You found a clinic. The website says "FDA-approved" in large letters, or maybe "FDA-cleared," or maybe it just says "ketamine therapy" and leaves you to wonder. Before you book, you want to know what that claim actually covers. This guide shows you how to check, from anywhere in the country, in about an afternoon.
It is written for anyone for whom FDA status is part of the decision. That covers most people. Among the 443 Midwest adults in a ten-state poll we funded over the summer, 59 percent expected FDA approval to weigh big or decisively on trying an unfamiliar depression treatment. Those figures are the final, validated ones.
First, know what you are looking for
There are four labels you are likely to encounter:
- FDA-approved: A drug that has been reviewed and approved for a specific condition. Spravato, the brand of esketamine, has approval for depression that other treatment has not relieved.
- FDA-cleared: A device reviewed through the FDA's device pathway. TMS systems hold clearance for adult major depression after antidepressants fall short.
- Off-label: An approved drug used for a condition it is not approved for. IV ketamine for depression is off-label, because generic ketamine is approved as an anesthetic.
- Compounded: A pharmacy's custom preparation for one named patient. Compounded drugs are not FDA-approved. Some at-home ketamine products fall in this category.
A clinic can be completely legitimate in any of these categories. The point is to know which one you are dealing with.
Step 1: Ask the clinic in writing
Email or message the clinic with three questions:
- What exact product or device will be used in my treatment?
- Is it FDA-approved or FDA-cleared, and for what condition?
- Is my intended use on-label or off-label?
A written answer is useful because it is specific. Watch for wording such as "FDA-registered facility" or "FDA-approved ingredients," since neither says your actual treatment was approved for depression.
Step 2: Check the drug yourself
The FDA maintains a public database of approved drugs, called Drugs@FDA, where you can search by brand or generic name and read the official label. The label's "Indications and Usage" section lists exactly what the drug is approved to treat. If depression is not listed for the product being offered, the use is off-label.
For esketamine, the label also describes its safety program, which limits dosing to certified clinics that observe patients afterward. The drugmaker's website has a treatment center locator, and finding a clinic on it is a quick way to confirm it belongs to the program. Brain Recovery Centers also walks through how the Spravato program works for patients.
Step 3: Check a device
For TMS, ask the clinic for the device manufacturer and model. The FDA's medical device databases let you search for clearance records by device name or manufacturer. The record will show what the device was cleared to treat. If a clinic is offering TMS for a condition outside its cleared uses, that is off-label device use, and you should ask why.
Step 4: Check the prescriber
Each state medical board runs a public license search. Enter the name of whichever physician or nurse practitioner is supervising you. You can confirm that the license is active and see whether there are disciplinary actions. For telehealth prescribers, make sure they hold a license in your home state, because legally the care happens where you are.
Step 5: Check your coverage at the same time
FDA status and insurance tend to travel together. Plans are generally more willing to cover approved and cleared treatments for their labeled uses, often after prior authorization, and less likely to cover off-label or compounded ones.
That matters because coverage outranked everything else in our survey. Forced to name two provider priorities, 85 percent of respondents listed insurance, while FDA approval got 27 percent, just above fast results at 24 percent. In a different question, 65 percent said coverage would weigh big or decisively on trying any treatment.
So while you are verifying status, phone your plan using the card in your wallet and ask three things: is this exact treatment covered for depression, what does prior authorization need, and which nearby providers are in network.
Step 6: Weigh the practical side
Proximity came second in our survey, with 43 percent picking a provider close to home. Supervised treatments like esketamine and TMS involve repeated visits. Esketamine also means you need a ride home, because you cannot drive until the next day. Before committing, check the distance and the schedule, not just the label.
Warning signs worth noticing
- A clinic that says "FDA-approved" without naming the product or condition.
- Promises of certain results or a cure.
- Pressure to pay for a package of sessions up front before an evaluation.
- An at-home product described as if it were the same as supervised esketamine.
- No clear answer about who the supervising clinician is.
Why doing this yourself helps
Most people do not know which depression treatments are approved. Spravato is the lone ketamine-family product with approval for treatment-resistant depression, yet in our poll it was unheard of for 73 percent, and another 21 percent knew nothing beyond the name. That makes it easy for different products to blur together in advertising and news coverage.
Bring your findings to your doctor
Checking status yourself does not replace a clinician's judgment. It helps you have a better conversation. Most respondents plan to rely on their doctor regardless; 74 percent said that doctor's recommendation would do the most to get them to try something new. Bring what you found, and ask whether the treatment makes sense for your history.
Thoughts of suicide outrank any database search. Put the research aside and text or call 988; the Suicide and Crisis Lifeline never closes.
Methodology
Our questionnaire, Pollfish ID 395586438, stayed open to Pollfish panelists through June 23, 2026, gathering 443 answers from residents aged 18 to 64 of Kansas, Indiana, Wisconsin, Missouri, Minnesota, Iowa, Illinois, Oklahoma, Ohio or Nebraska. A consent screener came first for everyone. Where several answers were allowed, a percentage means the portion of all respondents who picked it. The results are final after validation. The publisher commissioned the survey and bore its cost. Nothing on this page is medical or legal advice.