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 medication information.

SPL Documents

SPL Guidance and Supporting Documents

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

• Structured Product Labeling Implementation Guide for FDA Drug Establishment Registration and Drug Listing v1.0 (updated July 10, 2008) PDF
• Structured Product Labeling Validation Procedures for Drug Establishment Registration and Drug Listing v1.0 PDF
• Instructions for using Electronic Drug Establishment Registration and Drug Listing XForms v1.0 PDF
• SPL Docket 92S-0251 - Drug Establishment Registration and Drug Listing

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 Release 3 Implementation Guide for FDA Drug and Biological Products v1.1 (updated January 16, 2007) PDF
• Electronic Labeling Information Processing System (ELIPS) Validation and Conformance Rules PDF
• SPL Docket 92S-0251 - Content of Labeling-CDER
• SPL Docket 92S-0251 - Content of Labeling - CBER
• 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

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

HL7 RCRIM

SAX Parser

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 April 16, 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.

• Route of administration
• Dosage form
• Package type
• Units of measure and units of presentation
• Color
• Shape
• SPL DEA Schedule
• Section headings
• Code system object identifiers (OIDs)
• Document Type including Content of Labeling Type
• Time Units: Unified Code for Units of Measure (UCUM)
• UNIIs, Preferred Substance Names, and their Identified Synonyms
• Business Operation
• Marketing Category
• Marketing Status
• Equivalence Codes
• Flavor
• ISO 3166-1 Alpha-3 Country Code
• Business Entity Identifiers

Terminology for Indexing

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

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).

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