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

Executive Summary

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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