FDA status, and what it means for you
Read this before the rest of the page, because it changes how much weight everything else deserves. Ketamine is not FDA-approved to treat depression, PTSD, anxiety, OCD, or chronic pain. The preparation Ascend uses is compounded, which is not FDA-approved for any use, and the FDA has not reviewed it for safety, effectiveness, or manufacturing quality. That is not fine print. It is the first fact you should be weighing.
Compounded means a pharmacy assembles the preparation instead of a manufacturer producing a finished product and submitting it for review. Compounded preparations are not FDA-approved and are not evaluated by the FDA for safety, effectiveness, or manufacturing quality. A licensed prescriber may still prescribe one within the standard of care. What you do not get is the regulatory review that sits behind a medication you pick up at a retail counter, and no clinic can hand that back to you by describing the treatment more confidently.
The FDA has publicly warned about ketamine used for psychiatric conditions without proper monitoring, and specifically about compounded ketamine shipped to people to take at home. So the question worth asking any program you are considering, this one included, is where the medication is given and who is watching you while it works. Our answer: we never mail ketamine to a patient and never hand anyone a supply to self-administer. Every dose is prepared for in-clinic use and given at our Wesley Chapel suite as a subcutaneous injection, with a trained team member present from check-in to discharge, and we do not run nasal-spray or at-home ketamine programs. The preparation given there is compounded and is not FDA-approved. Vital signs are checked before, during, and after, and you stay until the medication has worn off.
One more thing worth knowing while you decide. Most published research on ketamine for depression studied other routes of administration. Ascend uses a subcutaneous injection, which has a smaller body of evidence behind it. We would rather say that plainly than let you assume the studies were run on exactly what we give you.
Choosing this is a two-step process, not a purchase. Before any 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. The risks in that consent are specific, and they are easier to think about now than at the front desk: dissociation during the session, expected and temporary, which is why you are monitored continuously and never left alone; short-term rises in blood pressure and heart rate, checked before and during every session; nausea, managed on site; and, because frequent or long-term use carries a risk of bladder and urinary problems, a deliberate cap on how often you dose, reassessed at every follow-up rather than continued indefinitely. Ketamine is a Schedule III controlled substance with a potential for misuse and dependence. You cannot drive yourself home afterward.
