Month: April 2025

OMUFA FY 2025

OMUFA for FY 2025 gives out fees for facilities and OTC Monograph Order Requests (OMORs), in effect from October 1, 2024, through September 30, 2025.​

OTC Monograph Drug facilities registered with FDA from January 1, 2024, through December 31, 2024, are liable for the FY 2025 FDA fees.

FDA Fees for OTC Monograph Drug Facility Registration for Fiscal Year 2025

Type of Registration / Application MDF Facility CMO Facility
OTC Monograph Drug Facility Fee (OMUFA) $37,556 $25,037

The above fees are applicable to the establishment manufacture or processing the finished dosage form of an OTC drug.

This fee must be paid by Monday June 2nd, 2025.

Payment is due within twenty calendar days of the original due date, and it must be paid in US dollars either by electronic check or wire transfer.

Applicable wire transfer fees must be included with payment to ensure fees are fully paid.

The consequences of arrear payments are as below.

  1. The facility will be placed on the arrears list.
  2. OTC drug manufactured in such facilities will be considered misbranded and the company will be placed FDA’s arrears list.
  3. An OMOR submitted by a person subject to fees shall be considered incomplete and not be accepted for filing until all fees owed by such person have been paid.
  4. A person subject to fees shall be considered ineligible for OTC monograph drug meetings until they have paid the fees.

Liberty Management Group Ltd, a leading FDA consulting group provides assistance with OMUFA PIN creation, API drug establishment registration, Drug establishment registration and listing renewals and US agent service to foreign countries.

Sudha S

Regulatory Consultant

Email: Office@libertymanagment.us

www.fdahelp.us

OMUFA OVERVIEW

According to CARES Act, the Over-the-Counter Monograph Drug User Fee Program (OMUFA) is a program implemented by the U.S. Food and Drug Administration (FDA) to help fund the regulation of over the counter (OTC) drug products. The program aims to expedite the review and approval process for OTC drugs and improve the safety and availability of OTC products.

OMUFA’s goal is to provide the FDA with the necessary resources to evaluate, approve, and regulate new or modified OTC drug products more efficiently. It helps cover the costs of the FDA’s review activities, which are critical to ensuring the safety and effectiveness of OTC medications.

FDA has introduced two types of fees.

  1. Establishment/Facility fees
  2. OTC Monograph Order Request (OMOR) fees

Companies that wish to introduce a new OTC drug or update existing OTC monographs must pay user fees to the FDA.

OTC drugs are that products that fall under FDA’s OTC monograph which does not require FDA approval and can be marketed without a prescription. OMUFA was created to support the process of revising the monographs and reviewing drug products.

Manufacturers can submit new OTC drug products or requests for changes to the FDA’s existing monographs. These submissions are subject to review, and manufacturers must pay the applicable user fees.

OTC monograph drug facility (MDF) is a foreign or domestic establishment that is engaged in manufacturing or processing the finished dosage form of an OTC monograph drug.

A contract manufacturing organization (CMO) facility is an OTC monograph drug facility where neither the owner nor any affiliated partner or the establishment sells the OTC monograph drug produced at such facility directly to wholesalers, retailers, or consumers in the United States.

FDA Fees for OTC Monograph Drug Facility Registration for Fiscal Year 2025

Type of Registration / Application MDF Facility CMO Facility
OTC Monograph Drug Facility Fee                 $37,556 $25,037

The following are the facilities that does not need to pay OMUFA for FY 2025.

  • API manufacturer of OTC monograph drug
  • OTC monograph drug facilities that had stopped all activities related to OTC monograph drugs prior to December 31, 2023, and had de-registered and de-listed their drugs.
  • Drug establishment registered during pandemic period whose sole activity with respect to OTC monograph drugs consisted of manufacturing OTC hand sanitizer products and has stopped manufacturing hand sanitizer products and delisted and deregistered with the FDA on or before on December 31, 2024.
  • Animal Drug manufacturers
  • Homeopathic drug manufacturers.

Liberty Management Group Ltd, a leading FDA consulting group provides assistance with OMUFA PIN creation, API drug establishment registration, Drug establishment registration and listing renewals and US agent service to foreign countries.

Sudha S

Regulatory Consultatnt

Email : office@libertymanagement.us

www.fdahelp.us