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The FDA published today in the Federal Register Vol. 86, No. 3 a withdrawal of their December 29, 2020 Federal Register Notice entitled Fee Rates Under the Over-the-Counter Monograph User Fee Program for Fiscal Year 2021./p>

With the FDA’s most recent announcement, the agency is informing the public that they have been directed to cease further collection efforts related to the OTC Monograph User Fee Program until further assessment and action is announced in the Federal Register.

Please keep in mind that the CARES Act contained authorization for the FDA to assess user fees for OTC monograph manufacturing facilities and OTC monograph order requests (reviews).  We recommend continuing to plan for these fees to be implemented later during fiscal year 2021.

As further information is provided by the FDA, EAS will keep our client base informed.

Should you have any questions on this program, please contact Victoria Pankovich, Regulatory Specialist at EAS.

In the meantime, we invite you to visit our website for a number of complimentary e-learning opportunities related to OTCs.

GMPs for OTCs – Improving Compliance as FDA Eyes Enforcement Actions and “Own Label Distributor” Responsibilities. You may learn more about our comprehensive suite of services through our Pharma industry services sheet.

Posted in Client Update.