Back in December the FDA released a Federal Register Notice announcing the fees for OTC Drug Manufacturing facilities. Since then, the FDA has withdrawn the FRN. Originally, through the OMUFA webpage, it is stated that “[T]he Department clarifies that persons that were not registered with FDA as drug manufacturers prior to the COVID-19 Public Health Emergency, which then later registered with FDA for the purpose of producing hand sanitizers, are not “identified” as “OTC drug manufacturing facilit[ies]” under section 744M of the FD&C Act, 21 U.S.C. 379j-72, and are thus not subject to the facility fee contained therein. [Docket no. FDA–2020–N–2246].”
After inquiry with the FDA, they have confirmed that “pursuant to the withdrawal of the fee-setting FRN titled “Fee Rates Under the Over-the-Counter Monograph Drug User Fee Program for Fiscal Year 2021”, all OMUFA fees are currently not in effect and the FDA has not assessed user fees for OMUFA at this time.”
The FDA intends to continue implementation of the OTC monograph drug user fee program in an appropriate and transparent manner, including with respect to facility fees, and in accordance with the Department of Health and Human Service’s notice. Any additional updates will be provided through the OMUFA webpage.
If you have any additional questions or need assistance with FDA regulation and compliance, please email mdi Consultants at firstname.lastname@example.org RE: OTC Drug Fees.