What Should I Do if the DEA is Investigating My Ketamine Prescription Practices?

The U.S. Drug Enforcement Administration (DEA) has recently begun taking a closer look at ketamine clinics in the United States. These are clinics that provide ketamine therapy, also called ketamine infusion therapy, which involves the use of small doses of ketamine to treat anxiety disorders, depression, addiction, post-traumatic stress disorder, pain management, and other medical conditions. One of the primary reasons for the DEA’s focus on ketamine clinics is the fact that the use of ketamine for the treatment of these conditions is currently unapproved by the U.S. Food and Drug Administration (FDA).

As a result, while ketamine clinics are legal, they are subject to some very important restrictions. For example, the U.S. Controlled Substances Act (CSA) includes various restrictions on the off-label use of ketamine for “general medical practice.” Ketamine clinics must be extremely careful to avoid running afoul of these restrictions, as any violation of the CSA or other federal laws could lead to a DEA investigation.

If your ketamine clinic is DEA registered and you are facing a federal investigation, you need to speak with an experienced federal defense lawyer right away. Even if you believe that your clinic is in full compliance with all applicable laws, you must take appropriate steps to determine why the DEA is targeting your clinic, and you must develop a comprehensive and cohesive defense strategy.

Potential Allegations Against Ketamine Clinics During DEA Investigations

All remanufacturer, distributor, and dispensary facilities that are DEA registered are subject to the DEA’s jurisdiction. This includes ketamine clinics. With the DEA’s recent focus on ketamine clinics, ketamine clinic owners and operators must prioritize compliance, and they must be prepared to respond proactively in the event of a DEA investigation.

There are several potential allegations that could arise from a DEA investigation of a ketamine clinic. These include (but are not limited to):

Unlawful Distribution of Ketamine

As noted above, the FDA has only approved ketamine for use as a general anesthetic. However, the FDA’s approval of ketamine for use as a general anesthetic does not prohibit doctors from prescribing it for off-label use. In fact, doctors routinely prescribe medications for off-label use. However, in order to prescribe ketamine (or other drugs) for off-label use, doctors must still comply with all other federal laws and regulations that apply to their practices.

For example, under the CSA, ketamine is considered a Schedule III controlled substance. This means that it has “a moderate to low potential for physical and psychological dependence.” To schedule a substance under one of the CSA’s five schedules, the DEA considers the drug’s “potential for abuse,” among other factors. In this particular case, the DEA determined that ketamine’s potential for abuse warranted its classification as a Schedule III controlled substance.

As a result, while prescribing ketamine for off-label use is not illegal, it is subject to strict limits under the CSA. This is true for both physicians who prescribe ketamine and clinics that dispense it.

Ketamine Diversion

One of the main risks with regard to the administration of ketamine in a clinical setting is the risk of diversion. Ketamine diversion can take various different forms, from patients selling ketamine they obtain from their clinics to clinics selling ketamine to unauthorized buyers. While both of these forms of diversion entail equal risk, they both present risks for clinics and physicians as well.

Ketamine Drug Trafficking

In cases involving allegations of high-volume diversion, the DEA may allege that a ketamine clinic is engaged in drug trafficking. Drug trafficking is an extremely serious allegation that can trigger an array of other federal charges.

Illegal Prescription Drug Marketing

Illegal prescription drug marketing is another potential allegation in DEA investigations targeting ketamine clinics. This offense involves exchanging compensation for referrals or payment information, and it is prohibited under Section 7(b) of the federal Anti-Kickback Statute.

Failure to Conduct Appropriate Ketamine-Related Due Diligence

Another potential allegation in DEA investigations of ketamine clinics is the failure to conduct appropriate due diligence related to the use of ketamine. Since ketamine is currently only indicated for general anesthesia, the DEA expects that physicians will only prescribe and administer the drug when absolutely necessary.