Dysregulated: The Patchwork Policies of Ketamine Therapy - How an off-label depression boom outpaced safety oversight and consistent rules

Ketamine therapy for depression is growing fast in the US, but the rules that govern dosing, safety procedures, and reporting are inconsistent and often minimal. The story contrasts patient experiences across locations, showing different infusion schedules, varying levels of clinical monitoring, and wide variation in aftercare and treatment plans. It notes that while ketamine related esketamine (Spravato) has an FDA safety program, regular ketamine use for depression is off-label and does not come with the same structured Risk Evaluation and Mitigation Strategy. Undark reports that for-profit IV clinics face limited oversight beyond general rules and controlled-substance requirements, with uncertainty about how to handle serious adverse event reporting. The article also discusses safety concerns such as potential addiction and organ effects from repeated use, along with proposals like a national registry that could track dosing, frequency, and harms but may be difficult to implement without restricting access.