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  1. FDA User Fee Programs

Over-The-Counter Monograph User Fee Program (OMUFA)

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FDA updated and reissued the rates for over-the-counter (OTC) monograph Drug User Fees for fiscal year (FY) 2021 in a Federal Register Notice (FRN) titled “Fee Rates under the Over-The-Counter Monograph Drug User Fee Program for Fiscal Year 2021.” This FRN announces fees established under the Federal Food, Drug, and Cosmetic (FD&C) Act with respect to OTC monograph drug facilities and OTC Monograph Order Requests (OMORs) for FY 2021. OTC monograph drug facility fees for FY 2021 will be due on May 10, 2021, 45 days after publication of this FRN. FDA also posted an FDA-In-Brief about this action.

As of April 30, 2021, FDA has not yet issued invoices to individual companies for FY 2021 facility fees under the Over-the-Counter Monograph Drug User Fee Program (OMUFA).  Prior to the due date for the FY 2021 OMUFA facility fee (May 10, 2021), we understand that some firms have received invoices from at least one third party billing company.  These invoices are not from FDA and are not required for payment.  If you pay directly with FDA per the instructions in the March 26, 2021, FRN, FDA does not charge handling fees or additional service fees. If you have questions, please email CDERCollections@fda.hhs.gov or call 301-796-7900.​

Fiscal Year (FY) 2021 User Fee Rates

FY 2021 Facility User Fee Rates
Monograph Drug Facility (MDF) Facility Fee $20,322
Contract Manufacturing Organization (CMO) Facility Fee $13,548
FY 2021 OMOR Fee Rates
Tier 1 $500,000
Tier 2 $100,000


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