Quick answer: There is no psilocybin FDA approval yet. As of September 26, 2026, the closest candidate is Compass Pathways’ COMP360, a psilocybin drug for treatment-resistant depression. The FDA agreed in April 2026 to review its application on a rolling basis and awarded it a Commissioner’s National Priority Voucher, and Compass says it will finish submitting the application in the fourth quarter of 2026.
If the FDA approves it, that approval would cover one drug product. By itself it would not legalize psilocybin mushrooms, change the federal status of spores, or override the four states that restrict spores. We will update this post when the FDA decides.
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Intended use and disclaimer. We sell Psilocybe cubensis spore syringes for microscopy, taxonomy and educational use only. This page is general information about the law and the drug-approval process, not legal or medical advice. Regulatory timelines change, so check the current status before relying on anything here.
In this guide
- Where psilocybin FDA approval stands in September 2026
- Compass Pathways and COMP360: the timeline
- Usona Institute’s psilocybin program
- The April 2026 executive order
- What an approval would change: one product gets rescheduled
- What it would not change for spore buyers
- State laws that are waiting on the FDA
- Frequently asked questions
- Sources
Where psilocybin FDA approval stands in September 2026
No drug containing psilocybin has been approved by the FDA. Psilocybin and psilocin remain in Schedule I of the Controlled Substances Act, the category for substances with no currently accepted medical use.
One company is close to asking for a decision. Compass Pathways has reported results from two Phase 3 trials of COMP360, its psilocybin formulation, in treatment-resistant depression, and it is sending its New Drug Application (NDA) to the FDA in pieces under a rolling review. In late September 2026, chief executive Kabir Nath told two investor conferences that the company remained on track to complete the submission in the fourth quarter. Until the submission is complete and the FDA accepts it, there is no decision date.
Compass Pathways and COMP360: the timeline
| Date | What happened |
|---|---|
| October 2018 | The FDA gave COMP360 psilocybin therapy Breakthrough Therapy designation for treatment-resistant depression. |
| April 18, 2026 | The President signed an executive order on psychedelic drug development (see below). |
| April 24, 2026 | Compass announced that the FDA had granted its request for a rolling NDA review and selected COMP360 for a Commissioner’s National Priority Voucher. |
| July 7, 2026 | Compass reported 26-week results from its second Phase 3 trial, COMP006, and said the final NDA submission was on track for the fourth quarter of 2026, with a launch expected in the first half of 2027 if the FDA approves and the DEA reschedules. |
| September 22 and 24, 2026 | Chief executive Kabir Nath repeated the fourth-quarter target for completing the submission at two investor conferences. |
The priority voucher is the reason people expect a fast answer. The FDA’s voucher program offers a shortened review of one to two months after a complete application is filed, and it does not lower the standard the drug has to meet. Compass expects a launch in the first half of 2027 if everything goes as it hopes. That is a company projection, not a scheduled date.
Usona Institute’s psilocybin program
The other long-running psilocybin drug program belongs to the Usona Institute, a nonprofit medical research organization. The FDA gave Usona’s psilocybin program Breakthrough Therapy designation for major depressive disorder in November 2019, and in March 2024 Usona launched uAspire, a Phase 3 trial of psilocybin for major depressive disorder. In April 2026 the FDA gave Usona’s program a Commissioner’s National Priority Voucher as well, at the same time as COMP360’s. As of late September 2026, Usona has not announced Phase 3 results or an NDA submission.
The April 2026 executive order
On April 18, 2026, President Trump signed an executive order titled “Accelerating Medical Treatments for Serious Mental Illness.” It was published in the Federal Register on April 22 as Executive Order 14401. It directs the FDA to give priority vouchers to psychedelic drugs that hold Breakthrough Therapy designation, directs the FDA and DEA to set up a pathway for patient access under the federal Right to Try Act, and tells the Attorney General, consulting with HHS, to review any product containing a Schedule I substance that has completed Phase 3 trials for a serious mental health disorder, so that products the FDA approves can be rescheduled quickly.
The order does not legalize psilocybin, does not reschedule it, and does not guarantee any approval. It says nothing about spores or mushrooms. Our 50-state guide notes the same.
What an approval would change: one product gets rescheduled
An FDA approval would apply to one specific drug: COMP360 as manufactured and labeled, given under the conditions the FDA sets. Because psilocybin is in Schedule I, the approved product would then need to be moved to a lower schedule before it could be prescribed. Federal law sets a deadline for that step: once HHS recommends scheduling for a newly approved drug, the Attorney General must issue an interim final rule within 90 days (21 U.S.C. § 811(j)).
There is a close precedent. In June 2018 the FDA approved Epidiolex, a prescription drug made from cannabidiol. In September 2018 the DEA placed FDA-approved cannabidiol drugs like it in Schedule V, the lowest schedule, and said in its announcement that marijuana and marijuana-derived CBD otherwise remained illegal. The approved product moved, and the plant stayed where it was. If psilocybin follows the same pattern, the approved drug would be rescheduled and psilocybin in general would stay in Schedule I. The executive order points the same way, since it asks for a rescheduling review of approved products, not for removing psilocybin from Schedule I.
What it would not change for spore buyers
- The status of spores. Spores are legal under federal law today because they contain no psilocybin or psilocin, as the DEA’s January 2024 letter explains. An approval of a drug product would not add to or subtract from that. Our post on whether mushroom spores contain psilocybin covers the letter in detail.
- Mushrooms and germination. Mushrooms and germinated material would still contain a Schedule I substance. Growing them would still be manufacturing under federal law.
- The four state spore laws. Georgia and Idaho ban spores, and California and Florida restrict selling and shipping them. Those statutes name spores directly, and an FDA decision does not amend state law. We do not ship to any of the four.
- How spores are sold. We would still sell spore syringes for microscopy and taxonomy only, and we would still decline to give cultivation advice. Our post on why spores are sold for microscopy only explains why.
In short, an approval would make a single psilocybin medicine available by prescription. It would not touch what you can buy from a spore syringe vendor or what you can legally do with it.
State laws that are waiting on the FDA
Some states have passed laws that take effect only after federal action, and Virginia is a clear example. In April 2026, Governor Abigail Spanberger signed HB 1347 and SB 379, which direct the state Board of Pharmacy to reschedule an FDA-approved psilocybin formulation, consistent with the federal change, at its next quarterly meeting after the federal scheduling order has been published for 30 days. The law changes nothing until then, and psilocybin remains Schedule I in Virginia. See our Virginia guide.
Separate from the FDA process, Oregon, Colorado and New Mexico have created their own psilocybin programs under state law. Those programs do not depend on an FDA approval, and none of them changes the law on spores. Our roundup of psilocybin laws in 2026 covers what changed this year state by state.
Frequently asked questions
Has the FDA approved psilocybin?
No. As of September 26, 2026, no psilocybin drug has been approved. Compass Pathways expects to finish submitting its application for COMP360 in the fourth quarter of 2026.
When could the FDA decide on COMP360?
Compass has said it expects a launch in the first half of 2027. That depends on the FDA accepting the complete application, the voucher review, and DEA rescheduling, and it is a company projection rather than a set date.
What is a Commissioner’s National Priority Voucher?
It is an FDA program that offers closer communication with the agency and a review of about one to two months after a complete application is filed. It does not change the evidence the FDA requires for approval.
Would FDA approval make magic mushrooms legal?
No. An approval covers one drug product. If the Epidiolex precedent holds, the approved product would be rescheduled while psilocybin mushrooms stay in Schedule I.
Would FDA approval change the law on mushroom spores?
No. Spores are already legal under federal law and in 46 states because they contain no psilocybin, and the four states that restrict spores name them in their own statutes.
Did the April 2026 executive order legalize psilocybin?
No. It directs agencies to speed up review and prepare for rescheduling after an FDA approval, and it calls for a Right to Try pathway. It does not change the legal status of psilocybin or spores.
Will you update this page?
Yes. We will update it when Compass completes its submission and again when the FDA decides.
Sources
- Compass Pathways, rolling review and priority voucher announcement (April 24, 2026)
- AllSci, “FDA Grants Rolling Review for Compass COMP360” (April 27, 2026)
- Compass Pathways, COMP006 26-week data and NDA timing (July 7, 2026)
- MarketBeat, “Compass Pathways Targets Q4 COMP360 NDA Completion, Eyes 2027 Launch” (September 24, 2026) and Yahoo Finance on Compass at the Morgan Stanley healthcare conference (September 22, 2026)
- Compass Pathways, Breakthrough Therapy designation (October 2018) and Psychiatric Times on COMP360’s regulatory path
- Business Wire, Usona Breakthrough Therapy designation (November 22, 2019) and ClickOnDetroit coverage (November 27, 2019)
- Usona Institute, uAspire Phase 3 launch statement (March 20, 2024), Usona press releases and Clinical Trials Arena on the uAspire trial
- Fierce Biotech on the April 2026 priority vouchers for Compass and Usona and Psychedelic Alpha on the same awards
- Executive Order 14401 in the Federal Register (April 22, 2026), Morgan Lewis on the April 18, 2026 executive order and Harris Sliwoski on the same order
- 21 U.S.C. § 812, Schedule I criteria and listings and § 811(j), interim scheduling of newly approved drugs
- DEA, “FDA-approved drug Epidiolex placed in schedule V” (September 27, 2018) and the Federal Register order
- Virginia 2026 Acts of Assembly, Chapter 306, Marijuana Moment on the signing and Rouleau Law’s explainer
- DEA letter on the federal status of spores (January 2, 2024, PDF)
Psilocybe cubensis spore syringes
Our Psilocybe cubensis spore syringes are 10 cc syringes filled in our ISO-7 cleanroom. Each one comes with a sterile needle. Orders placed by 1 p.m. Eastern on a weekday ship the same day, to the 46 states where spores are legal. You get free shipping on orders over $100, up to 40% off with our 3-, 5- and 10-packs, and a 30-day warranty. They are sold for microscopy and taxonomy use only.
