FY 2022 - FDA OTC Monograph Drug Facility Registration Fees

FDA OTC Monograph Drug registration fee for the year 2022 is USD 24,178 for MDF Facility and USD 16,119 for CMO Facility.

FDA fiscal year 2022 starts from October 1, 2021 and ends on September 30, 2022. Annual establishment registration fee must be paid via FDA user fee system. OTC monograph drug facility fees for FY 2022 are due June 1, 2022.

FDA Fees for OTC Monograph Drug Facility Registration for Fiscal Year 2022

Type of Registration / Application

MDF Facility

CMO Facility

OTC Monograph Drug Facility Fee

$24,178

$16,119

Type of Application

OMOR Fee

OMOR Fee Tier 1

$507,021

OMOR Fee Tier 2

$101,404

  • 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.

Source:Federal Register

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