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 information.
SPL Documents
SPL Guidance and Supporting Documents
- Step-by-Step Instructions for Creating Structured Product Labeling (SPL) Files for Drug Establishment Registration and Drug Listing v2.0 (PDF)
- SPL Docket 92S-0251 - Drug Establishment Registration and Drug Listing (PDF)
Structured Product Labeling Implementation Guide and Validation Procedures
Structured Product Labeling Implementation Guide with Validation Procedures v1.0 (PDF)
- SPL Standard for Content of Labeling Technical Questions and Answers (PDF)
- SPL Docket 92S-0251 - Content of Labeling-CDER (PDF)
- SPL Docket 92S-0251 - Content of Labeling - CBER (PDF)
Guidance for Industry: Indexing Structured Product Labeling (Final) (PDF)
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
Resources
Other SPL Training Documentation
SPL Terminology
Terminology for Drug Establishment Registration and Drug Listing and Content of Labeling
Terminology - downloadable XML files
- Business Entity Identifiers
- Business Operation
- Code system object identifiers (OIDs)
- Color
- Document Type including Content of Labeling Type
- Dosage form
- Equivalence Codes
- Flavor
- ISO 3166-1 Alpha-3 Country Code
- Marketing Category
- Marketing Status
- Package type
- Route of administration
- Section headings
- Shape
- SPL DEA Schedule
- Time Units: Unified Code for Units of Measure (UCUM)
- UNIIs, Preferred Substance Names, and their Identified Synonyms
- Units of measure
- Units of presentation
Terminology for Indexing
- Contributing Factor - General
- Indication Category
- Intent of Use
- Lab Test
- Limitation of Use/Issues
- Medical Condition
- Pharmacokinetic Effect
- Pharmacologic Class
- Precondition Categories
- Race
- Sex
- Type of Consequence
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.