Federal Register Notice: FDA is making available a guidance for industry, Indexing Structured Product Labeling. CBER and CDER will index structured product labeling (SPL) in the product labeling for human drug and biologic products. SPL enables the electronic exchange of the content of labeling and other regulated product information using the extensible markup language. The SPL standard enables the inclusion of indexing elements with product labeling. These machine-readable identifiers enable users with clinical decision support tools and electronic prescribing systems to rapidly search and sort product information found in product labeling. Indexing the content of labeling with SPL will greatly facilitate the efficient communication of important drug information to the public, helping create a more robust nationwide system for promoting the safe and effective use of drugs.

The document also makes recommendations to industry on how to submit input on the indexing information in the SPL. To download this guidance, click here. To view this notice, click here.