For Industry

Structured Product Labeling Resources

The Structured Product Labeling (SPL) is a document markup standard approved by Health Level Seven (HL7) and adopted by FDA as a mechanism for exchanging product and facility information.

SPL Guidance Documents

SPL Implementation Guide and Validation Procedures

GDUFA SPL Step-by-Step Instructions & Technical Specifications
SPL Dockets

SPL Schema and Stylesheet

Download Labels

Resources

SPL Terminology

SPL Terminology Files for Validation
Terminology for Indexing SPL

Contact Information

Questions regarding SPL submissions should be directed to: spl@fda.hhs.gov.

SPL Implementation Workgroup: The SPL Implementation Workgroup is composed of SPL vendors and members from the pharmaceutical industry, academia, HL7, FDA, and SPL developers who meet regularly to discuss issues regarding the SPL implementation in general and the SPL implementation guide. Membership in HL7 is not required to participate. For more information regarding the Workgroup, contact Terry Brunone (Terry Brunone). See "Resources for You" section on this web page for the SPL Working Group web page.

The National Council for Prescription Drug Programs (NCPDP) WORK GROUP 2 PRODUCT IDENTIFICATION: The SPL Activities Task Group is composed of Manufacturers, Payers/Processors, Drug Compendia, and the FDA who meet to discuss issues/enhancements regarding the SPL. Membership in NCPDP is not required to participate. For more information regarding the SPL Activities Task Group, contact Patsy McElroy. See "Resources for You" section on this web page for the SPL Activities Task Group web page.

Page Last Updated: 12/15/2014
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