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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 medication information.
Guidance for Industry: Indexing Structured Product Labeling (Final)
FDA SPL Schema for Implementation (zip file last updated July 10, 2008)
FDA SPL stylesheet (last updated October 15, 2008) - send comments to spl@fda.hhs.gov
Stylesheet Archive (zip file of older versions of the FDA SPL stylesheets)
SPL R4 Vendor Training Web Conference Wednesday, February 4, 2009
FDA Amendments Act of 2007 - Section 224 - Electronic Registration and Listing
Drug Registration and Drug Listing and Content of Labeling Terminology Lists in XML format - Downloadable file (zip file updated January 18, 2009)
Additional Validation Files - Downloadable file (zip file updated August 15, 2008) See "Structured Product Labeling Validation Procedures for Drug Establishment Registration and Drug Listing" for information on the use of the additional validation files.
Questions regarding SPL submissions should be directed to: spl@fda.hhs.gov.
HL7 SPL Implementation Workgroup: The HL7 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).
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