FDA 2026: New OMUFA Program Fees and OTC Drugs

The US Food and Drug Administration (FDA) has published the applicable fees for fiscal year 2026 within the OMUFA (Over-the-Counter Monograph Drug User Fee Program), which affect both facilities that manufacture OTC drugs under a monograph and companies that request modifications to an existing monograph.

Companies operating in the US over-the-counter drug market must take these regulatory costs into account in their strategic planning.

Table of contents

1. What is the OMUFA program?

2. Annual fees for facilities that manufacture OTC drugs

3. OMOR fees for modifying an OTC monograph

FDA 2026: New OMUFA Program Fees and OTC Drugs

What is the OMUFA program?

The Over-the-Counter Monograph Drug User Fee Program (OMUFA) is the fee system established by the FDA to fund the management and modernization of the OTC monograph system.

OTC monographs define the conditions under which an over-the-counter drug can be marketed in the United States without prior NDA authorization, provided the product meets the following requirements:

• Permitted active ingredients

• Approved indications

• Established concentrations and pharmaceutical forms

• Labeling requirements

With the reform introduced by the CARES Act, companies can now request modifications or updates to these monographs through so-called OTC Monograph Order Requests (OMOR).

The OMUFA program primarily includes two types of regulatory fees :

1. Annual fees for facilities that manufacture OTC drugs under a monograph

2. Fees for monograph modification requests (OMOR)

Annual fees for facilities that manufacture OTC drugs

Facilities that manufacture or process OTC drugs under a monograph must pay a mandatory annual fee under the OMUFA program.

This obligation applies to:

• Facilities located in the United States

• Foreign facilities that manufacture OTC for the US market

It also includes contract manufacturers that produce OTC drugs for third parties.

The rates are divided into two main categories

1. Monograph Drug Facility (MDF)

   Facilities that manufacture OTC products under a monograph.

2. Contract Manufacturing Organization (CMO)

   Contract manufacturers that produce OTC products for other companies.

These fees are updated annually and are normally due during the month of June of each fiscal year.

Facility User Fee Rates	FY 2024	FY 2025
Monograph Drug Facility (MDF) Fee	$34,166	$37,556
Contract Manufacturing Organization (CMO) Fee	$22,777	$25,037

Paying these fees is mandatory to maintain the ability to manufacture OTC drugs for the US market. 

OMOR fees for modifying an OTC monograph

In addition to annual facility fees, companies must pay a fee when they file an OTC Monograph Order Request (OMOR).

An OMOR is used when a company requests the FDA to modify an existing monograph, for example to

• Add a new active ingredient

• Add a new indication

• Introduce new terms of use

• Modify dosages or pharmaceutical forms

For fiscal year 2026, the FDA has established the following rates

• Tier 1 OMOR: approximately $587,000

• Tier 2 OMOR: approximately $117,000

• Tier 1 applications typically involve significant changes to the monograph, such as the introduction of new active ingredients or indications.

• Tier 2 requests correspond to minor modifications.

• The OMOR fee must be paid at the time of submitting the application to the FDA.

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