Facilities who have not complied with paying the annual OTC Monograph User Fee Program (OMUFA) fees required under section 744M of the FD&C Act, are now publicly listed on the FDA arrears list. FDA has also stated that they “will periodically update the arrears list to reflect facility payments.”

If you believe that you were improperly listed, or believe you meet exemption requirements, reach out to Bustos Law Group for assistance.

To download and view the list, please click the link below (head to User fee section):

https://www.fda.gov/industry/fda-user-fee-programs/over-counter-monograph-user-fee-program-omufa