Structured Product Labeling

Structured Product Labeling (SPL) is a Health Level Seven International (HL7) standard which defines the content of human prescription drug labeling in an XML format. The "drug label" includes all published material accompanying a drug, such as the actual label on a prescribed dose as well as the package insert which contains a great deal of detailed information about the drug. As of Release 4 of the SPL standard, 22,000 FDA informational product inserts have been encoded according to the standard.

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).

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.

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.

Starting June 1, 2009, the FDA will require all OTC companies and Veterinary Medicines (Vet Med) manufacturers to submit their product labeling in compliance with the SPL standards. Additionally, all companies that produce Pharmaceutical (Rx), Over-the-Counter (OTC), Biologics products, Veterinary medicines, and distributors must provide FDA with all registration listing and drug listings in the SPL electronic format.

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.

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