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Extending OTC Drug User Fees: Funding FDA Oversight and Quality Standards.

This Act extends and revises the user fee program for manufacturers of over-the-counter (OTC) monograph drugs until 2030. These funds are dedicated to the Food and Drug Administration (FDA) activities related to ensuring the safety and quality of non-prescription medicines. The goal is to secure stable funding for regulatory oversight, which helps maintain high standards for the common drugs consumers purchase.
Key points
The fee program for OTC drug manufacturers is reauthorized through Fiscal Year 2030, securing dedicated funding for FDA regulatory activities.
New deadlines and fee structures are established for pharmaceutical facilities, including splitting payments for Fiscal Year 2027 and introducing workload-based adjustments.
The FDA can more easily adopt updated testing procedures for OTC drugs based on recognized national or international quality standards.
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Status: Placed on Calendar
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Additional Information
Print number: 119_HR_4273
Sponsor: Rep. Latta, Robert E. [R-OH-5]
Process start date: 2025-07-02