Legal Considerations for Ketamine Practitioners in Virginia

The popularity of ketamine as a potential treatment for mental health issues such as depression, anxiety, post-traumatic stress disorder (PTSD), and obsessive-compulsive disorder has exploded in recent years. Unlike marijuana and other psychedelics such as psilocybin and MDMA, ketamine is an FDA-approved drug. However, the use of ketamine to treat mental-health disorders is considered “off-label” and not without its risks, including risks related to advertising such services. In this blog post we discuss why Virginia health practitioners should exercise caution before advertising their ketamine services.   

I.Background  

Ketamine is a psychoactive drug with a history of both recreational and medical use. It is a Schedule III substance on the Federal Controlled Substances Act and the Virginia Drug Control Act. Schedule III is reserved for substances that (1) have a potential for abuse less than the substances listed in Schedules I and II; (2) have a currently accepted medical use in treatment in the United States; and (3) abuse of the substance may lead to moderate or low physical dependence or high psychological dependence. Va. Code § 54.1-3449.  

In order to lawfully handle Schedule III substances, a practitioner must be registered with both the DEA and the Virginia Board of Pharmacy.   

While ketamine is FDA-approved, its only FDA approved uses are as an anesthetic during diagnostic and surgical procedures. All other uses of ketamine, including for mental health purposes, are considered “off-label,” as in, a use for which the drug was not originally approved. This is not unlawful; once a drug has been approved by FDA, a healthcare provider may prescribe the drug for an off-label use if they deem it medically appropriate for their patient. FDA approves drugs, it does not regulate healthcare providers.  

  Off-label use of drugs is subject to certain advertising limitations, however. Virginia healthcare providers must be aware of these limitations before publicly advertising their therapeutic ketamine services.   

II.Advertising Restrictions for Off-Label Use  

The Federal Food Drug and Cosmetic Act (“FDCA”) makes it unlawful to distribute drugs that are misbranded. 21 U.S.C. § 331(a). A drug is considered “misbranded” if its “labeling” is false or misleading. 21 U.S.C. § 352(a)(1). Importantly, “labeling” is defined as “all labels and other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such article.” 21 USCA § 321(m) (emphasis added).  Because a label is defined broadly to include written, printed, or graphic matter accompanying a drug, drug manufacturers and healthcare providers must be careful when promoting an off-label use of a drug, as such promotion may be considered “misbranding” under the FDCA.   

Because drug manufacturers are typically responsible for labeling of drugs, violations of the prohibition on promoting off-label uses are often charged against drug manufacturers. However, doctors may also be found in certain circumstances to be improperly engaging in promotional activities toward off-label uses of specific medications, such as ketamine. Physicians may discuss off-label use directly with their patients, but when a physician or healthcare provider begins making public statements about an off-label use, they run a risk of violating the prohibitions on misbranding of drugs.   

III. Dealing with a Board Investigation in Virginia  

If you are a Virginia healthcare provider prescribing ketamine off-label, please keep in mind the various risks of working in this space and advertising such services. We are aware of instances where providers have been investigated by the Virginia Department of Health Professions (DHP) triggered by their online advertisements of ketamine services. In one notable case, the DHP launched an investigation into a provider that required the disclosure of extensive patient and financial records. Our firm worked closely with the provider, helping them navigate the complex regulatory landscape, and the investigation was ultimately dismissed.  

As the use of ketamine therapy continues to evolve, particularly in the context of mental health treatment, we have seen a rise in innovative therapeutic approaches. These approaches often integrate group therapy sessions aimed at reaching altered states of consciousness, combining ketamine administration with elements of poetry, dance, artistic expression, song, and other ceremonial aspects. These integrative models are proving to be highly effective and are rapidly establishing a new standard of care across the country.  

However, alongside these advancements, we have identified the presence of bad actors in the field—individuals or entities that exploit the therapeutic potential of ketamine by overprescribing without the necessary integrative frameworks. These so-called “modern pill mills” operate with little regard for patient well-being, focusing instead on profit. Their practices undermine the legitimate advancements in ketamine therapy and expose themselves to scrutiny under both Virginia and federal law.  

At Holon Law Partners, we strive to distinguish between those medical professionals who are adhering to emerging best practices and those who are engaging in noncompliant, profit-driven behavior. By advocating for compliance with both Commonwealth and federal regulations, we help ensure that the right providers are protected under the law.  

If your practice incorporates innovative, therapeutic models or if you are concerned about compliance risks in this new world of mental health, our firm is here to provide comprehensive legal support.