For certain “companies that first registered with the 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 31, 2024.”

If your facility has discontinued the manufacture of OTC hand sanitizer products, you have until December 31, 2024 to de-list and/or de-register your product and facility as the FDA reminds firms that “these companies will be liable for the OMUFA facility fee for FY 2025 if they continue to manufacture hand sanitizer products after December 30, 2024, as described in the FRN Over-the-Counter Monograph Drug User Fee Program – Facility Fee Rates for Fiscal Year 2024.” If you fail to take action as identified below, you will be liable for the 2025 fee payment.

If “a company ceases manufacturing hand sanitizer products and de-lists and de-registers 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.”

The Notice indicates the steps needed to de-list the product and de-register your facility as follows:

 

“How to de-list 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 de-register 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

Contact edrls@fda.hhs.gov with questions about how to update a registration or de-register an establishment.”

 

This obviously does not apply to firms that also manufacture other OTC products at the same facility.