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)

• Structured Product Labeling Implementation Guide for FDA Drug Establishment Registration and Drug Listing v2.0 PDF
• Structured Product Labeling Validation Procedures for Drug Establishment Registration and Drug Listing v2.0 PDF
• 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

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

• SPL Standard for Content of Labeling Technical Questions and Answers HTML
• SPL Docket 92S-0251 - Content of Labeling-CDER PDF
• SPL Docket 92S-0251 - Content of Labeling - CBER PDF
• SPL Implementation Guide Archive (zip file of older versions of the SPL implementation guides)

Guidance for Industry: Indexing Structured Product Labeling (Final)

SPL Schema and Stylesheet

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)

Download Labels

FACTS@FDA

Resources

SPL Release Four Sessions:  Preparing Drug Establishment Registration and Drug Listing Submissions - February 2009 - October 2009

FDA Amendments Act of 2007 - Section 224 - Electronic Registration and Listing

FDA Electronic Secure Gateway

HL7 RCRIM

SPL Terminology

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

Drug Registration and Drug Listing and Content of Labeling Terminology Lists in XML format - Downloadable file (zip file updated June 24, 2009)
Additional Validation Files - Downloadable file (zip file updated June 21, 2009) See "Structured Product Labeling Validation Procedures for Drug Establishment Registration and Drug Listing" for information on the use of the additional validation 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 and units of presentation

Terminology for Indexing

• Contributing Factor - General
• Indication Category
• Intent of Use
• Lab Test
• Limitation of Use/Issues
• Medical Condition
• Pharmacokinetic Effect
• Pharmacological Class - Mechanism of Action
• Pharmacological Class - Physiologic Effect
• Pharmacological Class - Structural Class
• Precondition Categories
• Race
• Sex
• Type of Consequence

Contact Information

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).