U.S. federal and state authorities are intensifying oversight of ketamine sales and prescribing practices amid growing concerns over the drug’s increasing use outside traditional medical settings. The Drug Enforcement Administration (DEA) and Food and Drug Administration (FDA) have recently targeted numerous websites offering ketamine in various forms—vials, powders, nasal sprays, and lozenges known as “troches”—often with minimal regulation or medical supervision.
The FDA issued warning letters to several online sellers, emphasizing that ketamine’s potency and associated risks require administration strictly under the supervision of licensed healthcare providers. Ketamine has gained prominence as a psychiatric treatment for depression, anxiety, and other mental health conditions, with some telehealth companies facilitating prescriptions for at-home use. However, some platforms allegedly dispense the drug without a prescription, raising safety alarms.
The recent focus on ketamine regulation is prompted in part by reports of adverse outcomes linked to unsupervised use. The American Society of Anesthesiologists highlighted the death of a 41-year-old woman in New York, calling on policymakers to address the rapid expansion of home-delivered ketamine. Many mental health professionals and regulators worry that unsupervised at-home use could lead to overdose, misuse, or other medical emergencies.
The Texas Medical Board has proposed banning the at-home use of injectable ketamine, citing the potential for sudden complications that require immediate medical intervention. This proposed restriction would not extend to ketamine lozenges, which are the form most commonly prescribed by telehealth providers. Nonetheless, the board stated it will investigate any complaints concerning ketamine administration, regardless of delivery method, and has suggested enhancing training requirements for physicians who prescribe the drug.
Ketamine has a long history of medical use as an anesthetic in hospitals and is also known as a recreational street drug. Over the past decade, clinical research and growing demand have contributed to the emergence of clinics offering ketamine as a psychiatric treatment. During the COVID-19 pandemic, federal authorities temporarily relaxed rules to permit remote prescribing of controlled substances, including ketamine, without the usual requirement for an initial in-person visit. This policy has been extended multiple times and is currently under review for possible continuation beyond its expiration at year-end.
Proponents of telehealth-based ketamine treatment argue that home use can be transformational for patients with treatment-resistant depression. However, some clinicians caution that dosing regimens—often involving lozenges taken one to three times weekly—may leave patients impaired for extended periods. Reports from patients and psychiatrists suggest that refills can sometimes be obtained with minimal oversight, facilitated by online questionnaires or message exchanges.
Dr. Sandhya Prashad, president of the American Society of Ketamine Physicians, Psychotherapists & Practitioners and a psychiatrist practicing in Texas, raised concerns about some companies administering high doses of ketamine remotely. She noted the absence of published research validating the safety or efficacy of such dosing strategies. According to Dr. Prashad, in-person treatment remains critical for monitoring patient responses and vital signs, such as blood pressure, to ensure safe ketamine use.
State regulation of ketamine is evolving quickly, with Texas’s actions drawing attention nationwide. While some patients may transition to take-home ketamine as part of a structured and supervised treatment plan, experts emphasize the importance of careful medical oversight to mitigate risks associated with unsupervised use.