Any psilocybin or MDMA approval this cycle ships with a mandatory REMS requiring certified sites and trained monitors.

If the FDA (the US drug regulator) approves psilocybin or MDMA for medical use, it will attach a strict safety program called a REMS (Risk Evaluation and Mitigation Strategy). This means you could only get the treatment at specially certified locations with trained staff watching over you — not at a regular doctor's office or at home. This limits how many people can actually access the treatment, at least at first.

Patient-protection mandate is non-negotiable given dissociative risk profile; my division will not waive site controls regardless of advocacy pressure.