FDA moves to automate drug listing system

Responding quickly to criticism that its Drug Registration & Listing System is inaccurate and incomplete, FDA has proposed a new regulation to automate the process by which drug firms register themselves and list their products. According to FDA, the proposal would make the complete listing of drug products accessible electronically and would clarify current regulations that companies must comply with to register their products with FDA. It would also change the system for assigning listing numbers for the National Drug Code of marketed drugs and require that the drug code number be displayed on product labels. "The conversion to an electronic system will make the registration and listing process more efficient and effective for industry and the agency," said Janet Woodcock, FDA deputy commissioner for operations, in announcing the regulation. FDA was criticized by the inspector general of the Department of Health & Human Services earlier this month for failing to keep the drug listing current or accurate (C&EN, Aug. 21, page 36).