FDA Hikes Fees for OTC Drug Requests: Pay Up, Pharma!
Published Date: 12/29/2025
Notice
Summary
Starting October 1, 2025, companies that make or request orders for over-the-counter (OTC) drugs will pay new fees to the FDA for fiscal year 2026. These fees help the FDA keep OTC drugs safe and effective. If you’re a manufacturer or submitter, get ready for updated costs that will last through September 30, 2026.
Analyzed Economic Effects
3 provisions identified: 1 benefits, 2 costs, 0 mixed.
Large OMOR Fees for FY2026
If you submit an Over-the‑Counter Monograph Order Request (OMOR), you must pay a fee when you file. For fiscal year 2026 (October 1, 2025 through September 30, 2026) the fee is $587,529 for a Tier 1 OMOR and $117,505 for a Tier 2 OMOR, and the fee is due on the date you submit the OMOR.
Fee Exemption for Safety Labeling Changes
You will not be charged an OMOR fee if your request only seeks certain safety-related labeling changes. No fee applies when the OMOR would add or strengthen (1) a contraindication, warning, or precaution; (2) a statement about risk from misuse or abuse; or (3) an instruction about dosage and administration intended to increase safe use.
How to Pay OMOR Fees and Limits
To pay, complete the OTC Monograph User Fee Cover Sheet to get a user fee ID and pay in U.S. currency drawn on a U.S. bank by electronic check (ACH) or wire transfer; Pay.gov (ACH/eCheck) is the preferred online method. Only full payments are accepted online; credit card payment is allowed only for balances under $25,000. Include the user fee ID on wire transfers so FDA can apply your payment.
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Key Dates
Department and Agencies
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