Ketamine and Telehealth: What the Federal and State Rules Require

Ketamine programs come in three shapes: in-clinic IV infusion, esketamine nasal spray in a certified office, and compounded ketamine (usually oral or sublingual) prescribed by video and taken at home. Telehealth touches all three, but the rules land hardest on the third. Before designing a ketamine service line, an operator needs four facts straight.

What is ketamine's regulatory status?

• Schedule III. Ketamine is a Schedule III controlled substance under 21 CFR 1308.13(c). Prescribers need a DEA registration covering Schedule III in the patient's state.
• Approved only as an anesthetic. FDA approved ketamine hydrochloride (Ketalar) as an intravenous or intramuscular injection for induction and maintenance of general anesthesia. In its October 10, 2023 communication on compounded ketamine, FDA said plainly that "ketamine is not FDA approved for the treatment of any psychiatric disorder." Psychiatric use is off-label.
• Esketamine is a different product with a REMS. Spravato, the esketamine nasal spray, is approved for treatment-resistant depression and for depressive symptoms in adults with major depressive disorder with acute suicidal ideation or behavior. FDA describes its REMS as requiring the drug to be "dispensed and administered in medically supervised health care settings" certified in the REMS that monitor patients for at least two hours after each dose. It cannot be sent home.
• Compounded ketamine is not approved for anything. FDA's words: compounded drugs "do not have any FDA-approved indications or routes of administration."

What did FDA's warnings say about at-home ketamine?

FDA issued a compounding risk alert on February 16, 2022 about at-home use of compounded ketamine nasal spray, and a broader warning on October 10, 2023 covering oral and sublingual forms. The 2023 warning names telemedicine directly: FDA said it understands "the ability to obtain such products through telemedicine platforms and compounders for at-home use may be attractive to some patients," but that "the lack of monitoring for adverse events, such as sedation and dissociation, by an onsite health care provider may put patients at risk." It cited an April 2023 adverse event report of respiratory depression in a patient who took compounded oral ketamine at home for PTSD.

A warning is not a prohibition. Off-label prescribing remains lawful. But FDA's statements are the first thing a regulator, a plaintiff's lawyer or a malpractice carrier will quote, and a program that markets compounded ketamine as a depression treatment invites the advertising problems covered in our advertising claims checklist.

Can ketamine be prescribed by telehealth without an in-person exam?

Through December 31, 2026, federal law allows it. The DEA and HHS fourth temporary extension (90 FR 61301, 21 CFR 1307.41) lets DEA-registered practitioners prescribe Schedule II through V drugs after a real-time audio-video telemedicine encounter, without a prior in-person evaluation, if every other part of 21 CFR part 1306 is met.

From January 1, 2027, it depends on DEA. If the special registration rule (proposed at 90 FR 6541, January 17, 2025) is final and effective, ketamine as a Schedule III drug would fall under the basic Telemedicine Prescribing Registration as proposed, with state telemedicine registrations and PDMP checks. If DEA extends the temporary rule, nothing changes. If neither, the Ryan Haight Act's in-person evaluation requirement at 21 U.S.C. 829(e) returns, and every at-home ketamine patient who has not been seen in person by the prescriber needs a visit before the next prescription. See what changes on January 1, 2027.

The buprenorphine rule at 21 CFR 1306.51 does not help. It covers only Schedule III to V drugs approved for opioid use disorder.

What do in-clinic ketamine programs need?

An infusion clinic or Spravato office stores and administers a controlled substance, so it needs a DEA registration at that location. DEA's rule at 21 CFR 1301.12(a) requires a separate registration for each principal place of business where controlled substances are dispensed. A telehealth psychiatrist who evaluates patients remotely and refers them to that clinic for administration is a common model; who holds which registration, and who is the prescriber of record, should be written down before the first patient. Spravato sites also need REMS certification for the setting and must follow its monitoring requirement.

What state rules apply?

We have not found a state statute that addresses ketamine by name in telehealth law. The general controlled substance limits apply:

• Connecticut bars Schedule I through III by telehealth, except Schedule II or III drugs for medication-assisted treatment or to treat psychiatric disabilities or substance use disorders (Conn. Gen. Stat. § 19a-906(c), as amended by Public Act 25-168). Ketamine prescribed for depression would need to fit that exception; take it to Connecticut counsel.
• Alabama requires a prior in-person encounter within 12 months for any controlled substance prescribed by telehealth (Ala. Code § 34-24-704).
• Colorado out-of-state telehealth registrants may not prescribe controlled substances at all (C.R.S. § 12-30-124).
• Louisiana Board of Medical Examiners rules require an in-person visit within the past year before a controlled substance is prescribed by telemedicine (La. Admin. Code tit. 46, pt. XLV, § 7513).

Many states also require a PDMP check before a controlled substance prescription and a state controlled substance registration in some jurisdictions. The state pages in our telehealth law index list what we verified for each.

What should a ketamine program document?

• The off-label rationale and informed consent discussion, in writing, naming the FDA warnings.
• Screening and exclusion criteria, and who applies them.
• For at-home dosing: who is present, how the patient is monitored, and the emergency plan. See emergency protocols for a telehealth practice.
• The compounding pharmacy's licensure in each patient state and its controlled substance registrations. Our pharmacy partner selection post has the checklist.
• For every patient, whether the prescriber has seen them in person, for the January 2027 decision.

Our DEA Telemedicine Readiness engagement ($1,450) builds that roster and the 2027 decision tree, and Platform, Pharmacy & Lab Selection ($2,450) vets compounding partners. All of it is research for your counsel, not legal advice. Federal rule history is on the DEA telemedicine rules hub.