DEA Compliance Risks for Ketamine Clinics and Providers

As ketamine gains popularity for a variety of therapeutic uses, medical providers are increasingly turning to this compound as an alternative to traditional pharmaceuticals. Ketamine is a Schedule III controlled substance that the U.S. Food and Drug Administration (FDA) has approved for use as an anesthetic. However, while ketamine is not FDA-approved for use as an analgesic or to treat depression, anxiety, and various other conditions, use of ketamine to treat these conditions is on the rise.

This, in turn, has led to inquiries, audits, and investigations by the Drug Enforcement Administration (DEA).

With this in mind, if you are a medical provider that prescribes or administers ketamine, you need to be extremely cautious. From DEA compliance to FDA approval, there are numerous issues that can get medical providers into trouble when utilizing controlled substances to treat patients. If you are not careful, you could be at risk for facing fines, loss of DEA registration, and other administrative penalties. In some cases, providers can face criminal prosecution, and the penalties for illegally prescribing or distributing controlled substances can be severe.

Off-Label Ketamine Use

As we mentioned above, the FDA has not approved ketamine for use as an analgesic or to treat depression, anxiety, and various other conditions. This means that these uses are considered “off-label.”

Off-label drug use is generally legal; and, according to a 2006 article in the New England Journal of Medicine, “approximately one of five prescriptions written today are for off-label use.” But, medical providers that prescribe drugs off-label must still comply with all applicable prescribing rules and regulations. For controlled substances like ketamine, this means that providers must also comply with all applicable DEA regulations (on top of obtaining DEA registration).

DEA Compliance for Ketamine Clinics

The DEA’s regulations apply to all registered providers with the authority to prescribe controlled substances. However, with the FDA having not approved ketamine for certain uses, when prescribing ketamine for these off-label uses, providers need to be especially careful to ensure compliance.

For example, let’s assume that you run a ketamine clinic and provide ketamine infusions to patients suffering from depression. Under the DEA’s regulations, you have a “corresponding responsibility” to prescribe controlled substances like ketamine, “only for a legitimate medical purpose . . . acting in the usual course of . . . professional practice.” This is a very high standard, and while it isn’t explicitly defined, there are several factors that the DEA will look at when determining whether providing ketamine infusions to your patients is a legitimate use of the drug.

These factors include:

• The Frequency of Your Ketamine Prescriptions – How often are you prescribing ketamine to your patients? In the DEA’s view, when a patient has a legitimate need for a controlled substance, that patient’s need is typically short-term.
• The Dosage of Your Ketamine Prescriptions – Are you prescribing ketamine in medically-appropriate dosages? If you are over-prescribing, you can expect to receive a visit from the DEA.
• The Duration of Your Ketamine Courses – Similar to the frequency issue, if you are prescribing a high volume of ketamine over a long period of time, this is going to raise questions as to whether your patients’ needs are actually legitimate.
• Your Reasons for Prescribing Ketamine – Why are you prescribing ketamine? The DEA is extremely skeptical of the use of controlled substances – especially when the FDA has not approved their use for a particular purpose.
• Your Assessment of Your Patients’ Needs – What steps are you taking to ensure that your patients’ needs are legitimate?
• Your Efforts to Prevent Diversion – What measures are you utilizing to prevent diversion? Are you maintaining comprehensive records of your ketamine prescriptions?

These are just some of the primary factors that the DEA considers when determining whether a provider’s prescription practices are legitimate.

DEA Investigations of Medical Providers that Prescribe and Administer Ketamine

Given the risks involved, if you are a medical provider that prescribes or administers ketamine, you need to prioritize compliance. You also need to be prepared to defend yourself if necessary.

We recently saw this in the case of Mathew Perry. The DEA accused Perry’s doctor of prescribing “a massive dose of ketamine,” even though “all the evidence points to the amount in his body that killed him was all self-administered by [Perry] during the final hours of his life, and not through a ketamine infusion.” The DEA’s investigation reportedly focused “on whether Perry had a prescription for the ketamine that was in his system at the time of his death and whether his doctor’s actions constitute a federal offense.”

While this case is a bit unusual in that it involves a celebrity, it is not unusual in virtually any other respect. The DEA regularly investigates and charges medical providers with violating the Controlled Substances Act (CSA) and other laws that apply to prescription drug dispensing and administration.

Protect Your Practice and Your Reputation from DEA Allegations

With all of this in mind, if you prescribe or administer ketamine, you need to take the necessary steps to protect your practice and your professional reputation from DEA allegations. This includes not only maintaining DEA compliance, but also being prepared to defend yourself in the event of a DEA inquiry, audit, or investigation.

At Spodek Law Group, we have extensive experience on both sides of DEA enforcement matters involving Schedule III drugs. If you are a medical provider that prescribes and administers ketamine, our legal team can work with you to develop an appropriate compliance program; and, if you are facing scrutiny from the DEA, we can advise you regarding the steps you need to take to protect yourself.

Schedule an Appointment at Spodek Law Group

To speak with our attorneys at Spodek Law Group about DEA compliance or defense, please call 212-300-5196 or contact us online.