# 2025-23852: FDA Hikes Fees for OTC Drug Requests: Pay Up, Pharma!

2025-23852, Over-the-Counter Monograph Drug User Fee Amendments-OTC Monograph Order Request Fee Rates for Fiscal Year 2026, is a Federal Register notice from Health and Human Services Department, Food and Drug Administration published 2025-12-29, effective 2025-10-01 (as of 2026-06-08).

- Canonical: https://policyrisk.com/federal-register/2025-23852
- As of: 2026-06-08
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Document number: 2025-23852
- Title: Over-the-Counter Monograph Drug User Fee Amendments-OTC Monograph Order Request Fee Rates for Fiscal Year 2026
- Type: Notice
- Agencies: Health and Human Services Department; Food and Drug Administration
- Citation: 90 FR 60719
- Published: 2025-12-29
- Effective: 2025-10-01
- Comments close: not stated
- Significant: no
- Touches household money: no
- Regulation identifier numbers: none
- Last updated: 2026-06-08

## In one line

FDA Hikes Fees for OTC Drug Requests: Pay Up, Pharma!

## 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.

## Abstract

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 (OMOR)s for fiscal years 2026 through 2030. In this notice, FDA is announcing the OMOR fee rates for fiscal year (FY) 2026. FDA plans to announce the FY 2026 OMUFA facility fee rates, i.e., monograph drug facility (MDF) and contract manufacturing organization (CMO) facility fee rates, in a subsequent Federal Register notice (and anticipates its issuance will generally align with the timing of the OMUFA facility fee rate publication for prior FYs).

## Effects PRIA read

- Large OMOR Fees for FY2026: cost, high. 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: benefit, medium. 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 admini…
- How to Pay OMOR Fees and Limits: cost, low. 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…

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## Sources
- [2025-23852 on federalregister.gov](https://www.federalregister.gov/documents/2025/12/29/2025-23852/over-the-counter-monograph-drug-user-fee-amendments-otc-monograph-order-request-fee-rates-for-fiscal)
- [2025-23852 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2025-12-29/pdf/2025-23852.pdf)

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Source: PRIA, https://policyrisk.com/federal-register/2025-23852 (as of 2026-06-08).