Any person engaged in drug manufacturing, preparing, propagating, compounding or processing in US or that are offered for import into US must register their establishments with Food and Drug Administration (FDA) as well as list each drug manufactured at their establishment for commercial distribution. They must also submit updated information about drug listing to FDA twice each year – June and December. The purpose is to notify FDA if there is any change in information.
All drugs registered with FDA must be listed in its database and maintained through period renewal. Only after the labeller’s code is issued, the drug listing will be added to the FDA’s database in around two business days. FDA NDC database will confirm the drug listing and its status will be indicated. Drug listings have to be updated annually to ensure their status is active.