Racemic ketamine has no FDA-approved psychiatric indication
Generic (racemic) ketamine is approved as an anesthetic agent. Its use for depression, PTSD, anxiety, chronic pain, or other psychiatric indications is off-label prescribing, which is lawful for licensed clinicians but is not the same as FDA approval for that use.
Record details
- Agency
- FDA
- Jurisdiction
- United States (federal)
- Status
- Final action
- Published
- Ongoing status
- Effective
- Not applicable / not verified
- Expires
- Not applicable / not verified
- Last checked
- August 24, 2026
Why it matters
Off-label status affects insurance coverage, the absence of a REMS framework, and the wide variation in protocols between clinics.
Primary source
FDA — Understanding unapproved use of approved drugs (off-label)
Back to the Regulatory Tracker.
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Educational use only. The content on this page is provided for general educational purposes and does not constitute medical advice, diagnosis, or treatment. Ketamine and related therapies carry risks and are appropriate only under qualified medical supervision. Always consult a licensed healthcare professional about your individual situation. Information may change as research evolves.