Structured Product Labeling

Structured Product Labeling (SPL) is a Health Level Seven International (HL7) standard that defines human prescription drug labeling in XML format. It includes all published material accompanying a drug, such as Prescribing Information, which contains detailed data about the drug. As of Release 4, over 22,000 FDA product inserts have been encoded using the SPL standard.

SPL documents contain both the content of labeling (text, tables, and figures) and machine-readable information (drug listing data elements). These data elements include details about the product, such as proprietary and nonproprietary names, ingredients, strengths, dosage forms, routes of administration, DEA schedule, and packaging specifics like quantity and type.

Since October 31, 2005, FDA labeling submissions to the Center for Drug Evaluation and Research (CDER) must be in SPL format. Annual reports also require SPL-compliant content. The FDA introduced a new Prescribing Information (PI) format in January 2006, requiring three sections: Highlights of Prescribing Information, Table of Contents, and Full Prescribing Information (FPI). Starting June 1, 2009, all companies producing pharmaceuticals, OTC products, biologics, veterinary medicines, and distributors must submit labeling in SPL format.

FDA-approved SPLs are available on the National Library of Medicine’s DailyMed website for public access. In 2008, the FDA released guidance for indexing SPL to enhance usability and efficiency. The SPL Working Group, formed by PhRMA and HL7 in January 2004, includes industry representatives, FDA officials, vendors, and HL7 members. It aims to raise awareness, provide resources, discuss issues, and guide future developments of the SPL standard.