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Reminder: FDA is Now Beginning To Collect OTC Monograph User Fees

Updated: Oct 24


As we reported in our previous blog post, the FDA is now collecting OTC Monograph User Fees beginning May 10, 2021. These fees will apply to contract manufacturers and private labelers, but exemptions apply for hand sanitizer manufacturers who started manufacturing during the COVID-19 pandemic. Read more here:

OTC Monograph User Fees

Please reach out if you have questions about these fees and how they will affect your business. Contact info@bustoslawgroup.com or call (832) 592-7851.



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