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HF 383

A bill for an act relating to the controlled substance crystalline polymorph psilocybin.

2025-2026 Regular Session

HF 383 would have immediately removed an FDA‑approved crystalline psilocybin formulation from Iowa Schedule I and allowed prescribing and distribution after federal rescheduling.

Vetoed by Governor.
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Bill Summary · HF 383

Summary — HF 383 (2025): Crystalline polymorph psilocybin (COMP 360)

Overview / Purpose

HF 383 would have created a state-level exception for an FDA‑approved pharmaceutical formulation of crystalline polymorph psilocybin (commonly referenced as COMP 360 or any FDA‑approved trade name). The bill’s intent was to remove that specific FDA‑approved psilocybin product from Iowa’s Schedule I list immediately upon FDA approval and to allow its prescribing, distribution, and marketing after it is rescheduled at the federal level.

Key provisions

  • Adds a new subsection to Iowa Code section 124.201 to treat an FDA‑approved pharmaceutical composition of crystalline polymorph psilocybin (COMP 360 or other FDA trade name) differently from currently scheduled psilocybin.
  • Specifies that, notwithstanding the state scheduling provision (section 124.204, subsection 4), a drug containing that pharmaceutical composition:
    • Shall be immediately removed from Iowa Schedule I upon approval by the U.S. Food and Drug Administration (FDA).
    • Shall be rescheduled under state law in accordance with the recommendations of the FDA and the drug’s listing under the federal Controlled Substances Act (21 U.S.C. §812) and federal regulations (21 C.F.R. §1308.14).
  • Provides that immediately upon the federal rescheduling referenced above, it would be lawful in Iowa to prescribe, distribute, and market the FDA‑approved crystalline polymorph psilocybin product.

Who or what would be affected

  • Patients: Individuals eligible under the FDA‑approved indication(s) for the drug could access it through prescription once the product is FDA‑approved and rescheduled federally.
  • Healthcare providers and pharmacies: Would be permitted to prescribe, dispense, and market the specific FDA‑approved psilocybin formulation once federal rescheduling occurs.
  • Drug manufacturers and distributors: Companies manufacturing or marketing COMP 360 (or an FDA‑approved trade name) would be able to operate in Iowa following FDA approval and federal rescheduling.
  • State law enforcement and regulatory bodies: Would need to update state controlled‑substances scheduling and enforcement to reflect federal action for that specific product.

Note: The bill applies only to the specified pharmaceutical composition approved by the FDA and rescheduled at the federal level; it does not decriminalize or reschedule all psilocybin-containing materials or formulations.

Procedural history and status

  • Introduced: February 13, 2025 (House File 383).
  • House passage: February 20, 2025 — yeas 92, nays 0.
  • Senate passage: April 16, 2025 — yeas 47, nays 0.
  • Enrolled and sent to Governor: May 19, 2025.
  • Governor action: Vetoed by the Governor on June 11, 2025.
  • Current status: Vetoed — the bill did not become law unless the General Assembly subsequently overrides the veto.

Potential impacts and considerations

  • Administrative alignment with federal decisions: The bill would have created an automatic state response to FDA approval and federal rescheduling, avoiding a separate state scheduling process for that specific product.
  • Access to an FDA‑approved psilocybin medicine: If COMP 360 receives FDA approval and is rescheduled federally, HF 383 would have allowed timely access in Iowa through medical channels.
  • Limited scope: By tying the change to a specific crystalline polymorph formulation and to FDA approval/rescheduling, the bill minimizes broader legal changes to other psilocybin forms or non‑FDA products.
  • Implementation mechanics: State agencies (public health, controlled substances regulators, licensing boards) would need to update rules and guidance upon federal action.

Next steps (procedural)

Because the Governor vetoed HF 383 on June 11, 2025, the bill did not become law. The General Assembly could attempt a veto override (requiring the constitutionally required supermajority) or could reintroduce similar legislation in a future session.

Compiled from official sources — confirm details with the bill’s official record.

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