All FDFs or APIs manufactured in a facility for which fees have not been paid or self identifying
information had not been submitted and all FDFs containing APIs
manufactured in such a facility will be deemed misbranded. This means that it will be a
violation of federal law to ship these products in interstate commerce or to import them
into the United States. Such violations can result in prosecution of those responsible,
injunctions, or seizures of misbranded products. Products misbranded because of failure
to pay facility fees or self-identify are subject to being denied entry into the United
States.
Additionally, there are several consequences for failure to pay a facility fee:
(1) no new generic drug submission referencing the facility will be received
until the fee is paid.
(2) the facility will be placed on a publicly available arrears list if the fee is not
fully paid within 20 days of the due date.
(3) FDA will notify the ANDA applicant of the facility’s failure to satisfy its
user fee obligations.
Goal dates also may not apply to applications that have already been received but list
facilities for which facility fees are owed.
