what is structured product labeling

Structured Product Labeling (SPL) is a document markup standard approved by Health Level Seven (HL7) and adopted by the U.S. Food & Drug Administration (FDA) as a mechanism for exchanging product and facility information. It defines the content of human prescription drug labeling in an XML format. The "drug labeling" includes all text, tables, and figures for a product along with additional machine-readable information (drug listing data elements) . Drug listing data elements include information about the product (proprietary and nonproprietary names, ingredients, ingredient strengths, dosage forms, routes of administration, appearance, DEA schedule) and the packaging (package quantity and type) . The SPL standard is used to enhance access to the electronic product information provided by the companies. The FDAs product information indexing initiative started with the Guidance for Industry: Indexing Structured Product Labeling in 2008. The SPL Implementation Guide with Validation Procedures is available on the FDA website.