F.R. § 1306.51, which authorizes prescribing of Schedule III–V narcotic medications approved by the FDA for the maintenance and withdrawal management of opioid use disorder — in practice, buprenorphine — via audio-only telemedicine in certain circumstances.

• Continuity of Care via Telemedicine for Veterans Affairs Patients (90 Fed. Reg. 6523), codified at 21 C.F.R. § 1306.52, which permits certain VA practitioners to prescribe controlled substances to veterans who have previously received an in-person evaluation from another VA clinician.

The DEA has expressly clarified that practitioners may rely on the Fourth Temporary Extension even if they also qualify under one or both final rules, because the temporary rule imposes fewer requirements. For most non-VA, non-buprenorphine practitioners, the temporary rule remains the primary authority throughout 2026.

What Is Still Coming: The Special Registration for Telemedicine

On January 17, 2025, the DEA published a Notice of Proposed Rulemaking titled Special Registrations for Telemedicine and Limited State Telemedicine Registrations (90 Fed. Reg. 6541). The proposed rule would, when finalized, create a permanent pathway for telemedicine prescribing of controlled substances without an initial in-person evaluation, but would impose new registration, recordkeeping, reporting, identity-verification, and prescription drug monitoring program (PDMP) requirements. The proposal would also restrict certain Schedule II prescribing via telemedicine and would regulate direct-to-consumer telehealth platforms as intermediaries. As of this writing, the proposed rule has not been finalized; the DEA has indicated that it intends to issue final regulations before the Fourth Temporary Extension expires at the end of 2026.

Applying the 2026 Rules to Testosterone

Testosterone Is a Schedule III Controlled Substance

Testosterone and its esters have been classified as Schedule III controlled substances under the Anabolic Steroid Control Act. As such, testosterone prescriptions are governed by the same federal telemedicine framework as other Schedule II–V medications — with the important caveat that testosterone is not a narcotic approved by the FDA for the maintenance or withdrawal management of opioid use disorder, and therefore does not qualify for the audio-only pathway that is reserved for buprenorphine.

Permissible Visit Modalities for Testosterone in 2026

The following summary applies to the initiation and continuation of testosterone therapy under federal law during the 2026 extension period. State law and standard of care may impose additional requirements.

Visit Modality	Testosterone (Schedule III)	Buprenorphine for OUD
In-person visit	Permitted	Permitted
Two-way audio-video telemedicine	Permitted (no prior in-person required)	Permitted (no prior in-person required)
Audio-only (telephone)	Not permitted	Permitted for induction and continuation

In other words, a clinician may lawfully initiate or continue testosterone therapy in 2026 via a synchronous, two-way audio-video telemedicine encounter without a prior in-person visit, provided that all other federal and state requirements are met. A telephone-only encounter is not a sufficient basis for a testosterone prescription under the current rules, because the audio-only authority is narrowly limited to buprenorphine for opioid use disorder.

Clinical Standard of Care Still Governs the Encounter

Regulatory permission to prescribe by telemedicine does not lower the clinical standard of care. The Endocrine Society's 2018 Clinical Practice Guideline, Testosterone Therapy in Men With Hypogonadism, remains the leading evidence-based reference for diagnosis and management. Its recommendations include:

• Making the diagnosis of hypogonadism only in men with both clinical symptoms or signs of testosterone deficiency and unequivocally and consistently low serum testosterone concentrations.

• Measuring fasting morning total testosterone using an accurate, CDC-standardized assay as the initial diagnostic test, and confirming the diagnosis by a second morning measurement before initiating therapy.

• Measuring free testosterone by equilibrium dialysis or an accurate calculated formula in men whose total testosterone is near the lower limit of normal or who have conditions that alter sex hormone–binding globulin.

• Distinguishing primary from secondary hypogonadism by measuring serum luteinizing hormone and follicle-stimulating hormone.

• Avoiding routine screening of the general population and avoiding routine testosterone therapy in men 65 years and older without specific indications.

• Evaluating the patient after initiation to assess response, adverse effects, and adherence, and monitoring hematocrit, prostate-specific antigen, and symptoms on an ongoing basis.

These elements should be documented in the telemedicine chart with the same rigor as in a face-to-face encounter. Clinicians operating direct-care telemedicine models should also obtain appropriate baseline laboratory studies — including complete blood count and, where indicated by age and risk, prostate-specific antigen — before initiating therapy, and should schedule interval reassessment consistent with the Endocrine Society's recommendations.

State-Level Considerations

The federal telemedicine flexibilities establish a ceiling of permissible conduct, not a floor. States may — and several do — impose stricter requirements governing the establishment of a valid practitioner–patient relationship, in-state licensure, PDMP checks, identity verification, and medical record content. Two points deserve emphasis for multi-state practices:

• The state in which the patient is physically located at the time of the encounter generally governs the standard of care, licensure, and prescribing requirements.

• In Texas, for example, prescribers must query the Texas Prescription Monitoring Program before issuing prescriptions for opioids, benzodiazepines, barbiturates, and carisoprodol; chronic pain prescribing is further governed by 22 Tex. Admin. Code Chapter 170. Testosterone is not on the Texas mandatory PMP-check list, but documentation of medical necessity, diagnosis, and monitoring remains essential.

Clinicians should confirm the current telemedicine prescribing rules in every state in which they hold licensure before relying on the federal framework alone. The Center for Connected Health Policy maintains a state-by-state policy finder that is a useful starting point, though primary verification with each state medical board is always advisable.

Practical Checklist for 2026

• Confirm DEA registration status and any state controlled-substance registrations required in each state where you prescribe.

• Use a synchronous, two-way audio-video platform that meets the interactive telecommunications system definition in 42 C.F.R. § 410.78(a)(3).

• Document a legitimate medical purpose and a thorough clinical evaluation, including diagnosis, differential considerations, and rationale for controlled substance therapy.

• For testosterone specifically: document symptoms and signs, two confirmatory fasting morning total testosterone measurements using a reliable assay, LH and FSH, and baseline safety labs.

• Perform and document the PDMP check required by the patient's state, even when not strictly mandated for the specific medication class.

• Establish a written monitoring plan and scheduled follow-up interval appropriate to the medication and patient risk profile.

• Do not rely on audio-only (telephone) encounters for controlled substances other than buprenorphine for opioid use disorder.

• Monitor DEA and HHS announcements throughout 2026 for the finalization of the Special Registration for Telemedicine rule, which is expected to impose additional compliance obligations.

Conclusion

For calendar year 2026, the federal framework for telemedicine prescribing of controlled substances remains largely unchanged from what clinicians have operated under since the COVID-19 public health emergency. Practitioners may initiate and continue testosterone therapy — and most other Schedule II–V medications — via synchronous audio-video telemedicine without a prior in-person visit, provided they comply with the legitimate-medical-purpose standard, the interactive telecommunications system requirement, applicable DEA regulations, and the law of the state in which the patient is located. Audio-only encounters remain reserved for buprenorphine in the treatment of opioid use disorder.

This is a transitional period. The DEA's proposed Special Registration for Telemedicine rule, once finalized, is expected to impose registration, recordkeeping, and platform-level requirements that will materially change workflow for direct-care and telehealth practices. Clinicians who are preparing now — by tightening documentation, aligning with published clinical guidelines, and building compliance infrastructure — will be positioned to transition smoothly when the permanent framework takes effect.

References

1. Drug Enforcement Administration, Department of Justice; Substance Abuse and Mental Health Services Administration, HHS. Fourth Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications. 90 Fed. Reg. 61301 (December 31, 2025) (to be codified at 21 C.F.R. pt. 1307 and 42 C.F.R. pt. 12). Available at: https://www.federalregister.gov/documents/2025/12/31/2025-24123

2. Ryan Haight Online Pharmacy Consumer Protection Act of 2008, Pub. L. No. 110-425, 122 Stat. 4820; codified at 21 U.S.C. § 829(e) and § 802(54).

3. Drug Enforcement Administration, HHS. Expansion of Buprenorphine Treatment via Telemedicine Encounter. 90 Fed. Reg. 6504 (January 17, 2025) (codified at 21 C.F.R. § 1306.51). Effective date delayed to December 31, 2025 (90 Fed. Reg. 13410).

4. Drug Enforcement Administration, HHS. Continuity of Care via Telemedicine for Veterans Affairs Patients. 90 Fed. Reg. 6523 (January 17, 2025) (codified at 21 C.F.R. § 1306.52). Effective December 31, 2025.

5. Drug Enforcement Administration. Special Registrations for Telemedicine and Limited State Telemedicine Registrations. Notice of Proposed Rulemaking. 90 Fed. Reg. 6541 (January 17, 2025).

6. Drug Enforcement Administration. DEA Extends Telemedicine Flexibilities to Ensure Continued Access to Care. Press Release, December 31, 2025. Available at: https://www.dea.gov/press-releases/2025/12/31/dea-extends-telemedicine-flexibilities-ensure-continued-access-care

7. U.S. Department of Health and Human Services. HHS & DEA Extend Telemedicine Flexibilities for Prescribing Controlled Medications Through 2026. Press Release, January 2, 2026. Available at: https://www.hhs.gov/press-room/dea-telemedicine-extension-2026.html

8. Bhasin S, Brito JP, Cunningham GR, Hayes FJ, Hodis HN, Matsumoto AM, Snyder PJ, Swerdloff RS, Wu FC, Yialamas MA. Testosterone Therapy in Men With Hypogonadism: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2018;103(5):1715–1744. doi:10.1210/jc.2018-00229. Available at: https://academic.oup.com/jcem/article/103/5/1715/4939465

9. Texas Medical Board. 22 Tex. Admin. Code Chapter 170 (Pain Management); Texas Health and Safety Code § 481.074, § 481.0764 (Prescription Monitoring Program check requirement).

10. Center for Connected Health Policy. Online Prescribing Policy Finder. Available at: https://www.cchpca.org/topic/online-prescribing/