S 2292 United States Senate · 119th Congress

Over-the-Counter Monograph Drug User Fee Amendments

This bill establishes a user fee system for facilities that manufacture over-the-counter (OTC) monograph drugs. It requires these facilities to pay annual fees to the FDA starting in fiscal year 2026, with specific fee amounts set for 2026-2030 ($2.37 million in 2026, decreasing to $854,000 in 2028). The fees will be adjusted annually for inflation and include additional adjustments based on facility workload and other factors. The system will expire on October 1, 2030, with detailed payment schedules and deadlines specified in the legislation.

Bill status in committee 1 of 4 stages cleared

Introduction

Jul 2025

Committee Review

Floor Vote

President

Introduced Jul 15, 2025 Last action Sep 8, 2025

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Full legislative history

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Committee

Sep 8, 2025

Upper · Passed

Committee on Health, Education, Labor, and Pensions. Reported by Senator Cassidy with an amendment in the nature of a substitute. Without written report.

upper

Jul 30, 2025

Upper · Passed

Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.

upper

Jul 15, 2025

Committee

Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

upper

Jul 15, 2025

Introduced

Introduced in Senate

upper

1 primary · 3 co-sponsors