On March 18, 2026, the U.S. Food and Drug Administration announced the over-the-counter (OTC) Monograph Drug facility fee rates for fiscal year (FY) 2026 in a Federal Register notice (FRN) titled “Over-the-Counter Monograph Drug Facility Fee Rates for Fiscal Year 2026.”
This FRN publishes annual OMUFA fees for OTC monograph drug facilities for FY 2026 (October 1, 2025 – September 30, 2026) and includes information about facility fee calculations, fee due dates, and fee payment procedures. The FY 2026 facility fee rates are shown below, and the fees are due by June 1, 2026.
FY 2026 Facility User Fee Rates | |
Monograph Drug Facility (MDF) Fee | $19,188 |
Contract Manufacturing Organization (CMO) Fee | $12,792 |
The FY 2026 facility fee rates decreased when compared to the FY 2025 facility fee rates. FDA calculates fees in accordance with our statutory authority, considering factors that include the 1) number of fee-liable facilities, 2) ratio of monograph drug facilities (MDF) to contract manufacturing organizations (CMO), and 3) increases in the total target revenue due to inflation and other adjustments.
This year’s facility fee reflects a decrease of 49% compared to the FY 2025 fee amount. This decrease is largely due to FDA applying a downward operating reserve adjustment. The FRN describes the fee calculations in detail.
This notice publishes the OMUFA facility fee rates for FY 2026. The over-the-counter monograph order request (OMOR) fee rates for FY 2026 were published on December 29, 2025.
For more information on the facility fee rates, please refer to the FRN or FDA’s Over-the-Counter Monograph Drug User Fee Program (OMUFA) webpage.
