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

Indivior Inc.

Data updated

Pharmaceutical company responsible for the U.S. SUBLOCADE REMS program, including enrollment, certified healthcare setting controls, and controlled dispensing requirements.

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 OversightData Reporting RequirementsCompliance Monitoring and Inspections

Framework / Program

SUBLOCADE REMS Program

Policy Notes

SUBLOCADE is distributed through a REMS with certification and controlled distribution requirements designed to mitigate serious harm risk and ensure monitored administration workflows.

Verification

Verified

Psychedelic Engagement

Psychedelic-Adjacent Focus

Framework Status

Active

Last Verified

Apr 8, 2026

Primary Policy Link

Source Evidence

SUBLOCADE REMS Program

https://www.sublocaderems.com/

FDA SUBLOCADE REMS Document

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209819Orig1s000Rems.pdf

FDA SUBLOCADE Prescribing Information

https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/209819s031lbl.pdf

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