FDA Docket Comment: A Schedule IV Framework for Psychedelic Therapeutics
My public comment proposes product-specific evaluation, supervised clinical access, provider training, and outcomes tracking for future FDA-approved psychedelic therapies.
Download the original PDFThis comment addresses FDA Docket No. FDA-2026-N-7542, “Considerations for Potential Future Therapeutic Use of Psychedelic Drugs.” It reflects my individual professional perspective as a psychiatric and critical care nurse and PMHNP student.
I propose that any future scheduling decision follow FDA approval and a product-specific assessment of evidence and abuse liability. The comment discusses Schedule IV as a potential outcome for approved products when supported by that assessment, rather than a single designation for an entire class of substances.
The full comment also addresses trauma-informed care, inpatient psychiatric settings, clinician training, patient safety, equitable access, and standardized long-term outcomes data. Download the original eight-page PDF above to read the complete submission text and source list.