Over-the-Counter Monograph Drug User Fee Amendments
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Summary
This bill amends the Federal Food, Drug, and Cosmetic Act to revise and extend the user fee program for over-the-counter (OTC) monograph drugs through fiscal year 2030. It modifies fee assessment periods, establishes specific revenue targets for fiscal years 2026–2030, adjusts inflation calculations, and expands the definition of OTC monograph drug activities to include testing procedures based on voluntary consensus standards. The bill also adjusts fee due dates and operating procedures for the OTC monograph drug program administered by the FDA.
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