Structured Product Labeling

Structured Product Labeling (SPL) defines the content of human prescription drug labeling in an XML format. This format is defined within the SPL schema and is displayed in a web browser using the SPL stylesheet. It is approved by Health Level Seven (HL7) and has been adopted by FDA as a mechanism for exchanging medication information. Since October 31, 2005, labeling submissions to the FDA's Center for Drug Evaluation and Research (CDER) must be in SPL format. In addition, annual report submissions must contain content of labeling in SPL format.

SPL documents contain both the content of labeling (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 (product and generic names, ingredients, ingredient strengths, dosage forms, routes of administration, appearance, DEA schedule) and the packaging (package quantity and type).

In January 2006, the FDA unveiled a major change to the format of prescription drug information, commonly referred to as the Physician Labeling Rule (PLR). The new format requires that the content of labeling be organized in a specific manner. Other changes include the addition of a Highlights section that contains key benefit and risk information, a table of contents, the date of initial product approval, and a toll-free number and URL for reporting suspected adverse events.

FDA-approved SPLs can be viewed and downloaded from "DailyMed" on the National Library of Medicine web site. DailyMed provides free access to consumers and health information providers to comprehensive, up-to-date labeling as found in medication package inserts.

A number of products exist to facilitate SPL creation. As well, many vendors provide consultation and conversion services to move content into the SPL XML format.