One Substance, Seven Legal Realities:Classification Cascades in the Psychedelic Medicine Transition
H. Tamba
SSRN Electronic Journal 2026 preprint DOI: 10.2139/ssrn.6575604 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Review |
|---|---|
| Keywords | Corporate governance Drug approval Authorization Schedule Statute Controlled substance Law Public relations Public administration |
| Key findings | Psilocybin's legal status is fragmented across seven governance systems, with contradictory classifications ranging from Schedule I to authorized therapeutic use. The authors argue that potential FDA approval of COMP360 would place psilocybin in the rare category of simultaneously approved medicine and Schedule I substance, exacerbating regulatory inconsistency. |
Abstract
Importance Psilocybin simultaneously holds contradictory legal classifications across seven overlapping governance systems—Schedule I under U.S. federal law, FDA Breakthrough Therapy designation, authorized therapeutic use in Oregon and Colorado, operational state-level medical access in New Mexico, national medical rescheduling in Australia, and an active petition for DEA rescheduling. As COMPASS Pathways advances toward FDA approval of COMP360 following two consecutive positive Phase 3 trials, the substance may join the vanishingly rare category of simultaneously approved medicines and Schedule I controlled substances, deepening rather than resolving this regulatory fragmentation.