The FDA is proposing a system whereby drug information is electronically submitted and accessed, building a searchable database. Currently, part of the list is kept on paper.
Users of the list include other government agencies, healthcare providers and healthcare payers.
The list, which currently has more than 120,000 drug products, contains up-to-date information about specific drug formulations and manufacturers. The data includes ingredients, dosage forms, strengths, labeling and manufacturer information.
Drug developers and manufacturers would be required to submit establishment registration and drug listing information electronically.
This will help us maintain more accurate information and make it easier for us to respond to drug emergencies such as recalls and drug shortages, said HHS secretary Mike Leavitt.
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. By providing FDA better-organized and more reliable information about drugs in the marketplace, this initiative also supports the agency’s continuing efforts to ensure the safety and quality of drugs in the United States.
