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Warning letters, 483s, Recalls, Import Alerts, Audit observations
Warning letters, 483s, Recalls, Import Alerts, Audit observations
FDA has announced the over-the-counter (OTC) monograph drug facility (MDF) fee rates under the OTC monograph drug user fee program (OMUFA) for fiscal year (FY) 2024.
These facility fees are effective on October 1, 2023, and will remain in effect through September 30, 2024.
The fee are due by June 3, 2024
The OTCMDF is a facility that is engaged in manufacturing or processing finished dosage form of an OTC monograph drug. A CMO facility is an OTC monograph drug facility where neither the owner nor any affiliate sell the OTC monograph drugs manufactured by it directly to wholesalers, retailers of consumers in US.
The OTCMDF facility fee is not applicable to entities registered with FDA on or after January 27, 2020 whose sole activity consists of manufacturing OTC hand sanitiser products during pandemic. The OTCMDF fee is also not applicable to facilities that manufacture an Active Pharmaceutical ingredient (API) for an OTC monograph drug product.
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