Freedom to Heal Act of 2025
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Progress
Where this bill stands in the legislative process.
- Introduced
- Passed Senate
- Passed House
- To President
- Became Law
Overview
The Freedom to Heal Act of 2025 creates a special registration process under the Controlled Substances Act to allow physicians to directly administer schedule I investigational drugs to patients under the Federal Right to Try law. This registration requires physicians to demonstrate qualifications, secure agreements from drug manufacturers, and adhere to specific storage and handling requirements. The Attorney General will review applications and issue registrations or orders to show cause, with provisions for electronic submissions and limitations on drug quantities.
Key provisions
- Establishes a special registration for schedule I investigational drugs under the Federal Right to Try law.
- Requires physicians to demonstrate valid controlled substance registration and compliance with the Federal Food, Drug, and Cosmetic Act.
- Mandates agreements with manufacturers or sponsors for drug supply and administration guidance.
- Limits the amount of investigational drug a physician can possess based on application and supplemental notifications.
- Allows physicians to treat patients across multiple sites within the same city or county under a single registration.
- Requires the Attorney General to issue interim and final rules to implement the registration process.
- Provides a mechanism for electronic application submissions.
- Establishes a timeline for the Attorney General to issue interim final and final rules.
Who is affected
Bill text
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Sponsors
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3 on record
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