S 2292
Over-the-Counter Monograph Drug User Fee Amendments
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Sign in to take action- Introduced
- Passed Senate
- Passed House
- To President
- Became Law
Bill overview
This bill reauthorizes the Over-the-Counter (OTC) Monograph Drug User Fee Program (OMUFA), which provides funding for the FDA to evaluate topical, nonprescription drugs. It revises how fees are collected and calculated, extending the program through fiscal year 2030. The bill also requires the FDA to clarify the process for switching prescription drugs to nonprescription status, including using real-world evidence and engaging with stakeholders, and mandates a GAO report on the OTC monograph drug supply chain and the FDA’s drug switching process.
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