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 - Public Availability of Labeling Changes in “Changes Being Effected” Supplements (PDF)
- Guidance for Industry: Indexing Structured Product Labeling (Final) (PDF)
- Guidance for Industry: Self-Identification of Generic Drug Facilities, Sites, and Organizations (DRAFT) (PDF)
- Guidance for Industry: Electronic Submission of Lot Distribution Reports (FINAL) (PDF)
- Guidance for Industry - Electronic Drug Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act (DRAFT)(PDF)
- Guidance for Industry - Registration of Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act (FINAL) (PDF)
- Guidance for Industry - DSCSA Implementation: Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics (DRAFT)(PDF)
- Providing Regulatory Submissions in Electronic Format — Content of the Risk Evaluation and Mitigation Strategies Document Using Structured Product Labeling (FINAL)(PDF)
- Compounding Animal Drugs from Bulk Drug Substances - Guidance for Industry (DRAFT)(PDF)
- Guidance for Industry - Format and Content of a REMS Document (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 Docket 92S-0251 - Blood and Tissue Establishment Registration and Product Listing (PDF
SPL Schema and Stylesheet
- FDA SPL Schema for Implementation (zip file last updated April 25, 2016)
- FDA SPL stylesheet (zip file last updated October 24, 2016) - send comments to [email protected]
Download Labels
Resources
- Comprehensive NDC SPL Data Elements File (NSDE)
- Indexing SPL Fact Sheet
- SPL Standard Training
- SPL Xforms
- SPL Training Material
- FDA Electronic Secure Gateway
- SPL Software and Conversion Vendors
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- CDER Direct
- CVM SPL Xforms
- REMS SPL Sample (XML)
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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
- Geopolitical Entities, Names, and Codes (GENC)
- Lot Distribution Data - Distribution Codes
- 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)(Not applicable for SPL files w/bulk ingredient marketing category.)
- Additional Validation Files (XML)
- Blood Donor Type (Excel and XML)
- Blood Establishment Function Type (Excel and XML)
- Blood Establishment Type (Excel and XML)
- Blood Establishment Type of Ownership (Excel and XML)
- Blood Product Type (Excel and XML)
- Business Operation Qualifiers (XML)
- Combination Product Category Types (XML and Excel)
- Cosmetic Product Category Codes
- DEA Schedule
- Device Product Classification
- Designated Medical Gas
- Dosage Form (XML)
- Lot Distribution Data - Distribution Codes
- Marketing Categories (XML)
- Medication Guides (Excel and XML)
- OTC Monograph - Active Ingredient (Excel and XML)
- Physician Labeling Rule Content of Labeling & Application Number Validation (Excel and XML)
- Product Concept Validation (CSV)
- REMS Approval (XML)
- REMS Protocol (XML)
- REMS Requirements (XML)
- REMS Stakeholder (XML)
- SPL Terminology Validation Files (XML)
- Tissue Donor Type (Excel and XML)
- Tissue Establishment Function Type (Excel and XML)
- Tissue Establishment Type (Excel and XML)
- Tissue Product Group (Excel and XML)
- Tissue Product Type (Excel and XML)
- Unique Ingredient Identifiers (UNII) (XML)
- 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: [email protected].