The Food and Drug Administration could not have known, when it gained authority for OTC monograph facility fees, the lengths it would need to go to explain whether businesses are subject to the fees after unplanned and short-lived OTC production during the COVID-19 pandemic.
FDA Delivers OTC Monograph Facility Fees For Fiscal 2024 With Highlights On Some RSVPs
FDA “is highlighting” in its FY2024 facility fees announcement, and using italics for “emphasis added” for some statements, that businesses previously but no longer making hand sanitizers, though still selling the products, should contact the agency to assure they’re not assessed fees.