Failure To Maintain Listings May Affect Operations and Coverage for Reimbursement –

The Federal Food, Drug, and Cosmetic Act (“FDCA”) has long required pharmaceutical manufacturers, repackers, relabelers, and salvagers to register their production facilities, and to list each drug product currently manufactured there for commercial distribution. In the past, registrants were required to revise drug listings, as needed, at least twice per year (e.g., to note discontinued products, or to update previously submitted information). Revised Food and Drug Administration (“FDA”) regulations added a new requirement, effective for 2017, that registrants not only update changed information in drug product listings on a periodic basis, but also that they certify annually (when applicable) that unchanged, previously submitted listing information has been reviewed and remains up-to-date (i.e., no changes required). The purpose is to enhance the overall accuracy of the FDA database. FDA intends to purge information that was not updated or certified “no changes” during 2017 from the NDC Directory and other drug listing publications in 2018.