For those of you who are required to pay the OMUFA manufacturer’s fees that were due on June 2, 2025 but failed to do so, your name may appear on the OMUFA Facility Arrears List (here). Remember, failure to pay the required fees will result in the FDA finding all of your OTC products misbranded.
To emphasize the importance of appearing on this list, the notice states:
“If a facility does not pay the annual facility fee within 20 calendar days of the due date, the Agency will place the facility on a publicly available arrears list, and all OTC monograph drug products produced at that facility (or containing an ingredient manufactured at that facility) shall be deemed misbranded under section 502(ff) of the FD&C Act. Additionally, OMORs and meeting requests related to OMORs will not be accepted from persons, or their affiliates, in arrears (see section 744M(e) of the FD&C Act). We encourage you to seek verification from your business partners that all applicable fees have been received in full by the Agency.”
Please check the list carefully to avoid an unpleasant surprise.
