Do Doctors Need a DEA Registration to Legally Prescribe Ketamine?

Ketamine Therapy is a Controlled Substance Under Federal Law

Physicians Must Comply with the Same DEA and Controlled Substances Act Requirements When Prescribing Ketamine as When Prescribing Any Other Controlled Substance.

The use of ketamine therapy to treat depression and other mental health disorders is rapidly gaining popularity in the United States. While clinical trials are lacking, numerous studies have shown that ketamine therapy can be effective for treating a variety of mental health conditions.

But, when it comes to ketamine therapy, doctors need to be very careful.

The United States Drug Enforcement Administration (DEA) is actively targeting healthcare providers that violate the Controlled Substances Act’s registration and prescribing requirements.

Doctors Must Register with the DEA in Order to Legally Prescribe Ketamine

Ketamine therapy is a powerful drug. Under the Controlled Substances Act, it is classified as a Schedule III controlled substance. Schedule III drugs are those that have “a potential for abuse less than drugs or other substances in schedules I and II,” and that have “a currently accepted medical use in treatment in the United States.”

Since ketamine is a controlled substance, all of the Controlled Substances Act’s requirements apply to prescribing it to patients. This includes the requirements to obtain and maintain DEA registration.

“Every person who manufactures, distributes, dispenses, imports, or exports any controlled substance or who proposes to engage in the manufacture, distribution, dispensing, importation or exportation of any controlled substance shall obtain a registration unless exempted by law.”

Doctors can register online using DEA Form 224 (assuming they are not already registered to prescribe other controlled substances).

DEA Registration Requirements

• Maintaining detailed and accurate records of all ketamine prescriptions
• Taking an “exact inventory of all stocks thereof on hand” at least every two years
• Implementing appropriate security measures to prevent diversion
• Complying with all applicable reporting requirements

At Spodek Law Group, we help healthcare providers navigate the complexities of DEA registration and ketamine therapy compliance. Contact us at 908-643-7005 for a consultation.