FDA Announces OTC Monograph User Fee for 2023

by t_king

FDA Announces Over-the-Counter (OTC) Monograph Drug User Fee Rates for Fiscal Year 2023

Over The Counter, acronym background

The U.S. Food and Drug Administration (FDA) announced today the rates for over-the-counter (OTC) monograph drug user fees for the fiscal year 2023. The announcement was made in a Federal Register Notice (FRN) titled “Over-The-Counter Monograph Drug User Fee Rates for Fiscal Year 2023”.

The FRN contains important information about the fees for OTC monograph drug facilities and OTC Monograph Order Requests (OMORs) for the upcoming year. It includes details about the facility fee calculations, OMOR fee calculations, fee due dates, and fee payment procedures.

OTC monograph drug facility fees are due on June 1, 2023, for the fiscal year 2023. If you are a facility that produces OTC monograph drugs, it’s important to take note of these dates and make sure to submit the necessary payments to avoid any penalties.

The FDA’s Over-the-Counter Monograph Drug User Fee Program (OMUFA) webpage is a great resource for those who need more information about the program. The webpage contains all the details of the program, including the program’s latest news, the program’s background, and the user fee rates that are required.

With over 20 years of experience, Compliance Insight provides a comprehensive solution tailored specifically to OTC monograph drug user fees. We are confident our expertise will streamline the process, saving you time and money when filing your annual FDA requirements.

Contact us now to discuss how we can help with your OTC monograph drug user fee needs!