Over-the-Counter Monograph Drug User Fee Amendments

This bill creates a user fee system for facilities that manufacture over-the-counter (OTC) monograph drugs, which are medications generally recognized as safe and effective. The fees will be assessed for fiscal years 2026 through 2030, with specific payment schedules and revenue targets that account for inflation and other factors. The bill requires the Secretary of Health and Human Services to report on the use of these fees annually. The fee system will end on October 1, 2030, with reporting requirements continuing until January 31, 2031.