Regulatory News

US OTC Monograph Drug Facility Fees Notice Withdrawn

Jan. 13 2021

The U.S. Health and Human Services (HHS) Department has withdrawn the Food and Drug Administration (FDA) notice announcing the U.S. Over-the-Counter Monograph Drug User Fee Program (OMUFA) facility fee rates because the HHS Secretary did not approve the document. As such, the FDA was ordered to stop collecting user fees until the Secretary has approved “further direction concerning FDA’s administration of OMUFA.”  

The HHS sent an additional notice clarifying that companies that entered the Over-the-Counter (OTC) “drug industry for the first time in order to supply hand sanitizers during the COVID-19 Public Health Emergency are not persons subject to the facility fee.” The notice further explains the basis for exempting these facilities. 

Click to view the withdrawal Federal Register notice.  

Click to view the HHS clarification notice.

Click to view the original Federal Register notice.

Click to view the FDA Over-the-Counter Monograph User Fee Program (OMUFA) website.

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