This morning, the FDA published a reminder (here) that over-the-counter (OTC) monograph user fees (OMUFA) for facilities must be paid today, noting that it “is in reference to the March 29, 2024, Food and Drug Administration Federal Register notice (FRN) titled ‘Over-the-Counter Monograph Drug User Fee Program-Facility Fee Rates for Fiscal Year 2024.’ The fiscal year (FY) 2024 Over-the-Counter (OTC) monograph drug facility fees are due today, June 3, 2024. If you are a qualifying owner of an OTC monograph drug facility, as described in sections 744M and 744L of the Federal Food, Drug, and Cosmetic Act, please visit FDA’s payment portal and submit your payment.”
We explained the consequences for failure to pay the facility fee in a timely manner in a 2021 blog post (here), and noted that over 500 firms were placed on the original OTC arrears list for failing to pony up before the first deadline, meaning that any OTC product manufactured at their facilities would be considered misbranded. Remember, this fee is associated with OTC drugs being manufactured under an OTC monograph but not for OTC drugs being marketed under an approved NDA or ANDA as PDUFA or GDUFA fees, respectively, apply to OTCs marketed under an approved application.
You don’t have time to take out your checkbook, but fees can be paid through the FDA portal (here) today to be in compliance with the due date.
