Ketamine Regulatory Tracker: FDA, DEA & Telehealth Rules
Ketamine care sits at the intersection of an approved anesthetic, an off-label psychiatric practice, one FDA-approved nasal spray, and controlled-substance law. This tracker keeps those threads separate and sourced.
Tracked actions
- FDAFinal actionLast checked: August 24, 2026FDA approves Spravato (esketamine) nasal spray for treatment-resistant depressionThe FDA approved esketamine nasal spray, marketed as Spravato, for treatment-resistant depression in adults, to be used together with an oral antidepressant. Approval came with a Risk Evaluation and Mitigation Strategy (REMS) requiring administration in a certified healthcare setting with post-dose monitoring.
- FDAFinal actionLast checked: August 24, 2026FDA expands Spravato label to depressive symptoms in adults with acute suicidal ideation or behaviorThe FDA approved a supplemental indication for Spravato covering depressive symptoms in adults with major depressive disorder who have acute suicidal ideation or behavior, used alongside an oral antidepressant. The approval did not establish that esketamine prevents suicide.
- FDAFinal actionLast checked: August 24, 2026FDA approves Spravato as a standalone (monotherapy) treatment for treatment-resistant depressionThe FDA approved esketamine nasal spray for use without a concurrent oral antidepressant in adults with treatment-resistant depression. REMS certification and in-clinic monitoring requirements continue to apply.
- DEAFinal actionLast checked: August 24, 2026Ketamine is a Schedule III controlled substance under federal lawKetamine is listed in Schedule III of the Controlled Substances Act. Prescribing, dispensing, recordkeeping, and storage are subject to DEA registration requirements, and state controlled-substance rules apply in addition to federal ones.
- FDAGuidance / alertLast checked: August 24, 2026FDA warns about risks of compounded ketamine products for at-home useThe FDA issued a safety alert regarding compounded ketamine products — including oral formulations marketed through telemedicine platforms for at-home use — noting that compounded drugs are not FDA-approved, that sedation and dissociation can occur without monitoring, and that psychiatric and urinary adverse events have been reported.
- DEAVerify current statusLast checked: August 24, 2026Telemedicine prescribing of controlled substances: pandemic-era flexibilities and their extensionsDEA, together with HHS, permitted prescribing of certain controlled substances via telemedicine without a prior in-person evaluation, and extended those flexibilities through a series of temporary rules while permanent rulemaking remained under consideration. Because these rules have been repeatedly extended and amended, Ketalux does not assert a current expiration date.
- FDAFinal actionLast checked: August 24, 2026Racemic ketamine has no FDA-approved psychiatric indicationGeneric (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.
How this tracker is maintained
Each record links to a primary government source. Where the present-day status of a rule cannot be confirmed — as with the repeatedly extended telemedicine prescribing flexibilities — the record says so instead of stating a date we cannot stand behind. See our methodology and editorial independence policy.
Related reading: esketamine (Spravato), at-home ketamine programs, clinical trials tracker, and the Safety Center.
Independent publisher and editor of Ketalux, based in Chicago, Illinois. Ira commissions, edits, and reviews every article on the site and believes ketamine therapy — used responsibly — offers real hope for people living with depression, anxiety, PTSD, and chronic pain. Contact: ira@idigits.com.
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.