On March 14, 2022, the U.S Food and Drug Administration (FDA) has announced the rates for over the counter (OTC) monograph drug user fees for fiscal year (FY) 2022 in a Federal Register Notice (FRN) titled ‘Over-The-Counter Monograph Drug User Fee Rates for FY 2022”. The FRN includes information about facility fee calculations, OMOR fee calculations, fee due dates, and payment options.

Spoiler alert: The FY 2022 facility fees rates are an increase of approx. 19% in comparison to the FY 2021 facility fee rates.

Application fees are as follows:

  • Monograph Drug Facility (MDF) Facility Fee – USD 24,127
  • Contract Manufacturing Organization (CMO) Facility Fee – USD 16,119

The fees also apply to the submitter of OTC Monograph Order Request (OMOR) and is as follows:

  • Tier 1 Monograph Fee – USD 507,021
  • Tier 2 Monograph Fee – USD 101,404

The OTC monograph drug facility fees are due on June 1, 2022.

If you need any assistance or have any questions related to whether this fee program applies to your company or have any concerns about payment options, do not hesitate to contact us.