Executive Order 14401, signed April 18, 2026, told federal agencies to speed up psychedelic drug reviews and to start rescheduling reviews once a drug finishes Phase 3, so rescheduling can follow FDA approval. Six months later, psilocybin is still a Schedule I drug, no rescheduling rule has been published, and California law is unchanged. For people in San Diego, possession is still a crime.1,2
What the order directs
The order, titled "Accelerating Medical Treatments for Serious Mental Illness," was published in the Federal Register on April 22, 2026.1 It does five main things:
- Priority vouchers. The FDA is to issue Commissioner's National Priority Vouchers to suitable psychedelic drugs that already have breakthrough designation.
- Right to Try. The FDA and DEA are to create a Right to Try pathway, including for ibogaine, with a way to handle Schedule I rules.
- State partnerships. HHS, through ARPA-H, is to put at least $50 million of existing money into partnerships with states that run psychedelic programs.
- Data sharing. HHS, the FDA and the VA are to share data and expand trial participation.
- Rescheduling. The Attorney General is to start and finish a rescheduling review "as quickly as practicable" for a Schedule I drug that completes Phase 3 trials for a serious mental illness, so rescheduling can follow FDA approval.
The order sets no calendar deadlines, and it doesn't reschedule anything by itself.1
What has happened since
Six days later, on April 24, the FDA awarded priority vouchers to two psilocybin drugs, Compass Pathways' COMP360 for treatment-resistant depression and the Usona Institute's psilocybin for major depression, plus a methylone drug for PTSD. A voucher can cut FDA review to about one to two months after filing. The FDA also let Compass submit its application on a rolling basis.3,4
Compass said in August that some sections of its application were in and that it expects to finish submitting in the fourth quarter of 2026, with a launch in the first half of 2027 if the FDA approves the drug and the DEA reschedules it. No FDA decision date has been disclosed.5 San Diego has a stake: UC San Diego and Kadima Neuropsychiatry Institute in La Jolla were sites for Compass's Phase 3 trials. Our San Diego research guide covers those studies.
The FDA has also finalized its guidance for psychedelic clinical trials (July 14), held a public hearing on future therapeutic use (September 14), and asked for input on ibogaine trial design, with comments due November 20.6,7,8
What hasn't changed
- Psilocybin is still Schedule I. It's listed in the DEA's Schedule I regulations in the version in effect October 9, 2026.2
- No rescheduling or Right to Try rule. No DEA proposal to reschedule psilocybin and no Right to Try implementing rule had appeared in the Federal Register as of October 19, 2026.9,10 A separate petition to move psilocybin to Schedule II has been under HHS review since the DEA referred it in August 2025.11
- California law is the same. Possession is still a crime under the Health and Safety Code, and there's no state program. See our guide to the law in San Diego.
The rescheduling the order contemplates would cover an FDA-approved medicine, likely given under medical supervision, not mushrooms. Even if psilocybin itself moved to Schedule II, possessing mushrooms without a prescription would remain illegal. California's AB 1021, signed in 2023, already lets state health professionals prescribe and dispense such a drug once it's federally rescheduled. Its author said it "does not decriminalize or legalize any controlled substance for any nonmedical use."12
What to watch
Three dates matter for San Diego: when Compass finishes its FDA application, when the FDA rules, and when the DEA acts on rescheduling. Until all three happen, nothing about the executive order changes what's legal here. We track each step on our news page, and our story on this fall's ballot covers the state side.
This is general information, not legal advice.
Sources
- Executive Order 14401: Accelerating Medical Treatments for Serious Mental Illness. Federal Register, April 22, 2026.
- 21 CFR 1308.11, Schedule I. Electronic Code of Federal Regulations, version effective October 9, 2026.
- Compass, Usona score FDA national priority vouchers. Fierce Biotech, April 24, 2026.
- Federal agencies' next moves to accelerate the availability of psychedelic therapies. Reason Foundation, April 29, 2026.
- Compass Pathways second quarter 2026 results. Compass Pathways via SEC, August 5, 2026.
- Psychedelic Drugs: Considerations for Clinical Investigations; Guidance for Industry. Federal Register, July 14, 2026.
- Considerations for potential future therapeutic use of psychedelic drugs: public hearing. U.S. Food and Drug Administration, September 14, 2026.
- Ibogaine clinical trial design: request for information. Federal Register, October 6, 2026.
- Federal Register document search: psilocybin. Federal Register, accessed October 20, 2026.
- Federal Register document search: "Right to Try". Federal Register, accessed October 20, 2026.
- DEA asks health officials to review psilocybin rescheduling. Law360, August 18, 2025.
- AB 1021 analysis. Senate Public Safety Committee, 2023.
