Pandemic Emergency OTC Sanitizer Makers Have 22 Weeks To Avoid Paying Monograph User Fees

FDA reminds companies which registered with agency solely to manufacture OTC sanitizers during COVID-19 public health emergency they will be subject to FY2025 OTC monograph user fees if they don’t delist and deregister as monograph drug manufacturers by 12 a.m. on 31 December.

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The clock is ticking, or more precisely, calendar pages are turning for businesses that made OTC hand sanitizers available in the US during the COVID-19 pandemic to notify the Food and Drug Administration if they no longer provide the products.

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