US FDA halts implementation of Over-The-Counter Monograph User Fee Program (OMUFA) for 2021

On December 29, the U.S. Food and Drug Administration (FDA) announced the 2021 rates for over-the-counter (OTC) monograph drug user fees. However, on January 6 2021 the FDA formally withdrew the notice citing that it lacked delegated authority.

The previous notice detailed the assessment and collection of user fees from qualifying manufacturers of OTC monograph drugs and submitters of OTC monograph order requests (OMOR). FDA was given authority to begin collecting these fees under the Coronavirus Aid, Relief, and Economic Security (CARES) Act of March 2020. Once OMUFA is fully implemented, fees may be specifically assessed and collected from Monograph Drug Facilities (MDF) and Contract Manufacturing Organizations (CMOs). FDA may also plan to assess and collect fees from submitters of OMORs, except for OMORs which request certain safety-related changes outlined in the register notice.

More information regarding Over-The-Counter Monograph User Fee Program (OMUFA) implementation will be forthcoming.

How TSG can help

TSG is currently monitoring the implementation of these new regulations. When implemented, TSG’s consultants can assist with assessing your facility’s fees for subsequent fiscal years and facilitate submission of your payment through the appropriate channels. For more information contact us at [email protected]