H.R. 4273119th CongressPlaced on the calendarLatest action Sep 17, 2025Decoded by AI · checked against the record
Official title: Over-the-Counter Monograph Drug User Fee Amendments
Introduced:
Read the official bill on Congress.govThe plain-language version leads. The official text is always the reference.
The bill renews FDA fees on OTC drugmakers through 2030 to fund safety and quality reviews.
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This bill renews and updates the FDA's OTC drug fee program, extending it through 2030. It updates fee schedules, adjusts inflation and cost formulas, sets specific funding amounts for certain years, and lets the FDA recognize modern voluntary industry testing standards without a lengthy formal process. It also extends FDA reporting requirements to Congress on fee use and pushes back deadlines to match the 2026–2030 timeframe.
Pharmaceutical and consumer health companies that make OTC drugs pay these fees. Consumers who buy OTC medicines are indirectly affected, since the fees fund FDA safety and quality oversight.
Without renewal, the fee program was set to expire, which would have affected FDA funding for reviewing OTC drug ingredients and manufacturing facilities. The changes adjust how much companies pay and when, and how the FDA verifies drug quality standards.
AI-drafted summary. Verify it against the official text before you act on it. Read the official bill on Congress.gov
Right now: it was placed on the House floor calendar, and the official record shows no floor action on it since. If the Senate changes it, it goes back to the House before reaching the President.
Latest action: — Placed on the Union Calendar, Calendar No. 254.