United States (federal)
Psilocybin is illegal in the United States (federal) as of 31 Jul 2026. Schedule I nationwide; state-licensed programs operate under state law only.1
- Checked against 2 cited sources at this review.
1. What the law is
Controlled Substances Act, Pub. L. 91-513, Title II (1970); 21 U.S.C. 812, Schedule I(c)(15) (psilocybin) and I(c)(16) (psilocyn); implemented at 21 C.F.R. 1308.11(d)(29) and (d)(30)1
One date carries the whole federal position: 1 May 1971, when the Controlled Substances Act took effect and put psilocybin and psilocyn, spelled psilocin outside the statute, in Schedule I. That is the most restrictive category the statute has, reserved for substances it treats as having a high potential for abuse and no currently accepted medical use. Making, holding or distributing psilocybin is a federal crime in every state, district and territory, and there is no FDA-approved psilocybin product. Six federal actions were recorded in 2026: one executive order, three Food and Drug Administration actions, one Drug Enforcement Administration order, and one request for information from the Health Resources and Services Administration. None of them changed the legal status of psilocybin, and the early access route the executive order called for has not been set up.
2. Pending legislation
Introduced but not yet law. If a bill passes, this record changes with it.
H.R. 9559 (IBOGAINE Act), introduced 30 Jun 2026 and referred to the Subcommittee on Health on 17 Jul 2026. It does not name psilocybin, but would require rescheduling proceedings for any Schedule I drug that completes Phase 3 trials for a serious mental health disorder, and would streamline DEA quota revisions following FDA approval or breakthrough therapy designation.
3. History
The laws behind today’s status, when each took effect, and every review since, in order.
Illegal status takes effect.
Psilocybin and psilocyn became Schedule I controlled substances when the Controlled Substances Act took effect on 1 May 1971 (21 U.S.C. 812).
The DEA set the quantities of psilocybin and psilocyn that registered researchers and manufacturers may legally produce in the United States during 2026 (91 FR 287).
The President signed Executive Order 14401, directing the FDA and the Drug Enforcement Administration to speed up psychedelic drug review, build an early access route for seriously ill patients, and consider rescheduling once a drug finishes Phase 3 trials. As of this review the access route has not been set up (91 FR 21709).
The FDA issued three national priority vouchers to psychedelic drug programs, two of them for psilocybin. A voucher speeds up FDA review; it does not approve a drug or change its legal schedule (24 Apr 2026).
The FDA issued final guidance on how psychedelic drugs should be studied in clinical trials, replacing the draft it published in 2023. Guidance sets out what the agency expects; it does not carry the force of law (91 FR 43101).
The FDA set a public hearing on the possible future medical use of psychedelic drugs for 14 Sep 2026 and began taking written comments. Anyone wanting to attend or ask to speak must register by 21 Aug 2026 (91 FR 43095).
The Health Resources and Services Administration asked the public how psychedelic treatments should be staffed and delivered in outpatient clinics if any are ever approved, with comments closing 13 Aug 2026 (91 FR 43103).
Sources and confidence
Every status line is checked against the primary sources below. How each record is graded for confidence is set out in the methodology.
- 1.govinfo.gov (opens in new tab) · govinfo.gov
- 2.federalregister.gov (opens in new tab) · federalregister.gov
Cited at the review
This information is for educational purposes only and does not constitute legal advice. Laws change frequently, and enforcement practice can differ from the letter of the law. Verify current status with local authorities before relying on this record.
Changes to this record
Every change we have made to this record, dated, corrections included. Nothing changes silently.
The Health Resources and Services Administration asked the public how psychedelic treatments should be staffed and delivered in outpatient clinics if any are ever approved, with comments closing 13 Aug 2026 (91 FR 43103).
The FDA set a public hearing on the possible future medical use of psychedelic drugs for 14 Sep 2026 and began taking written comments. Anyone wanting to attend or ask to speak must register by 21 Aug 2026 (91 FR 43095).
The FDA issued final guidance on how psychedelic drugs should be studied in clinical trials, replacing the draft it published in 2023. Guidance sets out what the agency expects; it does not carry the force of law (91 FR 43101).
The FDA issued three national priority vouchers to psychedelic drug programs, two of them for psilocybin. A voucher speeds up FDA review; it does not approve a drug or change its legal schedule (24 Apr 2026).
The President signed Executive Order 14401, directing the FDA and the Drug Enforcement Administration to speed up psychedelic drug review, build an early access route for seriously ill patients, and consider rescheduling once a drug finishes Phase 3 trials. As of this review the access route has not been set up (91 FR 21709).
The DEA set the quantities of psilocybin and psilocyn that registered researchers and manufacturers may legally produce in the United States during 2026 (91 FR 287).
Psilocybin and psilocyn became Schedule I controlled substances when the Controlled Substances Act took effect on 1 May 1971 (21 U.S.C. 812).
United States (federal): psilocybin legal status. The Psilocybin Record. Accession US-001. Status as of 31 Jul 2026. https://psilocybinlegalization.com/record/federal
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