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  1. FDA User Fee Programs

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


A resource for the public to view OTC Monographs and their Administrative Orders (Proposed, Final, and Interim Final). OTC Monographs@FDA also facilitates the ability for the public to submit, search, and view comments and data for Proposed and Interim Final Administrative Orders, except if otherwise specified.

Latest News

  • On March 24, 2023, FDA announced the rates for over-the-counter (OTC) monograph drug user fees for fiscal year (FY) 2023 in a Federal Register Notice (FRN) titled “Over-The-Counter Monograph Drug User Fee Rates for Fiscal Year 2023.” This FRN publishes fees for OTC monograph drug facilities and OTC Monograph Order Requests (OMORs) for FY 2023.
  • To calculate the facility fee rates, in accordance with our statutory authority, FDA bases its calculations on factors for each fiscal year 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. FDA recognizes that the FY 2023 facility fee rates are an increase of 8 percent in comparison to the FY 2022 facility fee rates and this increase is largely attributed to the increases in the total target revenue due to inflation and other adjustments and the change in the FY 2023 MDF to CMO ratio to 60:40 from the FY 2022 ratio of 65:35.
  • On November 2, FDA issued a draft guidance for industry titled “Assessing User Fees Under the Over-the-Counter Monograph Drug User Fee Program.” The draft guidance provides stakeholders with information regarding FDA’s implementation of the OMUFA user fee program.

Fiscal Year (FY) 2023 User Fee Rates

FY 2023 Facility User Fee Rates
Monograph Drug Facility (MDF) Facility Fee $26,153
Contract Manufacturing Organization (CMO) Facility Fee $17,435
FY 2023 OMOR Fee Rates
Tier 1 $517,381
Tier 2 $103,476

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