By Cassie Bumbaugh
Last updated on August 4, 2026
On July 30, 2026, the U.S. Food and Drug Administration (FDA) announced the Fiscal Year (FY) 2027 facility fees under the Over-the-Counter Monograph Drug User Fee Program (OMUFA). These annual fees are required for qualifying persons who own an OTC monograph drug facility, including contract manufacturing organization (CMO) facilities. For FY 2027, the Monograph Drug Facility (MDF) fee is $47,891, while the Contract Manufacturing Organization (CMO) fee is $31,927 (see the updated fee comparison chart below). The official Federal Register Notice was published on July 30, 2026, and details the methodology used to calculate this year’s fees, including facility counts, estimated program costs, and the operating reserve adjustment.
*Screenshot from FDA website
OMUFA facility fees are payable in two installments: 50% is due on October 1, and the remaining 50% is due on February 1, 2027. FDA will not send an invoice prior to the due date. To pay your OMUFA fees, follow the instructions on the FDA’s OTC OMUFA Monograph Facility Fee Cover Sheet Creation Process: Step-by-Step Instructions. Facility owners should complete the OMUFA Facility Fee Cover Sheet and submit payment electronically. FDA accepts payment by electronic check (Automated Clearing House (ACH) also known as eCheck), credit card, or wire transfer. Paper-based payments are no longer accepted.
The SRC team is available to help you achieve and maintain compliance for your over-the-counter drug products. Please contact your SRC consultant if you have any questions or would like assistance with payment processing.
