DEA remains decoupled from any FDA action and does not reschedule within 12 months.

Even if the FDA (the US drug regulator) approves a psychedelic medicine, a completely separate agency — the DEA (the Drug Enforcement Administration) — controls whether it stays classified as a dangerous, restricted substance. These two agencies move independently, and the DEA is expected to hold its position for at least another 12 months. This matters because DEA classification determines who can legally prescribe, possess, and use a drug.

FDA approval doesn't bind scheduling. Enforcement responsibilities and diversion concerns keep us conservative regardless of clinical momentum.