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 Labeling

• FDALabel: FDA’s web-based application designed to perform customizable searches of over 140,000 labeling for human prescription drug; nonprescription drugs; and labeling for other products (e.g., animal nonprescription and animal prescription drugs, cosmetics, dietary supplements, medical devices, medical foods). FDALabel and DailyMed have the same database but have different search functions and different displays of search results.
• FDA Online Label Repository

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  
• CDER Direct
• CVM SPL Xforms
• REMS SPL Sample (XML)

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].

Resources For You

• NCPDP WG2 SPL Activities Task Group