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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
  • Compounding Animal Drugs from Bulk Drug Substances (draft guidance)
  • DSCSA Implementation: Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics (draft guidance)
  • Electronic Drug Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act (final guidance)
  • Electronic Submission of Lot Distribution Reports (final guidance)
  • Format and Content of a REMS Document (draft guidance)
  • Indexing Structured Product Labeling (final guidance)
  • Providing Regulatory Submissions in Electronic Format - Content of Labeling (final guidance)
  • Providing Regulatory Submissions in Electronic Format - Content of the Risk Evaluation and Mitigation Strategies Document Using Structured Product Labeling (final guidance)
  • Providing Regulatory Submissions in Electronic Format - Drug Establishment Registration and Drug Listing (final guidance)
  • Public Availability of Labeling Changes in “Changes Being Effected” Supplements (draft guidance)
  • Registration and Listing of Cosmetic Product Facilities and Products (draft guidance)
  • Registration of Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act (final guidance)
  • Self-Identification of Generic Drug Facilities, Sites, and Organizations (draft guidance)
  • SPL Standard for Content of Labeling Technical Questions and Answers (draft guidance)

SPL Implementation Guide and Validation Procedures

GDUFA SPL Step-by-Step Instructions & Technical Specifications
SPL Dockets

SPL Schema and Stylesheet

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

SPL Terminology

SPL Terminology Files for Validation
Terminology for Indexing SPL

Contact Information

Questions regarding SPL submissions should be directed to: spl@fda.hhs.gov.

Resources For You



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