FDA Warns Drug Makers: Update Drug Listings Or Come Off Market

FDA warned domestic and foreign drug makers that beginning Sept. 12 it will inactivate drug listings in the National Drug Code (NDC) directory that haven’t been recently updated or certified or that include an establishment with an expired registration. In a Federal Register notice Tuesday (Aug. 13), the agency says that tens of thousands of records in the NDC directory, the NDC Structured Product Labeling Data Elements (NSDE) file and other public drug listing databases could be affected, and it...