Structured Product Labeling


Structured Product Labeling is a Health Level Seven International standard which defines the content of human prescription drug labeling in an XML format. The "drug labeling" includes all published material accompanying a drug, such as the Prescribing Information 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 for a product along with additional machine readable information. Drug listing data elements include information about the product and the packaging.

Background

Since October 31, 2005, labeling submissions to the FDA's Center for Drug Evaluation and Research 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 the Prescribing Information, commonly referred to as the Physician Labeling Rule format. The new format requires three sections. The Highlights of Prescribing Information section contains selected information from the FPI that health care practitioners most commonly reference and consider most important. The Highlights of Prescribing Information includes a toll-free number and URL for reporting suspected adverse events and a Revision Date that identifies the month and year of the last change to the PI. The Table of Contents lists the sections and subsections of the Full Prescribing Information. The FPI contains the detailed prescribing information necessary for safe and effective use of the drug including indications, limitations of use, recommended dosage, contraindications, warnings and precautions, adverse reactions, clinically significant drug interactions, information about use in specific populations, drug abuse and dependence, overdosage, and other information about the prescription drug.
Starting June 1, 2009, the FDA required all OTC companies and Veterinary Medicines manufacturers to submit their product labeling in compliance with the SPL standards. Additionally, all companies that produce Pharmaceutical, Over-the-Counter, 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 Prescribing Information.

SPL Working Group

The SPL Standard was initially developed by a small group within the HL7 Regulated Clinical Research Information Management Technical Committee. HL7 is an independent and international provider of healthcare standards. PhRMA HL7 Task Group formed the SPL Working Group in January 2004 to further the work of the initial development team.

Composition of the SPL Working Group

The SPL Working Group has a Technical Team and a Process Communications Forum. Additionally, a variety of subteams address specific topical and subject issues. Current subteams include: Biologics, VetMeds, Devices, Generics, Establishment Registration Lifecycle, Labeling Content Lifecycle, and Over-the-Counter Products. These teams meet regularly, and meeting information and minutes of past meetings are available on the SPL Working Group All Sub-Groups wiki page.

Current Objectives of the SPL Working Group

SPL specification outline

Format

Examples

Use of LOINC, UNII, SNOMED-CT, UCUM, and other controlled terminologies

Sections

TBD. General outline of the document tree

title

Class
Other details

title of component

Etc

Misc

SPL Solutions

Various approaches exist for creating and managing content and data in SPL format. Solutions fall under three basic categories.