Learn the legal status of ketamine and ketamine therapy under federal law, DEA Schedule III rules, FDA drug approvals, REMS mandates, and telemedicine policies.
Under federal law, ketamine is a Schedule III controlled substance (21 CFR 1308.13). We did not review state law, and a lawyer or prescriber decides for any individual. The Food and Drug Administration (FDA) approved ketamine hydrochloride injection under the brand name Ketalar as a general anesthetic agent. The agency also approved esketamine nasal spray under the brand name Spravato for specific psychiatric indications, including treatment-resistant depression in adults. Prescribers decide whether to use generic ketamine for psychiatric conditions. We found no FDA statement on that use. The most recent extension we found of the DEA telemedicine flexibilities runs through December 31, 2026, and the Ryan Haight Act otherwise requires an in-person evaluation. Review our guide to ketamine and explore Spravato vs ketamine to examine individual formulations.
This page covers federal law and FDA labeling as of October 27, 2026. State criminal codes and local health ordinances were not reviewed. This is general information. A licensed attorney answers specific legal questions, and a licensed prescriber decides treatment. A licensed attorney must evaluate specific statutory questions, and a qualified medical doctor or licensed prescriber must evaluate treatment decisions.
| Regulatory Dimension | Ketamine Injection (Ketalar) | Esketamine Nasal Spray (Spravato) |
|---|---|---|
| Controlled Substance Schedule | Schedule III depressant under 21 CFR 1308.13(c)(7), assigned DEA drug code 7285. | Schedule III controlled substance (CIII) per FDA package labeling and federal scheduling. |
| FDA Approval Status | FDA-approved general anesthetic; label lists no psychiatric indication (openFDA copy of the label, effective 2026-03-27). | Approved by the FDA under New Drug Application (NDA) 211243 on March 5, 2019. |
| Approved Label Indications | General anesthetic: sole anesthetic for diagnostic and surgical procedures not requiring skeletal muscle relaxation, induction before other general anesthetics, and a supplement to other anesthetics. | Indicated for treatment-resistant depression in adults (monotherapy or with an oral antidepressant) and depressive symptoms in MDD with acute suicidal ideation. |
| Remote Telemedicine Prescribing | Subject to 21 U.S.C. 829(e); the most recent DEA extension we found runs through December 31, 2026. | Subject to 21 U.S.C. 829(e); the most recent DEA extension we found runs through December 31, 2026. |
Ketamine is a controlled substance under federal law. Title 21 of the Code of Federal Regulations, Section 1308.13(c)(7), places ketamine, including its salts, isomers, and salts of isomers, on Schedule III of the Controlled Substances Act. The Drug Enforcement Administration assigns this chemical class drug code 7285 within the depressant category. The official package label for Ketalar confirms that ketamine is a Schedule III controlled substance under federal law.
We found no source on penalties for possession without a prescription and did not review state scheduling. State law can differ, so a licensed attorney in your state decides.
The Food and Drug Administration maintains separate regulatory approvals for ketamine and esketamine. The FDA-approved ketamine product Ketalar (ketamine hydrochloride injection) is indicated as a general anesthetic agent. The Ketalar label lists anesthesia uses (sole anesthetic for certain procedures, induction before other general anesthetics, and a supplement to other anesthetics) and no psychiatric indication.
Esketamine holds specific psychiatric approvals under the brand name Spravato. According to the FDA's Drugs@FDA regulatory record for New Drug Application (NDA) 211243, held by Janssen, the agency issued an original approval for Spravato on March 5, 2019. The original March 2019 Spravato label indicated the drug in conjunction with an oral antidepressant for the treatment of treatment-resistant depression in adults. That original label explicitly stated that Spravato is not approved as an anesthetic agent.
The FDA subsequently expanded Spravato's therapeutic scope through supplemental approvals. On July 31, 2020, the agency approved an efficacy supplement adding depressive symptoms in adults with major depressive disorder with acute suicidal ideation or behavior in conjunction with an oral antidepressant. On January 17, 2025, the FDA approved supplement S-016, expanding the indication to include monotherapy for treatment-resistant depression in adults. The current Spravato label, revised in March 2026, reflects these combined indications. For prices, see Spravato cost with insurance.
Spravato is available only through a restricted program called the SPRAVATO REMS. As specified in current package labeling, the drug is dispensed exclusively through the SPRAVATO Risk Evaluation and Mitigation Strategy (REMS).
The REMS program establishes mandatory clinical standards for facilities administering esketamine. Healthcare settings must be certified in the program. Certified healthcare settings must also ensure that each patient is monitored by a healthcare provider for at least 2 hours after administration of Spravato. For side effects, see ketamine side effects.
Remote prescribing of controlled substances is governed primarily by the Ryan Haight Online Pharmacy Consumer Protection Act. Codified at 21 U.S.C. 829(e), the statute mandates that no controlled substance may be delivered, distributed, or dispensed by means of the Internet without a valid prescription. The statute defines a valid prescription as one issued for a legitimate medical purpose in the usual course of professional practice by a practitioner who has conducted at least one in-person medical evaluation of the patient, or by a covering practitioner.
Federal authorities have modified this in-person evaluation requirement through temporary administrative rulemaking. On December 31, 2025, the Drug Enforcement Administration and the Department of Health and Human Services (HHS) published a joint fourth temporary rule in the Federal Register (90 FR 61301, Docket DEA-407). This rule issued a fourth extension of telemedicine flexibilities for prescribing controlled medications through December 31, 2026, the most recent extension we found. The text of the rule amended 21 CFR 1307.41 so that the regulatory authorization expires at the end of December 31, 2026, instead of December 31, 2025.
The notice says practitioners may, subject to certain exceptions and to DEA and state requirements, remotely prescribe controlled medications without a prior in-person evaluation. It does not mention ketamine specifically. As of late October 2026, the most recent extension we found in the Federal Register API runs through December 31, 2026. On January 17, 2025, the DEA published a proposed rule in the Federal Register titled Special Registrations for Telemedicine and Limited State Telemedicine Registrations, proposing a framework authorizing three types of Special Registrations. Comments for that proposed framework closed on March 18, 2025. The Federal Register API showed no final Special Registration rule as of October 27, 2026. Check the fourth extension notice for newer action.
Clinical therapy using generic ketamine formulations for psychiatric conditions is managed directly by licensed prescribers. Ketalar holds FDA approval strictly as a general anesthetic agent. The FDA labels for Ketalar list no psychiatric indication, and we found no FDA statement on psychiatric use of generic ketamine. A licensed prescriber decides whether it fits an individual patient.
The FDA's Compounding Risk Alerts page lists an alert dated October 10, 2023 with this title: "FDA warns patients and health care providers about potential risks associated with compounded ketamine products, including oral formulations, for the treatment of psychiatric disorders." The agency also lists an earlier alert dated February 16, 2022, concerning compounded ketamine nasal spray.
Under federal law, ketamine is a Schedule III controlled substance (21 CFR 1308.13) that licensed practitioners prescribe as Ketalar and Spravato. We did not review state law. It is classified as a Schedule III controlled substance under federal law (21 CFR 1308.13). The drug exists in two distinct regulatory categories. Ketamine hydrochloride injection (Ketalar) is FDA-approved as a general anesthetic, while esketamine nasal spray (Spravato) is FDA-approved for treatment-resistant depression and depressive symptoms in major depressive disorder with acute suicidal ideation. The Spravato label says it is available only through the SPRAVATO REMS, with certified healthcare settings and at least 2 hours of monitoring after administration.
Telehealth prescribing of controlled medications is subject to 21 U.S.C. 829(e) and to the DEA fourth temporary rule, the most recent extension we found, which runs through December 31, 2026. The notice does not mention ketamine specifically.
This legal conclusion would change if the DEA reclassifies ketamine under 21 CFR 1308 or Congress amends the Controlled Substances Act. It would also change if DEA telemedicine flexibilities expire without a final Special Registration rule, or if the FDA alters package inserts or REMS mandates. A licensed prescriber decides whether treatment fits an individual patient, and a licensed attorney answers legal questions about a specific situation.
Under federal law, ketamine is a Schedule III controlled substance (21 CFR 1308.13, DEA drug code 7285). State law was not reviewed.
Spravato (esketamine) is FDA-approved for treatment-resistant depression in adults and for depressive symptoms in adults with major depressive disorder with acute suicidal ideation or behavior, and is given under the SPRAVATO REMS. For generic ketamine used for psychiatric conditions we found no FDA statement; a licensed prescriber decides, and a licensed attorney answers legal questions.
Yes, ketamine is a Schedule III controlled substance under the Controlled Substances Act. Title 21 of the Code of Federal Regulations, Section 1308.13(c)(7), lists ketamine, its salts, isomers, and salts of isomers as Schedule III depressants under DEA drug code 7285.
Under the Ryan Haight Act (21 U.S.C. 829(e)), controlled substance prescriptions generally require at least one in-person medical evaluation. However, the DEA and HHS published a fourth temporary rule extending COVID-era telemedicine flexibilities through December 31, 2026, which is the most recent extension we found on record. This rule allows qualifying practitioners to prescribe controlled medications remotely without prior in-person examination for controlled medications generally, subject to DEA guidance and regulations and applicable federal and state law. The notice does not mention ketamine specifically. State law and DEA requirements still apply. Check the Federal Register notice for newer action.
The label says Spravato is available only through the SPRAVATO REMS (Risk Evaluation and Mitigation Strategy). Under this program, Spravato can only be administered in certified healthcare settings, and the facility must ensure that the patient is monitored by a healthcare provider for at least 2 hours after administration.
We found no FDA approval of compounded ketamine for depression in the sources we reviewed. The FDA's Compounding Risk Alerts page lists an alert dated October 10, 2023, warning patients and healthcare providers about potential risks associated with compounded ketamine products, including oral formulations, for the treatment of psychiatric disorders. The agency also lists a February 16, 2022 alert regarding compounded ketamine nasal spray.
We found no federal source covering possession of ketamine without a prescription, and state laws were not reviewed. A licensed attorney can answer for a specific situation. Under 21 CFR 1308.13, ketamine is listed in Schedule III.
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