DEA Telemedicine Special Registration Introduction

For nearly two decades, the healthcare industry has waited for the Drug Enforcement Administration (DEA) to implement the DEA telemedicine special registration process required by Congress in the Ryan Haight Online Pharmacy Consumer Protection Act of 2008. After years of delays, a proposed rule was published in January 2025. Now, the process has reached another major milestone: the DEA’s Final Rule on Special Registrations for Telemedicine and Limited State Telemedicine Registrations has been sent to the Office of Information and Regulatory Affairs (OIRA) for Executive Order 12866 review.

For telemedicine companies, healthcare providers, pharmacies, patient advocacy groups, state medical associations, and investors, this development presents a critical opportunity to influence the final shape of the rule before it is published.

The DEA Telemedicine Special Registration Rule Has Officially Reached OIRA

According to OIRA’s regulatory review dashboard, DEA’s Final Rule, RIN 1117-AB40, was received for Executive Order 12866 review on August 25, 2026. The rule remains classified as “Economically Significant,” meaning the federal government believes it could have an annual economic impact exceeding $100 million.

Importantly, OIRA’s review signals that DEA has completed much of its internal regulatory drafting and is now undergoing White House review before publication of a final rule. While changes can still occur, the process is entering its final stages. OIRA’s regulatory agenda currently anticipates final action in November 2026.

The contents of DEA’s draft Final Rule sent to OIRA are not available for public inspection, and thus it is not publicly known at this time how the draft Final Rule compares with the proposed rule that DEA published in January 2025.  The proposed rule sought to establish a permanent framework allowing certain practitioners to prescribe controlled substances via telemedicine without first conducting an in-person medical evaluation, while imposing various registration, recordkeeping, reporting, and compliance requirements. The proposed rule would also require certain direct-to-consumer telemedicine platforms to register with DEA.

What Is OIRA?

OIRA is a component of the Office of Management and Budget (OMB) within the Executive Office of the President.

Under Executive Order 12866, significant federal regulations must undergo OIRA review before becoming final. OIRA examines whether regulations are:

• Consistent with the President’s policy priorities.
• Supported by adequate legal authority.
• Cost-effective and justified by their benefits.
• Not unnecessarily burdensome on regulated industries.
• Aligned with broader federal policy objectives.

For highly significant rules, OIRA often becomes the final regulatory checkpoint before publication.

One of the most important and often underutilized aspects of OIRA review is the opportunity for outside stakeholders to request an Executive Order 12866 meeting.

These meetings allow regulated members of industry, such as healthcare providers and pharmacies, along with other interested entities, such as trade associations, patient advocacy organizations, and technology companies to present concerns, recommendations, or supporting information directly to OIRA officials while the rule is under review.

The meetings are not hearings and are not adversarial proceedings. Rather, they provide policymakers with additional information about how a proposed regulation could affect stakeholders in the real world.

OIRA publicly posts information regarding meeting requests and participants, providing a measure of transparency to the process. The pending review page for RIN 1117-AB40 includes a link to request a meeting.

Why Request an EO 12866 Meeting?

For stakeholders affected by the telemedicine special registration rule, this may be one of the last meaningful opportunities to influence federal policymakers before the final rule is issued.

An EO 12866 meeting can be used to:

Highlight Operational Challenges

Organizations can explain how proposed requirements may be implemented in practice and identify provisions that could create unintended consequences.

Examples could include:

• How the proposed rule compares with State telemedicine registration requirements.
• Whether the proposed rule properly incorporates prescription monitoring program obligations.
• Whether the proposed rule’s platform registration requirements are appropriate.
• Whether the proposed rule properly incorporates electronic prescribing requirements.
• Whether the proposed recordkeeping and reporting obligations are proper or unduly burdensome.

Present Economic Impact Data

Stakeholders can provide quantitative information concerning:

• Compliance costs.
• Technology implementation expenses.
• Staffing requirements.
• Patient access implications.
• Effects on rural healthcare delivery.

Because DEA itself has designated the rule as economically significant, economic data can be particularly influential.

Advocate for Patient Access

Many telemedicine providers serve rural, underserved, or mobility-limited populations.

Stakeholders can explain how certain provisions could:

• Improve access to care.
• Restrict access to care.
• Increase wait times.
• Reduce provider participation.

DEA’s own regulatory analysis in the proposed rule acknowledges that telemedicine prescribing can expand access to patients for whom in-person evaluations are difficult.

Recommend Alternative Approaches

Perhaps most importantly, stakeholders are not limited to commenting on proposed provisions. They can present to OIRA practical alternatives that satisfy DEA’s diversion control objectives while reducing unnecessary administrative burdens.

Timing Is Critical

Many stakeholders assume that once a Notice of Proposed Rulemaking (NPRM) comment period closes, the opportunity to influence the outcome ends.

That assumption is incorrect.

Although DEA received thousands of comments on the January 2025 proposal and has been evaluating possible alternative approaches, OIRA review remains an important stage where policymakers can consider stakeholder concerns before the final rule is published. DEA’s regulatory agenda specifically states that the agency is reviewing public comments and considering alternatives while developing the final rule.

Once OIRA completes its review and DEA publishes a final rule, opportunities to influence substantive provisions become significantly more limited.

What Telemedicine Companies Should Be Evaluating Right Now

Organizations that prescribe, dispense, or facilitate prescribing of controlled substances should closely evaluate how the final rule may affect:

• Practitioner eligibility.
• Platform registration requirements.
• Multi-state operations.
• Compliance staffing needs.
• Technology systems.
• Electronic prescribing workflows.
• Patient identity verification procedures.
• Controlled substance prescribing policies.
• Auditing and monitoring programs.

Organizations currently operating under temporary telemedicine flexibilities outlined at 21 CFR 1307.41, should not assume their future compliance obligations in the pending rule will mirror the current temporary flexibilities.

The Bottom Line

The movement of DEA’s Telemedicine Special Registration Final Rule to OIRA is one of the most significant telemedicine regulatory developments of the past several years. After nearly two decades of congressional mandates, agency rulemaking efforts, public comments, and temporary COVID-era extensions, the regulation is now entering what may be the final stage before publication.

For telemedicine providers, investors, pharmacies, health systems, professional associations, and patient advocacy organizations, an EO 12866 meeting may represent the last meaningful opportunity to explain how the regulation will affect real-world healthcare delivery.

Stakeholders who believe the proposed framework could impact patient access, provider operations, compliance burdens, or innovation in telemedicine should strongly consider whether participation in the OIRA review process is warranted.

About Brinks DEA Consulting

Brinks DEA Consulting closely monitors DEA regulatory developments and assists healthcare organizations, telemedicine platforms, law firms, and healthcare providers in evaluating proposed regulatory changes, developing compliance strategies, preparing regulatory comments, and participating in federal rulemaking processes. Our team includes former senior DEA officials with extensive experience interpreting, drafting, implementing, and enforcing controlled substance regulations.