On March 26, 2021, the US Food and Drug Administration (FDA) announced its 2021 fees for OTC monograph drug facilities under the Over-the-Counter Monograph Drug User Fee Program (OMUFA). This fee assessment was authorized by the Coronavirus Aid, Relief, and Economic Security (CARES) Act which added a new provision to the Federal Food, Drug and Cosmetic Act. Hand sanitizer producers who registered with FDA solely to produce hand sanitizer during the COVID-19 public health emergency will remain exempt from paying the facility fees.
*Screenshot from FDA Website
OMUFA Facility fees are due on May 10th. FDA will not send an invoice prior to the due date for these fees. To received an invoice and pay your OMUFA fees online, follow the instruction sheet provided by FDA at https://userfees.fda.gov/OA_HTML/omufaCAcdLogin.jsp.
FDA has also issued a warning to OTC Monograph facilities that a third-party organization who is not affiliated with the FDA is sending invoices to firms to process the payment on your behalf. These invoices are not from the FDA and do not represent the OMUFA facility fee. There are no additional administrative or processing fees to make the payment online.
FDA encourages any firm to contact them at CDERCollections@fda.hhs.gov or 301-796-7900 for assistance in processing the fee payment.