HR. 4273Introduced

Over-the-Counter Monograph Drug User Fee Amendments

Reauthorizes the over-the-counter monograph drug user fee program through FY2030 and updates fee amounts, deadlines, and eligible order requests

What this bill does

Reauthorizes the over-the-counter monograph drug user fee program through FY2030 and updates fee amounts, deadlines, and eligible order requests

Key points
  • Require advance publication of fees
  • Modify facility fee amounts
  • Allow Tier 2 testing procedure requests
  • Extend OMUFA

Where it stands

Status
Introduced
Latest action
2025-09-17Placed on the Union Calendar, Calendar No. 254.

Topics and policy areas

undefinedCongressional oversightDrug safety, medical device, and laboratory regulationHealthUser charges and fees