ANNUAL CERTIFICATION AND RENEWAL ESTABLISHMENT REGISTRATION

The establishment registration needs to be renewed every year and needs to submit a “no change” certification if there is no change in drug listing.

Obligation to renew the registration during the open period October to December. The product of an establishment not renewed by December 31 will be deemed as misbranded and subject to regulatory action. For the listing, it will be needed to submit a no change certification every year during the renewal period. As per the 2016 new rule, any product listing that is not certified as required may be considered inactive and will be removed from the NDC directory and other publications of listing data.