FDA Implements Split Payment Framework for FY 2027 OTC Monograph Facility Fees

by | Oct 13, 2026 | FDA

The U.S. Food and Drug Administration (FDA) has established a two-part installment plan for Fiscal Year (FY) 2027 Over-the-Counter (OTC) monograph drug facility user fees. Under this payment schedule, regulated drug establishments must remit their annual facility fees in two equal portions rather than a single lump sum.

Critical Payment Deadlines:

Drug facility owners and regulatory compliance teams should align their accounting schedules to meet the upcoming OMUFA deadlines:

  • Initial Payment (50%): The first half of the facility assessment is due on October 1, 2026.
  • Final Payment (50%): The concluding 50% balance must be settled by February 1, 2027.

This split-fee structure reflects a key administrative transition under the Over-the-Counter Monograph Drug User Fee Program (OMUFA). Historically, OTC facility fees were payable later in the calendar year (typically June 1). To harmonize OMUFA collection timelines with the start of the federal fiscal year on October 1 alongside other FDA user fee programs (such as PDUFA and GDUFA), the agency adopted this installment approach during FY 2027 to mitigate immediate budgetary impacts on registrants.