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

 
• By Malcolm Spicer

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.

• Source: Shutterstock

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.

The FDA on 16 July announced it is reminding companies which registered with the agency solely to manufacture hand sanitizers during the COVID-19 public health emergency that they will be subject to fiscal year 2025 OTC monograph user fees if they

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