FDA plans system for standardized drug labeling

The General Services Administration has issued a request for information on behalf of the Food and Drug Administration about hardware and software for developing systems to process electronically drug label information.

Through the Structured Product Labeling Project, FDA wants to create a standard labeling system that will allow the exchange of information on all drug products marketed in the United States.

GSA's Federal Systems Integration and Management Center released http://www.fts.gsa.gov/fdaspl/docs/FDA_SPL_RFI.pdf the RFI.

The structured product labels would contain information such as how and when to use a product, dose recommendations and possible adverse effects. The goal is to improve patient safety by ensuring that the most up-to-date medication information is available to health care providers, patients and the public.

The project is part of the larger DailyMed Initiative, a partnership of FDA, the National Library of Medicine, medication manufacturers and distributors, and health care information suppliers.

The effort will require changes to regulations, development of standards, creating new IT systems, training, and changes in data entry and quality control of drug listings.

Responses to the RFI are due by Nov. 3. FDA wants to begin developing the system in February.