FY 2021 - FDA OTC Monograph Drug Facility Registration Fees



FDA Cancelled the Over-the-Counter Monograph Drug User Fee Program for Fiscal Year 2021 as per the new federal register notice. FDA will not collect the below fees until further notice

FDA OTC Monograph Drug registration fee for the year 2021 is USD 14,060 for MDF Facility and USD 9,373 for CMO Facility. The facilities exempted from OTC Monograph drug facility fee are

  • Active Pharmaceutical Ingredient (API) Manufacturing facilities
  • Production facility of clinical research supplies
  • Testing facilities
  • Facility activity is only placement of outer packaging on packages containing multiple finished products (Drug kits)

FDA fiscal year 2021 starts from October 1, 2020 and ends on September 30, 2021. Annual establishment registration fee must be paid via FDA user fee system within 45 days after the date of publication OTC Monograph Drug Fee Notice (Publication Date: December 29, 2020).

FDA Fees for OTC Monograph Drug Facility Registration for Fiscal Year 2021

Type of Registration / Application

MDF Facility

CMO Facility

OTC Monograph Drug Facility Fee

$14,060

$9,373

Type of Application

OMOR Fee

OMOR Fee Tier 1

$500,000

OMOR Fee Tier 2

$100,000

  • 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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