As of last year, FDA requires that drug establishments “certify” listings that have not been changed since the previous calendar year during the annual registration renewal period. In an email to industry this week, FDA stated that manufacturers and repackagers that have not yet incorporated the new product identifier requirements into their labels should not certify that their drug listings are up-to-date during the upcoming registration renewal period (October 1, 2018 to December 31, 2018). Industry should submit a new sampling of the labeling incorporating the product identifier as an update to their listing.
