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Structured Product Labeling (SPL ) - An Overview


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Structured Product Labeling (SPL ) - An Overview

  1. 1. Shakul Hameed Structured Product Labeling (SPL) An Overview
  2. 2. What is SPL?  The Structured Product Labeling (SPL) is a document markup standard developed by Health Level Seven (HL7)  Adopted by FDA as their mechanism for submitting and sharing product information.  SPL is a standard that is used by drug companies, FDA and public to exchange or review or view product information.  SPL is created using Extensible Markup Language (XML) Similar to HTML for WebPages
  3. 3. SPL - Language  SPL is a “language” that computers systems using the SPL standard can “understand”  SPL document is a message that is used to exchange product information (SPL content)  Drug company Creates SPL using SPL standard and Submits SPL to FDA  FDA Processes and validates SPL document using SPL standard  Transmits SPL to public repository (Daily Med)
  4. 4. Information Exchange in SPL SPL is a standard that is used by drug companies, FDA and public to exchange or review or view product information. All three entities use computer systems that “understand” SPL
  5. 5. Communication in Verbal – Different Language
  6. 6. Communication in Verbal – Identical Language
  7. 7. SPL’s Goal is to make the labeling: People friendly - Labeling content in electronic format Improve readability Better access Computer friendly - Medication information that is computer readable Structured labeling content and elements - Computer can “find” a specific section of the labeling and specific elements within labeling
  8. 8. SPL’s Goal is to make the labeling: Information system friendly  Medication information in computer readable form - Easily imported into information systems Publicly available  Content of Labeling (up-to-date version) is made available by the FDA through NLM (DailyMed) to consumers and health information suppliers
  9. 9. The SPL Document An SPL document is comprised of a header and a body Header Body
  10. 10. Major components of an SPL document
  11. 11. The SPL Document  SPL Header identifies and classifies the document and may provide information such as company name, address, responsible persons and title of the document.
  12. 12. The SPL Document  The Body contains the product labeling content itself  Body Contains one or more sections  Sections contain the human readable content (called the narrative block)
  13. 13. The SPL Document
  14. 14. The Basic Structure of SPL
  15. 15. Creation and Validation of SPL Labeling content  SPL Labeling content created by using SPL software tools eg (Xforms its a free software recommend by FDA to create SPL).  After creation of SPL files FDA requested to the submitter to validate your SPL document before sending to the FDA by using Pragmatic Validator (Free Validator tool available online )  After Validating the submission company has to send their SPL document only through ESG to FDA.
  16. 16. SPL Labeling content
  17. 17. Why XML for SPL?  XML – Relatively human-legible – Machine readable – Tags (elements) permit search of key information  XML Documents – created via Notepad, Word Pad, XML editing tools, SPL authoring tools, SPL conversion services, Xforms, etc…  XSL Style sheet – transforms the XML data to be viewed via web browser or printed documents
  18. 18. Transition from Paper to Electronic Registration & Listing  Changes in FD&C Act require electronic registration and listing for human prescription drugs, OTC, animal drug, biologic products – September 2007  Draft Guidance document for electronic drug establishment registration and listing – July 2008  FDA is adopting the use of extensible markup language (XML) files in SPL format as the standard format for the exchange of drug establishment registration and drug listing information.
  19. 19. Three e-Files for Registration & Listing - SPL Format  NDC Labeler Code Request  Establishment Registration  Content of labeling (CoL)/Listing
  20. 20. Order of Submissions for SPL 1. NDC Labeler Request (LCR) and Establishment Registration (ER) SPL 2. CoL/Listing SPL CoL/Listing validates against data submitted in NDC LCR and ER SPL
  21. 21. NDC Labeler Request (LCR)  The National Drug Code (NDC) is a unique product identifier used in the United States for drugs intended for human use  The National Drug Code is a unique 10-digit, 3-segment numeric identifier.  For first time company has to request a new NDC Labeler Code for their product.  Once the NDC Labeler Code is assigned, They can update and resubmit their SPL file to FDA.
  22. 22. NDC Labeler Code Request Data
  23. 23. NDC Labeler Request (LCR) SPL Document
  24. 24. Drug Establishments Registration  Each Registrant (owner/operator firm) must submit one SPL file with registration information for all of its facilities (unlimited amount of domestic or foreign establishments per file)  Updates of information require re-submission of the same updated SPL file (at least annually)  Simplified SPL files are submitted for ‘No Change 'or ‘Out of Business 'notification
  25. 25. Establishment Registration Data
  26. 26. Establishment Registration SPL Document
  28. 28. Benefits of Electronic Registration and Listing  Electronic registration and listing process is more efficient and effective for industry and the Agency  Accurate, up-to-date inventory of marketed drugs  Eliminates data entry errors  Well formed and properly created SPL files can be processed in minutes  Use existing technology and data standard – SPL (Used by FDA since 2005)
  29. 29. Benefits of Electronic Registration and Listing  Data maintenance – Content of Labeling and listing information in one file. – Registrant can list all it’s establishments in one file. – Updates? Update one file instead of creating many paper forms and resubmit.  Eliminates the use of paper forms for listing and registration  24-hour submission window  Manage data using same source (files) as FDA  Annual registration – send one file and automatically register all of your establishments