Over-the-Counter Monograph Drug User Fee Rates for Fiscal Year 2027
Published Date: 7/30/2026
Notice
Summary
The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Over-the-Counter Monograph Drug User Fee Amendments (herein referred to as "OMUFA II"), authorizes the Food and Drug Administration (FDA, the Agency, or we) to assess and collect user fees from qualifying manufacturers of over-the-counter (OTC) monograph drugs and submitters of OTC monograph order requests (OMORs) for fiscal years 2026 through 2030. This notice publishes the OMUFA fee rates for fiscal year (FY) 2027.
Analyzed Economic Effects
6 provisions identified: 2 benefits, 3 costs, 1 mixed.
Annual Facility Fees for OTC Manufacturers
If you own an over-the-counter (OTC) monograph drug manufacturing facility, the FY 2027 annual facility fee is $47,891 for an OTC monograph drug facility (MDF) and $31,927 for a contract manufacturing organization (CMO) facility (CMO = two-thirds of MDF). These fees are effective October 1, 2026 through September 30, 2027 and are billed in two equal installments due October 1, 2026 and February 1, 2027.
Large Fees for OMOR Submissions
If you submit an OTC monograph order request (OMOR), the FY 2027 fee is $614,608 for a Tier 1 OMOR and $122,921 for a Tier 2 OMOR. OMOR fees are due on the date you submit the OMOR.
Fee Waiver for Safety-Related OMORs
No OMOR fee will be charged if the OMOR seeks certain safety-related changes: (1) changes to drug facts labeling that add or strengthen a contraindication, warning, or precaution; (2) statements about risk associated with misuse or abuse; or (3) dosage/administration instructions intended to increase safe use.
Who Is/Is Not an OMUFA Facility
Facilities that manufacture or process finished-dosage OTC monograph drugs (including relabelers and repackagers) are subject to OMUFA facility fees. Facilities that only manufacture active pharmaceutical ingredients (APIs), produce clinical research supplies, perform testing, or only place outer overpackaging on already final-packaged products are not considered OTC monograph drug facilities for FY 2027.
Payment Methods, Limits, and Collection Consequences
Payments must be in U.S. currency drawn on a U.S. bank via electronic check (ACH), credit card, or wire transfer using FDA's payment portal; credit card payment is available only for balances under $25,000 and ACH is required for larger balances. If an assessed FY 2027 fee is not paid in full, the unpaid balance will be treated as a U.S. Government claim and referred to collection.
Exemption If You Ceased OTC Activity Before Jan 1, 2026
A facility is exempt from FY 2027 facility fees if it ceased OTC monograph drug activities and updated its FDA registration to that effect prior to January 1, 2026.
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