A ketamine program is one of two businesses. An infusion clinic keeps the drug on site, so it needs a DEA registration at that address and the records that go with it. An at-home program mails a compounded product after a video visit, and as of September 2026 it rests on a federal regulation that expires December 31, 2026.
What ketamine is, legally
Ketamine has been a federal Schedule III controlled substance since August 12, 1999, and its label covers anesthesia only. FDA has said so directly: “Ketamine is not FDA approved for the treatment of any psychiatric disorder.” Every psychiatric use of racemic ketamine is off-label. That is lawful, but it means no label tells you the dose, the setting or the monitoring, so your protocols carry the whole weight.
The approved psychiatric product is Spravato (esketamine), and its safety program shows what FDA considers adequate here. A certified setting must “Have a prescriber onsite during SPRAVATO administration and monitoring.” Patients are watched at least two hours, and “SPRAVATO is not dispensed for use outside the certified healthcare setting.”
The infusion clinic: the drug is on site, so the address is registered
“A separate registration is required for each principal place of business or professional practice at one general physical location where controlled substances are manufactured, distributed, imported, exported, or dispensed by a person” (21 C.F.R. § 1301.12(a)). Administering counts as dispensing.
Operators lean on the prescribing-only exception. It covers an office “where controlled substances are prescribed but neither administered nor otherwise dispensed as a regular part of the professional practice of the practitioner at such office, and where no supplies of controlled substances are maintained.” An infusion suite fails both halves. Your medical director’s registration at a different address does not cover it.
What the registered location then owes DEA:
| Duty | Rule | What it says |
|---|---|---|
| Storage | § 1301.75(b) | “a securely locked, substantially constructed cabinet” |
| Inventory | § 1304.11(a), (c) | A separate inventory for each registered location, repeated “at least every two years” |
| Administration log | § 1304.03(d), § 1304.22(c) | Required where a practitioner regularly administers and charges for it. Patient name and address, date, amount, and the initials of the person who administered |
| Retention | § 1304.04(a) | “at least 2 years,” available for inspection |
| Theft or loss | § 1301.76(b) | Written notice “within one business day of discovery,” then DEA Form 106 within 45 days |
| Buying stock | § 1306.04(b) | A prescription “may not be issued in order for an individual practitioner to obtain controlled substances” for general dispensing. Stock is ordered under the registration |
The registrant has to be someone the state lets dispense. DEA registers a practitioner “if the applicant is authorized to dispense” under “the laws of the State in which he practices” (21 U.S.C. § 823(g)(1)). A management company with no state dispensing authority does not meet that test. No DEA document says so in those words; it follows from the statute, and it is why registration sits with the physician or the professional entity in an MSO-backed clinic.
Some states add their own registration. Illinois requires one “for each place of business or professional practice where controlled substances are located or stored,” Massachusetts requires registration with its health commissioner, and Texas eliminated its version on September 1, 2016. We checked only those three.
Two federal cases show how this gets enforced. A Missouri indictment alleged infusions at a suite that was not a registered location, by a physician with no registration of his own; one physician pleaded guilty and was sentenced in September 2025. A Montana clinic physician settled civil claims in 2023 after an inspection alleged recordkeeping failures and ketamine stored at unregistered locations. Both turned on address and paperwork.
The at-home model rests on a regulation with an end date
Prescribing a Schedule III drug to a patient you have never examined in person is allowed today only under 21 C.F.R. § 1307.41. That section requires a live interactive visit and “expires at the end of December 31, 2026.” The Ryan Haight Act sits underneath it, unchanged. What happens on January 1, 2027 covers the three outcomes.
FDA’s position is on the record. Its October 10, 2023 alert says: “Home use of compounded ketamine products presents additional risk because onsite monitoring by a health care provider is not available,” and describes a report of respiratory depression after compounded oral ketamine taken at home. The February 16, 2022 alert says: “There is no FDA-approved ketamine nasal spray product.”
Compounded ketamine is lawful only inside section 503A: made for “an identified individual patient based on the receipt of a valid prescription order.” 503A vs. 503B sourcing explains the difference. The Massachusetts pharmacy board said it would “take no action to prevent the continued compounding and dispensing of ketamine products,” and in the same advisory endorsed the FDA alerts.
States have started writing ketamine rules
Alabama. The medical board’s position statement, revised January 15, 2026, covers off-label ketamine for treatment-resistant depression. “Only a licensed physician may prescribe ketamine.” Others may assist “as long as the prescribing physician remains onsite.” On home use: “A physician should never allow the patient to administer ketamine for psychiatric reasons at home and should never allow a family member to monitor the patient.” It is a position statement, and a board measures conduct against its own statements.
Texas, proposed only. The Texas Medical Board published proposed rules for parenteral ketamine therapy in the Texas Register on July 10, 2026. As of September 17, 2026, the Board still lists them as proposed. As drafted, every practice “must be registered by the Medical Director with the Board,” the director “may provide oversight at no more than three (3) medical practices, clinics, or facilities of any type,” and when an RN administers, “a physician or practitioner must be physically present on site at all times.” The draft bars parenteral ketamine “prescribed for home use.” That wording does not reach oral or sublingual products. If you are hiring a Texas medical director for a ketamine clinic, ask how many sites that physician already covers.
Nursing boards. Kentucky’s says a trained RN may give sub-anesthetic ketamine and an LPN may not. Nevada’s requires the licensed practitioner to be “readily available in the facility” for the whole infusion and states: “Standing orders or protocols are not used.” Arizona’s allows RN administration by several routes with individualized orders. These are advisory opinions, and they describe the standard an IV or wellness clinic adding ketamine will be held to.
Many states have published nothing specific. We could not confirm ketamine rules in Mississippi, Tennessee, Colorado, Florida or California.
What we will and will not support
We do support at-home ketamine programs. We support them on three conditions, and we decline the work when they are not met.
- Oral or sublingual only. Nothing parenteral goes home. Injectable and IV ketamine stay in a clinic with a DEA registration at that address, for the reasons above. The Texas Medical Board has proposed the same line, and the FDA alerts that worry us most describe at-home use without onsite monitoring.
- A documented diagnosis and a prescription monitoring check. A treatment-resistant diagnosis in the chart, not a symptom score alone, plus a monitoring program check at intake and on a set schedule after it. Real programs decline patients, and ours do.
- A responsible adult in the home who is not the monitor. Someone is present for safety. Nobody treats a family member as the clinical monitor, and no protocol we approve asks one to.
Where this leaves us against Alabama is worth stating plainly, because the honest answer is not flattering to the model. That board says a physician “should never allow the patient to administer ketamine for psychiatric reasons at home and should never allow a family member to monitor the patient.” Our three conditions answer the second half of that sentence and not the first. So in a state whose board has said never, our answer is also no. Conditions do not override a board.
What this means for you
Decide which business you are in. If the drug is on your premises, get the registration at that address in the right name before the first vial arrives, and start the inventory and the administration log on day one. If you prescribe for home use, count the patients nobody has examined in person and build an in-person path before December 31, 2026. In either model, read your state board’s statement if it has one, and write patient-specific orders.
Related reading
Frequently asked questions
Is at-home ketamine by telehealth legal?
As of September 2026, federal law allows a Schedule III prescription without an in-person evaluation only under a temporary rule, 21 C.F.R. § 1307.41, which expires December 31, 2026. FDA has warned twice about at-home compounded ketamine. Alabama’s medical board says a physician should never allow psychiatric ketamine to be self-administered at home. State rules vary.
Does a ketamine clinic need its own DEA registration?
Yes, if ketamine is stored or administered there. Federal rules require a separate registration for each location where controlled substances are dispensed, and administering is a form of dispensing. The exception for prescribing-only offices ends once drug supplies are kept on site or administration is a regular part of the practice.
Can an MSO hold the DEA registration for a ketamine clinic?
DEA registers practitioners who are authorized to dispense under the law of the state where they practice. A management company with no state authority to dispense does not meet that condition. We found no DEA document that says this in those words. In practice the registrant is the physician or the professional entity.
Can a registered nurse administer ketamine infusions?
It depends on the state. Nursing boards in Kentucky, Nevada and Arizona say a trained RN may give sub-anesthetic doses under patient-specific orders, with a licensed practitioner available. Alabama’s medical board requires the prescribing physician on site. Texas has proposed, and as of September 17, 2026 not adopted, an on-site practitioner requirement.
Is ketamine FDA approved for depression?
No. Racemic ketamine is approved as an anesthetic, and FDA has stated it is not approved for any psychiatric disorder. Esketamine nasal spray, sold as Spravato, is approved for treatment-resistant depression and is available only in certified healthcare settings under a safety program that requires on-site monitoring for at least two hours.
This is general information, not legal advice. Rules vary by state and change. Confirm your own facts with counsel.