HR. 4273Introduced
Over-the-Counter Monograph Drug User Fee Amendments
Reauthorizes the FDA over-the-counter monograph drug user fee program through FY2030 and updates fee amounts, deadlines, and eligible order requests
Plain-English overview
What this bill does
Reauthorizes the FDA over-the-counter monograph drug user fee program through FY2030 and updates fee amounts, deadlines, and eligible order requests
Key points
- Require advance fee publication
- Modify facility fee amounts
- Allow Tier 2 testing requests
- Extend OMUFA
Current status
Where it stands
Status
Introduced
Latest action
2025-09-17 — Placed on the Union Calendar, Calendar No. 254.
Related context
Topics and policy areas
undefinedCongressional oversightDrug safety, medical device, and laboratory regulationHealthUser charges and fees