Recently, Reed Tech has been receiving many questions from our Pharma customers regarding the Over-The-Counter Monograph User Fee Program. As a response, we enlisted our colleague and friend, Carolina Wirth, Of Counsel, Arnall Golden Gregory LLP to discuss these questions in detail with Reed Tech Account Executive, David Wilson.
Check out the video to learn the answers to the following questions and more…
• What are the penalties for non-payment or under-payment?
• What is the FDA using to determine if an MDF or CMO OMUFA fee applies?
• Are fees paid per facility or per organization?
• Do Manufacturer Fees have to be paid every year?
OTC Monograph User Fee Act (OMUFA) authorizes the FDA to collect User Facility Fees from OTC drug manufacturers. This is similar to user fees paid by prescription drug product manufacturers and sponsors. If the OTC Monograph Drug Product does not comply or is manufactured in a facility for which fees are not paid, the product is considered misbranded. You can learn more about OMUFA in general, by reading this blog post summarizing our October 2020 webinar with Gary Saner, Reed Tech, and Carolina Wirth, Arnall Golden Gregory LLP.
If you have any additional questions, feel free to reach out to Reed Tech at [email protected] or visit the FDA website and view their FAQs.