FDA OTC Monograph Drug Fees 2023 — Historical Reference

Historical OMUFA fees for 2023. .

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FY 2023 - FDA OTC Monograph Drug Facility Registration Fees

FDA OTC Monograph Drug registration fee for the year 2023 is USD 26,153 for MDF Facility and USD 17,435 for CMO Facility.

OTC Monograph Drug facilities registered with FDA from January 1, 2022, through December 31, 2022, are liable for the FY 2023 FDA fees.

FDA fiscal year 2023 starts on October 1, 2022, and ends on September 30, 2023. The annual establishment registration fee must be paid via the FDA user fee system. OTC monograph drug facility fees for FY 2023 are due June 1, 2023.

FDA Fees for OTC Monograph Drug Facility Registration for Fiscal Year 2023

Type of Registration / Application	MDF Facility	CMO Facility
OTC Monograph Drug Facility (OMUFA) Fee	$26,153	$17,435

Type of Application	OMOR Fee
OMOR Fee Tier 1	$517,381
OMOR Fee Tier 2	$103,476

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 engages in manufacturing or processing the finished dosage form of an OTC monograph drug and sells the OTC monograph drug directly to wholesalers, retailers, or consumers.
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.