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FDA announced the fiscal year 2024 OTC-Monograph Drug User Fee rates in the Federal Register Vol 89, No. 62 published 29 March 2024. These fees cover FDA’s FY2024 which runs from October 2023 through September 2024. The facility fees for FY 2024 are due on 3 June 2024.

Regarding fee specifics,

  • Owners of manufacturing and processing facilities of finished OTC-drug dosage forms will pay a full facility fee: $34,166
  • Owners of a contract manufacturing facility will pay 2/3 of the full fee: $22,777
  • Submitters of OTC monograph order requests (OMOR) will pay tier-based user fees, (with the exception of those submitting certain safety-related changes). Tier 1 OMOR user fees are assessed at $537,471, Tier 2 OMOR user fees are assessed at $107,494

The facility fees are assessed on any facility that identified the business process of OTC monograph drug facility in their establishment registration during the fee-liable period of 1 January 2023 through 31 December 2023.

Again, the fees are due on 3 June 2024. Payments must be made in U.S. currency by electronic check or wire transfer, with FDA’s preference being an online payment via e-check. If using a wire transfer, remember to include the PIN assigned to your cover sheet, and do factor in any bank fees to ensure the full amount reaches the FDA.

Posted in Drugs, FDA and USDA Regulatory Update.