1. Shakul Hameed
Structured Product Labeling (SPL)
An Overview

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. 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. 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. Communication in Verbal – Different Language

6. Communication in Verbal – Identical Language

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. 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. The SPL Document
An SPL document is comprised of a header and a body
Header
Body

10. Major components of an SPL document

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. 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. The SPL Document

14. The Basic Structure of SPL

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 http://validator.pragmaticdata.com/validator-lite/ )
 After Validating the submission company has to send their
SPL document only through ESG to FDA.

16. SPL Labeling content

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. 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. Three e-Files for Registration & Listing - SPL
Format
 NDC Labeler Code Request
 Establishment Registration
 Content of labeling (CoL)/Listing

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. 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. NDC Labeler Code Request Data

23. NDC Labeler Request (LCR) SPL Document

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. Establishment Registration Data

26. Establishment Registration SPL Document

27. “ROAD MAP” FOR CREATING AND SUBMITTING
SPLTO FDA

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. 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