Live Breaking News & Updates on Otc Monograph Drugs

Thursday, April 1, 2021
On March 26, 2021, the FDA updated and reissued the fee rates for the newly created over-the-counter (OTC) monograph Drug User Fee program (OMFUA) for FY2021 in a Federal Register Notice (FRN) titled “
Fee Rates under the Over-The-Counter Monograph Drug User Fee Program for Fiscal Year 2021.” The CARES Act, passed by Congress on March 27, 2020, established OMUFA, FDA’s newest user fee program, which granted FDA the ability to assess and collect two types of fees: OTC monograph drug facility (MDF) fees and OTC Monograph Order Request (OMOR) fees. 
The initial notice issued by FDA on December 29, 2020, was quickly withdrawn by the HSS amid controversy surrounding FDA’s plan to collect user fees from manufacturers, including liquor distilleries, that stepped up to meet the US (and world) demand for increased production of hand sanitizers under the Agency’s temporary enforcement policy during the COVID-19 pandemic.  ....

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