Understanding Ketamine Therapy and Legal Implications

Ketamine therapy is a rapidly evolving field. As its use grows, so do the legal complexities surrounding it. This article will provide a comprehensive overview of ketamine therapy, its legal status, and what providers need to consider.

What Is Ketamine Therapy?

Ketamine is a Schedule III controlled substance under the Controlled Substances Act. Originally, it was FDA approved as an anesthetic for the induction and maintenance of general anesthesia. It can be administered by intramuscular (IM) or intravenous (IV) injection in a controlled setting.

Today, ketamine is widely used off-label for psychiatric and pain-related conditions, including:

• Treatment-resistant depression

• PTSD

• Severe anxiety

• Chronic pain

  
  

Because ketamine therapy compliance involves both federal and state law, practice owners must carefully structure their services to remain compliant.

FDA Approval and Off-Label Use

Currently, the only FDA-approved ketamine-related product for mental health is Spravato® (esketamine), a nasal spray approved for treatment-resistant major depressive disorder.

Other uses of ketamine, including IV infusions, IM injections, lozenges, and compounded products, are off-label. For providers, this means:

• You cannot advertise off-label ketamine therapy as “FDA-approved.”

• You must provide clear patient disclosures explaining that these uses are not FDA-approved.

• Patients should understand the risks, benefits, and limits of ketamine therapy compliance outside of FDA-approved treatments. Written and documented informed consent is paramount.

  
  

Misrepresenting ketamine’s approval status can create exposure to claims of false advertising, patient misrepresentation, or regulatory enforcement.

Telemedicine and Compounded Products

The FDA has raised concerns about the rise of compounded ketamine products in the telemedicine space. In particular, some online platforms prescribe compounded ketamine for psychiatric disorders without proper oversight.

This creates both legal and patient safety risks. Providers should be cautious about:

• Prescribing compounded ketamine for use outside a supervised clinical setting.

• Relying on telemedicine platforms that may cut corners on compliance and monitoring.

• Advertising compounded ketamine as FDA-approved—it is not.

  
  

Because ketamine can cause sedation, dissociation, and changes in blood pressure, unsupervised use presents significant medical and legal risks for prescribers.

DEA Registration and Compliance

Because ketamine is a controlled substance, offering this therapy requires strict adherence to DEA regulations. A compliant clinic must have:

• DEA Registration: Clinics must register with the DEA (21 CFR § 1301.13).

• Secure Storage: Ketamine must be kept in a locked, permanent fixture to prevent unauthorized access (21 CFR § 1301.75(b)).

• Controlled Access: Only DEA-registered prescribers or authorized staff may handle or administer ketamine.

• Documentation & Monitoring: Accurate records of ordering, dispensing, and usage must be maintained.

  
  

Failure to meet DEA requirements for ketamine therapy can result in civil penalties, loss of DEA registration, or criminal liability.

The Importance of Compliance

Compliance is crucial when offering ketamine therapy. Providers must ensure they are following all regulations to protect themselves and their patients. This includes understanding the legal landscape and being aware of any changes in laws or regulations.

Patient Safety and Informed Consent

Patient safety is paramount in any medical treatment. When it comes to ketamine therapy, informed consent is essential. Providers should ensure that patients are fully aware of the risks and benefits associated with the treatment. This includes understanding that many uses of ketamine are off-label and not FDA-approved.

Navigating the Legal Landscape

The legal landscape surrounding ketamine therapy can be complex. Providers should seek legal counsel to navigate these waters effectively. Consulting with an experienced healthcare attorney can help ensure that your practice remains compliant and minimizes risk.

Final Thoughts

Ketamine therapy represents an exciting development in mental health and chronic pain care, but it comes with serious compliance obligations. Providers and practice owners must:

• Recognize the limits of FDA approval.

• Exercise caution with telemedicine and compounded products.

• Maintain strict DEA compliance for controlled substances.

  
  

Before adding ketamine therapy to your practice, consult with an experienced healthcare attorney to ensure your clinic is structured to minimize risk and meet all regulatory requirements.

Marti Law Group advises healthcare providers on compliance, practice structuring, and risk management in emerging treatment areas such as ketamine therapy. If you are considering offering ketamine treatments, our attorneys can help you navigate the legal landscape. Contact us today to schedule a consultation.

Frequently Asked Questions About Ketamine Therapy and the Law

Is ketamine therapy legal in the U.S.?

Yes. Ketamine is legal when prescribed and administered by a licensed healthcare provider. However, only Spravato® is FDA-approved for depression. All other uses are considered off-label and must be properly disclosed to patients.

Do I need a DEA license to offer ketamine therapy?

Yes. Because ketamine is a Schedule III controlled substance, any clinic offering it must be registered with the DEA and comply with DEA storage, access, and recordkeeping rules.

Can ketamine be prescribed through telemedicine?

The FDA has warned against compounded ketamine prescribed online without medical oversight. Providers should avoid telemedicine platforms that fail to meet compliance standards and ensure patients are supervised in a safe, clinical setting.

Is compounded ketamine safe or FDA-approved?

Compounded ketamine is not FDA-approved for psychiatric treatment. While some providers use it off-label, the FDA has warned of risks. Patients must be informed that compounded ketamine is experimental and not FDA-approved.