The Regulatory Landscape
The prescribing of controlled substances via telehealth has been one of the most closely watched regulatory issues in healthcare since the COVID-19 pandemic. For ketamine patients and providers, the rules governing whether a physician can prescribe a Schedule III controlled substance through a video consultation — without an in-person examination — have shifted repeatedly since 2020, creating uncertainty across the treatment landscape.
The core tension centers on the Ryan Haight Online Pharmacy Consumer Protection Act of 2008, which requires an in-person medical evaluation before a practitioner may prescribe controlled substances via telemedicine. The law was designed to prevent illegal online pharmacies from distributing controlled drugs without legitimate medical oversight. However, it was enacted before the explosion of legitimate telehealth services and before ketamine emerged as a widely used psychiatric treatment.
COVID-Era Flexibilities
When the COVID-19 public health emergency (PHE) was declared in March 2020, the DEA exercised enforcement discretion to temporarily waive the Ryan Haight Act's in-person requirement. This allowed practitioners to prescribe controlled substances, including ketamine, based solely on telehealth evaluations. The flexibilities enabled the rapid expansion of at-home ketamine treatment programs, where patients consult with prescribers via video and receive compounded ketamine formulations shipped from compounding pharmacies. For a broader look at this growing sector, see our overview of at-home ketamine companies.
These temporary flexibilities were extended multiple times as the PHE continued and as the DEA worked to develop permanent rules. The public health emergency officially ended in May 2023, but the DEA continued extending telehealth prescribing flexibilities through a series of temporary rules while the permanent regulatory framework was developed.
The 2024 Proposed Rules
In early 2024, the DEA published proposed rules that would have created a two-tiered system for telehealth prescribing of controlled substances. Under the proposal, practitioners could prescribe up to a 30-day initial supply of Schedule III through V controlled substances based on a telehealth evaluation alone. To continue prescribing beyond 30 days, an in-person evaluation would be required — either by the prescribing practitioner or by a referring practitioner who conducted an in-person exam.
The proposal generated more than 38,000 public comments, with substantial input from patients, providers, advocacy organizations, and the telehealth industry. Many commenters argued that the 30-day limit was insufficient for ketamine therapy, which often requires ongoing prescriptions over months of treatment. Others expressed concern that requiring in-person visits would eliminate access for patients in rural areas or those with mobility limitations.
What Changed in 2025
After extensive public input and multiple extensions of the temporary flexibilities, the DEA finalized updated telehealth prescribing rules that took effect in 2025. The key provisions affecting ketamine prescribing include:
Initial prescribing via telehealth: Practitioners may prescribe Schedule III through V controlled substances for an initial period based on a telehealth evaluation, provided the evaluation meets established standards of care and is conducted via real-time audio-visual communication (not audio-only for the initial encounter).
In-person evaluation timeline: For ongoing prescriptions beyond the initial period, patients must complete an in-person evaluation. The rules allow this evaluation to be conducted by the prescribing practitioner, a referring practitioner, or a qualified healthcare professional designated by the prescriber. The specific timeline and requirements are subject to state-level implementation.
State-level variability: The final rules acknowledge that states retain authority to impose additional restrictions on telehealth prescribing of controlled substances. Several states have enacted their own requirements that go beyond the federal minimums, including shorter initial prescribing windows, mandatory in-person evaluations at defined intervals, or limitations on which practitioner types may prescribe ketamine via telehealth.
DEA registration requirements: The rules clarify that practitioners prescribing controlled substances via telehealth must hold a DEA registration in the state where the patient is located at the time of the encounter, or must meet specific exceptions. This requirement has implications for multi-state telehealth practices.
Impact on Ketamine Patients
For patients currently receiving or considering ketamine therapy, the 2025 rules have several practical implications:
Continued access: The finalized rules preserve the ability to initiate ketamine treatment through telehealth, which is how the majority of at-home oral and sublingual ketamine programs operate. Patients who relied on pandemic-era flexibilities will not lose access abruptly.
In-person visit requirement: Patients will need to plan for an in-person evaluation as part of their ongoing treatment. For patients in areas with limited provider availability, this may require travel or coordination with local healthcare providers who can conduct the required examination.
Provider compliance: Patients should verify that their prescribing provider is aware of and compliant with the current federal and state-specific telehealth prescribing regulations. Providers who are not in compliance risk DEA enforcement action, which could disrupt patient care.
Documentation standards: The rules emphasize that telehealth prescribing of controlled substances must meet the same standard of care as in-person prescribing. This includes thorough psychiatric evaluation, documentation of medical necessity, monitoring for side effects and misuse, and appropriate follow-up.
Looking Ahead
The regulatory environment for telehealth prescribing of controlled substances continues to evolve. Congressional action, DEA rulemaking, and state-level legislation all contribute to an ongoing process of balancing patient access against controlled substance safety. Patients and providers should stay informed about current requirements through the DEA's Diversion Control Division and their state board of pharmacy.
The broader trend appears to be toward accommodation of telehealth within a framework of appropriate safeguards, reflecting the reality that telehealth has become a permanent fixture of healthcare delivery. For ketamine therapy specifically, the resolution of telehealth prescribing rules is closely watched because it directly determines how — and whether — millions of patients with treatment-resistant depression can access this treatment. For details on state-level regulatory variation, see our companion article.
References
- DEA Telehealth Prescribing Regulations — DEA rulemaking documents on controlled substance telehealth prescribing.
- Ryan Haight Online Pharmacy Consumer Protection Act — Full text of the federal law governing online controlled substance prescribing.
- Congressional Research Service: Telehealth and Controlled Substances — CRS analysis of the regulatory framework.
- SAMHSA Telehealth Guidance — Substance Abuse and Mental Health Services Administration telehealth resources.
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