The Telehealth Ketamine Boom

During the COVID-19 pandemic, emergency regulatory flexibilities allowed providers to prescribe controlled substances — including ketamine — via telehealth without an initial in-person evaluation. This created an opening for a new category of companies offering oral and sublingual ketamine prescribed through virtual consultations and shipped directly to patients.

The model grew rapidly. Companies like Mindbloom, Joyous, and others attracted hundreds of thousands of patients, many of whom had never been able to access ketamine therapy through traditional in-clinic routes. However, the rapid scaling also raised concerns about patient safety and appropriate oversight.

Why Regulators Are Concerned

Several factors have driven increased regulatory scrutiny:

Safety Reports

  • The FDA received reports of adverse events associated with compounded ketamine used without adequate supervision, including cases resulting in hospitalization and death
  • In October 2023, the FDA issued a formal safety communication warning healthcare providers and patients about the risks of compounded ketamine products, particularly when used outside supervised medical settings

Prescribing Standards

  • Concerns that some telehealth platforms conducted brief evaluations (sometimes under 30 minutes) before prescribing a controlled dissociative substance
  • Questions about adequate follow-up, with some models relying primarily on asynchronous messaging rather than regular clinical assessments
  • Variability in screening for contraindications (cardiovascular risk, psychosis history, substance use disorders)

DEA Scheduling Considerations

  • Ketamine is a Schedule III controlled substance under the Controlled Substances Act
  • As pandemic-era telehealth flexibilities expire, the DEA has been working to establish permanent rules for telehealth prescribing of controlled substances
  • The proposed rules would require at least one in-person evaluation before telehealth prescribing of controlled substances in most circumstances

Key Regulatory Developments

FDA Safety Communication (October 2023)

The FDA's alert specifically addressed compounded ketamine products and highlighted that these are not FDA-approved, have not been evaluated for safety and efficacy, and lack the quality controls of commercially manufactured medications. The communication was not a ban but rather a warning to both patients and providers.

DEA Telehealth Prescribing Rules

The DEA has proposed regulations that would:

  • Require an initial in-person medical evaluation before prescribing Schedule III-V controlled substances via telehealth (with limited exceptions)
  • Allow subsequent prescriptions to be managed via telehealth after the initial in-person visit
  • The timeline for final implementation has been extended multiple times, and the rules continue to evolve

State-Level Action

Several states have implemented or proposed their own regulations, including:

  • Requirements for in-person evaluations before ketamine prescribing
  • Mandated monitoring protocols for at-home ketamine use
  • Specific documentation requirements for off-label controlled substance prescribing

What This Means for Patients

If you are currently using or considering telehealth ketamine services:

  • Your current treatment may not be affected immediately, but regulations could change how your provider operates in the future
  • Ask your provider about their compliance plans for upcoming regulatory changes
  • Ensure your provider conducts a thorough evaluation — not just a brief screening — before prescribing
  • Have a safety plan: Know what to do if you experience an adverse reaction during at-home use
  • Consider in-clinic options if they are accessible to you, as they provide a higher level of medical oversight

What This Means for Providers

Clinicians offering ketamine via telehealth should:

  • Stay current with both federal (DEA, FDA) and state-level regulatory changes
  • Document thorough evaluations, informed consent, and ongoing monitoring
  • Follow professional organization guidelines (ASKP3, APA) for ketamine prescribing standards
  • Consider hybrid models that combine in-person evaluation with telehealth follow-up

The Path Forward

The goal of regulation is not to eliminate access to ketamine therapy but to ensure it is delivered safely. The challenge for policymakers is balancing patient access — particularly for those in underserved areas — with appropriate safeguards. As the regulatory landscape continues to develop, both patients and providers should stay informed and prioritize safety above convenience.

This article reflects the regulatory situation as of early 2025 and is for informational purposes only. Regulations are actively evolving; consult current federal and state resources for the latest information.