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U.S. Department of Health and Human Services

For Industry

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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 information.

 

SPL Documents

 

SPL Guidance and Supporting Documents

Guidance for Industry: Providing Regulatory Submissions in Electronic Format – Drug Establishment Registration and Drug Listing (Final)(PDF)

 

Structured Product Labeling Implementation Guide and Validation Procedures

Structured Product Labeling Implementation Guide with Validation Procedures v1.0 (PDF)

 

Guidance to industry: Providing Regulatory Submissions in Electronic Format - Content of Labeling (Final) (PDF)

 

 

Guidance for Industry: Indexing Structured Product Labeling (Final) (PDF)

 

Indexing Structured Product Labeling for Human Prescription Drug and Biological Products; Request for Comments FR Notice

 

SPL Schema and Stylesheet

FDA SPL Schema for Implementation (zip file last updated February 17, 2012)

FDA SPL stylesheet (zip file last updated February 13, 2012) - send comments to spl@fda.hhs.gov 

Download Labels

FDA Online Label Repository

 

Resources

SPL Standard Training

SPL Xforms

SPL Training Material

Other SPL Training DocumentationExit Disclaimer 

FDA Electronic Secure Gateway

HL7 RCRIM

 

 

SPL Terminology

 

Terminology for Drug Establishment Registration and Drug Listing and Content of Labeling

 

Terminology - downloadable XML files

 

 

Terminology for Indexing

 

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.

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