FDA status, and what it means for you
Ketamine is not FDA-approved to treat depression, PTSD, anxiety, OCD, or chronic pain, and the ketamine used at Ascend is a compounded preparation, which is not FDA-approved for any use. The FDA has not reviewed the medication we give you for safety, effectiveness, or manufacturing quality, and you deserve to know that before you start. You will hear it again during your evaluation, in plain language, with time to ask questions before you decide anything.
Compounded medications, meaning preparations put together by a pharmacy rather than manufactured and reviewed as a finished product, are not FDA-approved and are not evaluated by the FDA for safety, effectiveness, or manufacturing quality. That is exactly why we never mail ketamine to your home and never hand you a supply to self-administer: every dose is prepared for in-clinic use and given at our Wesley Chapel suite, with a trained team member monitoring you from check-in to discharge.
The ketamine used here is a compounded preparation and is not FDA-approved. Ascend administers it as a subcutaneous injection; we do not offer nasal-spray or at-home ketamine programs.
The FDA has publicly warned about ketamine used for psychiatric conditions without proper monitoring, and specifically about compounded ketamine sent to people to take at home. Ascend does not do that. Every dose is given in our clinic, your vital signs are checked before, during, and after, and you stay until the medication has worn off.
Most published research on ketamine for depression studied intravenous infusions or the FDA-approved nasal spray. Ascend uses a subcutaneous injection, which has a smaller body of evidence behind it. We would rather say that plainly than imply the studies were run on exactly what we give you.
Before a first dose you complete a full psychiatric evaluation with a licensed prescriber and sign an informed consent covering the compounded, non-FDA-approved status of the medication, its risks, and the alternatives. Here is what we watch for and how we protect you. Dissociation during the session is expected and temporary, which is why you are monitored continuously and never left alone. Short-term rises in blood pressure and heart rate are checked before and during every session. Nausea is managed on site. And because frequent or long-term use carries a risk of bladder and urinary problems, we limit how often you dose and reassess at every follow-up rather than continuing indefinitely. Ketamine is a Schedule III controlled substance with a potential for misuse and dependence. You cannot drive yourself home afterward.
