While ketamine has been used as an anesthetic for decades, doctors are increasingly prescribing the drug as an off-label option for treating depression and other mental health conditions. But, is this legal?
In short, yes. Doctors can legally prescribe ketamine for off-label use; but, like all medications, ketamine requires a prescription from a licensed healthcare provider. The U.S. Food and Drug Administration (FDA) has approved one ketamine-based medication (Spravato) for use as an antidepressant, and doctors can prescribe generic or compounded ketamine for off-label use as well.
However, Ketamine Prescriptions Must Comply With Federal and State Law
While it is legal for doctors to prescribe ketamine off-label, the prescribing and dispensing of the drug must comply with both federal and state law. As a Schedule III controlled substance, ketamine is subject to monitoring by the U.S. Drug Enforcement Administration (DEA), and the DEA will take enforcement action against doctors, pharmacies, and clinics that fail to comply with the Controlled Substances Act (CSA).
Federal Oversight of Ketamine Prescriptions
The CSA governs the prescribing and dispensing of all controlled substances, including ketamine. Under the CSA, ketamine is subject to prescription, recordkeeping, and reporting requirements. When prescribing ketamine, doctors must also ensure that their patients are suitable candidates for ketamine therapy.
State Oversight of Ketamine Prescriptions
States have the authority to regulate the prescribing and dispensing of ketamine as well. In many cases, state laws add to the requirements that doctors, pharmacies, and clinics must meet under the CSA.
State Medical Board Oversight of Ketamine Prescriptions
Beyond statutory requirements and licensing requirements for ketamine clinics, doctors who prescribe ketamine off-label also face oversight from their state medical licensing boards.
Mitigating the Risk of Medical Board Scrutiny When Prescribing Ketamine
- Adopt and Implement Ketamine Therapy Protocols
- Maintain Detailed Patient Records
- Conduct Routine Compliance Audits
Ketamine Therapy Compliance for Doctors, Pharmacies, and Clinics
At Spodek Law Group, we work with doctors, pharmacies, and clinics to help them legally prescribe, dispense, and administer ketamine. To learn more about our ketamine therapy compliance services, contact us today for a complimentary consultation.
Contact Spodek Law Group. To discuss your compliance needs regarding ketamine therapy, call our legal team at 908-643-7005.
Written By
Todd Spodek
Todd Spodek is the Managing Partner of Spodek Law Group P.C. He is a second-generation trial attorney who has been recognized as one of the Top 100 Trial Lawyers in the country. He has represented clients in some of the highest-profile federal criminal cases in the Eastern District of Pennsylvania and beyond.
