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Government, Policy & Advocacy
Government, Policy & Advocacy
Regulation & EnforcementREMS Administrators

TIRF REMS Access Program

Data updated

U.S. shared-system REMS program for transmucosal immediate-release fentanyl products, maintaining restricted prescriber, pharmacy, and patient enrollment controls.

Regulation & Enforcement Snapshot

REMS Administrators

Authority Type

REMS Program Administrator

Jurisdiction

National

Coverage

1 country

Binding Strength

Programmatic Requirement

Function Areas

Risk Evaluation and Mitigation OversightControlled Substance Program OversightCompliance Monitoring and Inspections

Framework / Program

TIRF Medicines Shared System REMS

Policy Notes

FDA approved discontinuation of active TIRF REMS activities while preserving the REMS framework in place for any products that remain approved, reflecting a transitioned/sunset operational state.

Verification

Verified

Psychedelic Engagement

No Public Psychedelic Focus

Framework Status

Sunset / Inactive

Last Verified

Apr 8, 2026

Primary Policy Link

Source Evidence

FDA Q&A - TIRF Medicines Class REMS Discontinuation Notice

https://www.fda.gov/drugs/information-drug-class/questions-and-answers-fda-approves-class-risk-evaluation-and-mitigation-strategy-rems-transmucosal

TIRF REMS Access Program

https://www.tirfremsaccess.com/

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