FDA Update

No More Free Rides As

FDA Reinstates OMUFA Facility Fees as of 2025

FDA is reminding companies who registered with the agency solely to manufacture hand sanitizer during the COVID-19 public health emergency that they are subject to fiscal year (FY) 2025 OMUFA facility fees, unless they delist and deregister before 12 a.m. EST on Dec. 31, 2024, if they no longer manufacture hand sanitizer.

As explained in the January 2021 Department of Health and Human Services’ (HHS) Federal Register notice (FRN), and FDA’s subsequent Federal Register notices published on  March 26, 2021, March 16, 2022 and March 27, 2023 of FY 2021-2023 OMUFA FRNs, companies that first registered with FDA during the COVID-19 public health emergency (PHE) solely for purposes of manufacturing OTC hand sanitizer products during the PHE were not identified as facilities subject to the OMUFA facility fee, for a certain time period.  That time period, which extended beyond the end of the PHE, concludes December 30, 2024.

Additionally, FDA reminded these companies they would be liable for the OMUFA facility fee for FY 2025 if they continue to manufacture hand sanitizer products after December 30, 2024, in the FRN “Over-the-Counter Monograph Drug User Fee Program – Facility Fee Rates for Fiscal Year 2024.”

The PHE expired on May 11, 2023.  Companies that continue to manufacture hand sanitizer products as of December 31, 2024, will be identified as OTC monograph drug facilities and be subject to an OMUFA facility fee for FY 2025.

Alternatively, if a company ceases manufacturing hand sanitizer products and delists and deregisters before 12 a.m. EST on December 31, 2024, it will not be identified as an OTC monograph drug facility and will not be subject to the FY 2025 OMUFA facility fee.

Additional information, including frequently asked questions and answers, can found on FDA’s OMUFA web page.

How to delist using CDER Direct : 

• Create a copy/new version of the most recent submission
• Do not change the SetID
• Generate a new DocumentID/RootID
• Enter an appropriate effective date and version number (generally, one number higher than the previous submission)
• Change the Marketing Status from ‘Active’ to ‘Complete’
• Enter an End Marketing Date corresponding to the expiration date of the last lot manufactured.
• Submit

How to deregister using CDER Direct: 

• Open the previously submitted and accepted Establishment Registration
• Click Create New Version
• Change the document type to Establishment De-Registration or Out of Business Notification as appropriate and Submit SPL
• See step by step instructions to de-register an establishment using CDER Direct
• See step by step instructions to submit an Out of Business Notification using CDER Direct

Questions?

For more information on FDA OMUFA Facility fees for hand sanitizer please email us at: info@mdiconsultants.com and ref: FDA OMUFA Facility fees for hand sanitizer.