On July 21, 2025, the FDA published its updated Over-The-Counter (OTC) Monograph Drug User Fee Program (OMUFA) arrears and paid facilities lists. The updated versions can be found here for the facility arrears list and here for a download of the paid list. If your facility is still engaged in the manufacture of OTC products and has not assured payment, this could result in enforcement action by the FDA. In addition, it is advised to check the list carefully and, if any mistakes are found, you should immediately contact CDER at CDERCollections@fda.hhs.gov.
Additional information regarding the OTC user fee program and the facility fees, including information on facilities that may be exempted, can be found here.
