S. 2292Introduced
Over-the-Counter Monograph Drug User Fee Amendments
Reauthorizes FDA over the counter monograph user fees through FY2030 while updating review procedures for topical nonprescription drugs and clarifying prescription to nonprescription switch applications
Plain-English overview
What this bill does
Reauthorizes FDA over the counter monograph user fees through FY2030 while updating review procedures for topical nonprescription drugs and clarifying prescription to nonprescription switch applications
Key points
- Require FDA switch guidance
- Modify OTC fee calculations
- Extend OMUFA fees
- Review switch handling and supply chain
Current status
Where it stands
Status
Introduced
Latest action
2025-09-08 — Placed on Senate Legislative Calendar under General Orders. Calendar No. 152.
Related context
Topics and policy areas
undefinedCongressional oversightDrug safety, medical device, and laboratory regulationHealthSupply chainUser charges and fees