Ketamine and its Regulatory Implications: A Review
Journal of Medical Regulation December 1, 2025 Amol Soin, Y.c. Janardhan Reddy, Kris Ferguson et al.
Ketamine, an NMDA receptor antagonist approved as an anesthetic since 1970, is increasingly used off-label at subanesthetic doses for depression and other conditions, despite risks of dissociative, psychomimetic, and hemodynamic symptoms. The rise of largely unregulated ketamine clinics, sometimes using compounded formulations, poses patient safety concerns. The article reviews ketamine's pharmacology and evidence for off-label use, and suggests regulatory measures for clinics, compounding pharmacies, and providers.