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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 and facility information.

 

SPL Guidance Documents

Guidance to industry: Providing Regulatory Submissions in Electronic Format - Content of Labeling (Final) (PDF)
Guidance for Industry: Providing Regulatory Submissions in Electronic Format – Drug Establishment Registration and Drug Listing (Final)(PDF)
Guidance for Industry: SPL Standard for Content of Labeling Technical Questions and Answers (PDF)
Guidance for Industry: Indexing Structured Product Labeling (Final) (PDF)
Guidance for Industry: Self-Identification of Generic Drug Facilities, Sites, and Organizations (DRAFT) (PDF)
Guidance for Industry:  Electronic Submission of Lot Distribution Reports (DRAFT) (PDF)

 

SPL Implementation Guide and Validation Procedures

Structured Product Labeling Implementation Guide with Validation Procedures v1.0 (PDF))
Step-by-Step Instructions for Creating Structured Product Labeling (SPL) Files for Drug Establishment Registration and Drug Listing v2.0 (PDF)

 

GDUFA SPL Step-by-Step Instructions & Technical Specifications

GDUFA Self ID SPL Industry Technical Specification Information (PDF)
GDUFA SPL Step-by-Step Instructions for Self-Identification of Facilities, Sites, and Organizations (PDF)

 

SPL Dockets

SPL Docket 92S-0251 - Drug Establishment Registration and Drug Listing (PDF)
SPL Docket 92S-0251 - Content of Labeling-CDER (PDF))
SPL Docket 92S-0251 - Content of Labeling - CBER (PDF)

 

SPL Schema and Stylesheet

FDA SPL Schema for Implementation (zip file last updated October 1, 2012)
FDA SPL stylesheet (zip file last updated December 4, 2013) - send comments to spl@fda.hhs.gov 

 

Download Labels

FDA Online Label Repository

 

Resources

Comprehensive NDC SPL Data Elements File (NSDE)
Indexing SPL Fact Sheet
SPL Standard Training
SPL Xforms
SPL Training Material
FDA Electronic Secure Gateway
SPL Software and Conversion Vendors disclaimer icon
 

 

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.

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