DEA appears close to finalizing telemedicine special registration

The US Drug Enforcement Administration (DEA) submitted a final telemedicine special registration rule for review to the Office of Management and Budget’s Office of Information and Regulatory Affairs (OIRA) on August 25, 2026. While the text of the final rule is not publicly available, the update indicates that DEA may soon finalize the special registration process for telehealth prescribing of controlled substances – possibly before the current telehealth flexibilities expire on December 31, 2026. Stakeholders have eagerly awaited a telemedicine special registration since the passage of the Ryan Haight Online Pharmacy Consumer Protection Act of 2008, when it was originally required.

Background

Under the Ryan Haight Act, a telemedicine provider is required to perform an in-person medical evaluation of a patient prior to prescribing a controlled substance, with certain limited exceptions. One such exception is for providers who hold a “special registration.” The Ryan Haight Act requires the DEA to establish the circumstances and procedures under which a special registration may be issued. In the more than 16 years since the act’s passage, the DEA has failed to implement such a process, even though Congress imposed a deadline of October 2019 in the 2018 SUPPORT for Patients and Communities Act for the promulgation of final regulations.

In March 2020, in response to the COVID-19 public health emergency (PHE), the DEA invoked flexibilities that allow for prescribing controlled substances via telemedicine without an initial in-person visit. The current extension of the flexibilities authorizes all DEA-registered practitioners to prescribe Schedule II – V controlled medications via telemedicine without an initial in-person examination through December 31, 2026.

Stakeholders had hoped that the DEA would permanently adopt flexibilities for telemedicine prescribing of controlled substances after the PHE, including finally adopting a special registration process. In February 2023, the DEA and the Substance Abuse and Mental Health Services Administration proposed two rules: the general telemedicine rule and the buprenorphine rule. The two proposals would have established additional potential pathways for prescribing certain controlled substances in limited quantities via telemedicine without an initial in-person medical examination while also imposing detailed recordkeeping requirements. Notably, the proposed rules did not include a special registration process for telemedicine providers.

The DEA received a record 38,000 comments in response to the February 2023 proposed rules, including comments from federal lawmakers. Many stakeholders pointed out that the requirement for an in-person evaluation would make it more challenging for certain patients (those facing significant barriers to accessing care without telemedicine) to continue receiving the controlled medications they need. Subsequently, the DEA continued to issue temporary rules extending the telemedicine flexibilities, indicating that the extension would give the agency time to promulgate proposed and final rules on telemedicine prescribing.

In January 2025, the Biden administration released a proposed rule entitled Special Registrations for Telemedicine and Limited State Telemedicine Registrations, which addressed the long-awaited pathway for a telemedicine special registration. The proposed rule sought to establish three special registrations, creating pathways for telehealth practitioners to prescribe – and online platforms to dispense – certain controlled substances via telemedicine. The proposed rule would have imposed detailed requirements for practice standards, prescription information, and documentation, including requirements related to prescription drug monitoring program checks, use of audio-video technology, restrictions on Schedule II controlled substances, data reporting to the DEA, identity verification, clinician credentialing, and record retention. A detailed overview of the January 2025 proposed rule is available in our prior client alert.

In the current extension of the flexibilities, issued in December 2025, the DEA stated that the extension would give it time to promulgate a final set of regulations on telemedicine prescribing, as well as “allow sufficient time for providers to come into compliance with any new DEA registration, recordkeeping, or security requirements eventually adopted in a final set of regulations.”

What comes next?

Pursuant to Executive Order 12866, OIRA reviews significant draft regulations prior to public release. OIRA typically has up to 90 days to complete its review (with no minimum time for review), with the possibility of a one-time 30-day extension. Stakeholders should continue to watch for publication of the rule in the Federal Register.

As the text of the draft final rule is not yet available, it’s unknown how the draft final rule will compare to the Biden administration’s January 2025 proposed special registration rule. Regardless of the contours of the final rule, stakeholders should be prepared to quickly implement any operational changes required by the final rule.

We will continue to closely watch for developments. Please contact the authors of this article or your regular McDermott Will & Schulte lawyer with any questions.