No. Most facilities that are required to self-identify are also required to pay an
annual facility user fee, but certain types of generic facilities, sites and
organizations are not. These include facilities, sites and organizations that solely
manufacture PET drugs; clinical bioequivalence or bioavailability study sites; in
vitro bioequivalence testing or bioanalytical testing sites; API/FDF analytical
testing sites; and repackagers. Please note that while repackagers are not required
to pay user fees, packagers are, in most cases, FDF manufacturers and subject to
facility fees.
