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Ketamine Went From Psychiatry’s Great Hope to a Regulatory Reckoning, and 2026 Is the Shakeout. The Only FDA-Approved Version Sits Behind a Locked Door; Everything Else Is Off-Label.

Ketamine Went From Psychiatry’s Great Hope to a Regulatory Reckoning, and 2026 Is the Shakeout. The Only FDA-Approved Version Sits Behind a Locked Door; Everything Else Is Off-Label.

by Ethan Webb | Aug 26, 2026 | Regulation

FDA enforcement, a wrongful-death suit, and an expiring telehealth rule are converging on a ketamine industry that scaled far faster than its safeguards. Key TakeawaysOne approved product, a vast off-label market: Only esketamine (Spravato) is FDA-approved for...

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