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  1. FDA Resources for Data Standards

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


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.

Resources For You

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