FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA

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

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

Guidance for Industry: Indexing Structured Product Labeling (Draft)

SPL Release 3 Implementation Guide for FDA Drug and Biological Products v1.1 (updated January 16, 2007) PDF

SPL Implementation Guide Archive (zip file of older versions of the SPL implementation guides)

FDA SPL Schema for Implementation (zip file last updated 05/21/07)

FDA SPL stylesheet (last updated 10/15/07) - send comments to spl@fda.hhs.gov

Stylesheet Archive (zip file of older versions of the FDA SPL stylesheets)

Electronic Labeling Information Processing System (ELIPS) Validation and Conformance Rules PDF

SPL Standard for Content of Labeling Technical Questions and Answers HTML

SPL Docket 92S-0251 - Content of Labeling

SPL Highlights data element table PDF Zip file

SPL Update - July 2006

SPL Data Element Examples

SPL release 4 evaluation material for registration and listing Version 0.3

Download Labels

FACTS@FDA

Resources

Announcement for HL7 SPL WG Electronic Establishment Registration Hands-On Training Session-April 9, 2008

Announcement for HL7 SPL WG Electronic Establishment Registration and Drug Listing Follow-up Session - April 2, 2008

SPL Vendor Training - Follow-up Session - April 2, 2008

HL7 SPL Working Group Electronic Establishment Registration and Drug Listing Meetings - February 2008

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

SPL Release 4 Discussion at the HL7 Working Group Meeting - January 15 and 16, 2008

SPL Vendor Training - February 1, 2008

SPL for PLR - April 27th SPL Workshop Presentation - Randy Levin, FDA

Introduction to SPL Changes with the Physician Labeling Rule

Highlights Text and Data Elements in Structured Product Labeling

Codes System and Controlled Vocabulary in SPL Presentation - Randy Levin, FDA

SPL at the FDA: A Progress Report - Lisa Stockbridge, FDA

Presentations from Structured Products Labeling - Benefits and Challenges Meeting (6/4/04)

HL7 RCRIM

SAX Parser

SPL Terminology

• Route of administration
• Dosage form
• Package type
• Potency (units of measure and units of presentation)
• Color
• Shape
• Coating
• Size
• Scoring
• Imprint codes
• Symbols
• SPL DEA Schedule
• Section headings
• Code system object identifiers (OIDs)
• 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
• Document Type including Content of Labeling Type
• Limitation of Use/Issues
• Time Units: Unified Code for Units of Measure (UCUM)
• Indication Category
• Substances/Unique Ingredient Identifiers (UNIIs)
• Business Operation
• Marketing Category
• Marketing Status
• Equivalence Codes
• Flavor

Contact Information

Questions regarding SPL submissions should be directed to:

• Abbreviated New Drug Applications: Koung Lee - 301-827-7336
• New Drug Applications: Lonnie Smith - 301-594-0011
• Anyone having difficulty with the Highlights data elements in SPL in their submission should contact us at spl@fda.hhs.gov for individual assistance.

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 Lori A Baranoski (Lori.Baranoski@bms.com) or see http://spl.intrasphere.com.

For help accessing PDF, Word, Excel, and Zipped files, go to General Help for Accessing Files on this Web site.

FDA Data Standards Council Home Page

FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | Privacy | Accessibility

FDA Website Management Staff