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 and facility information.
SPL Guidance Documents
Guidance to industry: Providing Regulatory Submissions in Electronic Format - Content of Labeling (Final) (PDF)
Guidance for Industry: Providing Regulatory Submissions in Electronic Format – Drug Establishment Registration and Drug Listing (Final)(PDF)
Guidance for Industry: SPL Standard for Content of Labeling Technical Questions and Answers (PDF)
Guidance for Industry: Indexing Structured Product Labeling (Final) (PDF)
Guidance for Industry: Self-Identification of Generic Drug Facilities, Sites, and Organizations (DRAFT) (PDF)
SPL Implementation Guide and Validation Procedures
Structured Product Labeling Implementation Guide with Validation Procedures v1.0 (PDF))
Step-by-Step Instructions for Creating Structured Product Labeling (SPL) Files for Drug Establishment Registration and Drug Listing v2.0 (PDF)
GDUFA SPL Step-by-Step Instructions & Technical Specifications
GDUFA Self ID SPL Industry Technical Specification Information (PDF)
GDUFA SPL Step-by-Step Instructions for Self-Identification of Facilities, Sites, and Organizations (PDF)
SPL Dockets
SPL Docket 92S-0251 - Drug Establishment Registration and Drug Listing (PDF)
SPL Docket 92S-0251 - Content of Labeling-CDER (PDF))
SPL Docket 92S-0251 - Content of Labeling - CBER (PDF)
SPL Schema and Stylesheet
FDA SPL Schema for Implementation (zip file last updated October 1, 2012)
FDA SPL stylesheet (zip file last updated October 1, 2012) - send comments to spl@fda.hhs.gov
Download Labels
Resources
Comprehensive NDC SPL Data Elements File (NSDE)
SPL Standard Training
SPL Xforms
SPL Training Material
FDA Electronic Secure Gateway
SPL Software and Conversion Vendors
SPL Terminology
- Business Entity Identifiers
- Business Operation
- Business Operation Qualifier
- Code system object identifiers (OIDs)
- Color
- Combination Product Types
- 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
SPL Terminology Files for Validation
- Active Ingredient-Active Moiety Relationship/Basis of Strength (Excel & XML) (Updated February 21, 2013)(Not applicable for SPL files w/bulk ingredient marketing category.)
- Additional Validation Files (XML)
- Cosmetic Product Category Codes
- Device Product Classification
- OTC Monograph - Active Ingredient (Excel and XML)
- SPL Terminology Validation Files (XML)
- Unique Ingredient Identifiers (UNII) (XML) (Updated February 21, 2013)
- Vaccine Substances Validation File (Excel)(XML)
Terminology for Indexing SPL
- 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.