FY 2025 OMUFA Fees - FDA Registration Fees

FDA OTC Monograph Drug registration fee for 2025 is $37,556 for the MDF Facility and $25,037 for the CMO Facility.

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

OTC monograph drug facility fees for FY 2025 (2025 OMUFA Fees) are due on Monday, June 2, 2025.

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

Type of Registration / Application

MDF Facility

CMO Facility

OTC Monograph Drug Facility (OMUFA) Fee

$37,556

$25,037

Type of Application

OMOR Fee

OMOR Fee Tier 1

$559,777

OMOR Fee Tier 2

$111,955


The FY 2025 OMUFA fee does not apply to the below facilities

  • Facilities that only manufacture the active pharmaceutical ingredient (or API) of an OTC monograph drug, which do not meet the definition of an OTC monograph drug facility under the FD&C Act.
  • OTC monograph drug facilities that had ceased all activities related to OTC monograph drugs prior to December 31, 2023, and had updated their registration with the FDA to reflect that change.
  • Entities that registered with the FDA during the Coronavirus Disease 2019 (COVID-19) pandemic whose sole activity with respect to OTC monograph drugs during the pandemic consisted of manufacturing OTC hand sanitizer products and had ceased manufacturing hand sanitizer products and delisted and deregistered with the FDA accordingly before 12 a.m. EST on December 31, 2024.

Understanding OTC Monograph Terms

  • An OTC monograph drug (OTC Drug) is a nonprescription drug without an approved new drug application.
  • An OTC monograph drug facility (MDF) is a foreign or domestic business or other entity that, in addition to meeting other criteria, 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 affiliate of the owner or facility sells the OTC monograph drug produced at such facility directly to wholesalers, retailers, or consumers
  • The term "OTC monograph order request" (or OMOR) is defined in section 744L(7) of the FD&C Act and refers to a request for FDA to issue an administrative order under section 505G of the FD&C Act.

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