FDA Announces Fiscal Year 2026 OMOR Fee Rates: Costs to Increase

by | Feb 13, 2026 | FDA, OTC Drugs, U.S. Regulatory

The U.S. Food and Drug Administration (FDA) has officially released the fee rates for Over-the-Counter (OTC) Monograph Order Requests (OMOR) for the upcoming Fiscal Year (FY) 2026. As the OTC landscape continues to evolve under the CARES Act reforms, manufacturers and sponsors planning to submit monograph order requests must prepare for an increase in regulatory fees across both tiers.

The Numbers at a Glance

For FY 2026, the FDA has adjusted fees upward, reflecting an approximate 4.9% increase compared to the previous fiscal year.

Tier 1:

FY2026 – $587,529

(FY2025 was $559,777)

Tier 2:

FY2026 – $117,505 (FY2025 was $111,955)