Any person engaged in drug manufacturing, preparing, propagating, compounding, or processing in the US or that are offered for import into the US must register their establishments with the 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 their drug listing to the FDA twice each year – in June and in December. The purpose is to notify the FDA of any changes in information.
All drugs registered with the FDA must be listed in its database and maintained through periodic renewal. Only after the labeler’s code is issued will the drug listing be added to the FDA’s database (takes approximately two business days). The 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.