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Resource Center
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SPL Conversion – Fact Sheet
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XML Structured Product Labeling for the Pharmaceutical Industry
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What is it:
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SPL (Structured Product Labeling) is an XML standard used by the FDA community to facilitate communicating drug labeling data reliably among various groups such as the FDA, hospitals, prescribing organization, doctors, and the general public. SPL is both an HL7- and ANSI-approved standard.
The FDA (US Food & Drug Administration) CDER division has provided guidance since 2005 that all human prescription products be provided in SPL. Other FDA divisions such as CBER (Biologics), CVM (Veterinary Medicine), and ONP (Office of Nonprescription Products, responsible for OTC, or over the counter products) required SPL filing starting in June, 2009. CDRH (Medical Devices) is expected to require SPL filing in 2010.
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Capability:
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Conversion of data & documents to XML - SPL
- Support for prescription drugs, over the counter (OTC) products and animal & veterinary medicines
- XML data is guaranteed to conform to FDA SPL requirements
- Establishment Registrations, NDC Labeler Code Requests, and Drug Product Listings/Content-of-Labeling are all supported
- High volume bulk conversion as well as individual labels
- Support for organizations developing internal capabilities
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| DCL Experience:
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- Member, SPL Working Group
- Over 1,900 labels created, for more than 125 sponsors
- 27 years in the conversion business
- Authored 'Legacy Data Conversion' chapter in
Columbia Guide to Digital Publishing
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Differentiators:
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- In-depth experience with SPL
- Ability to handle any volume
- Guaranteed performance
- Capability to implement content reuse program to identify reusable text and burst documents into modules for process efficiency improvements.
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Languages:
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Experience with most foreign languages including Latin based and double-byte characters.
- Experience with Unicode.
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Partnerships:
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- PTC Arbortext (XML Authoring)
- i4i (Authoring Software)
- Quark (Authoring Software)
- Documentum (Content Management)
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Process:
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Three-phase process consisting of:
- Client completes DCL-designed spreadsheet for drug product listing information and provides source labels/packaging labels
- Production Conversion
- Delivery of SPL folder ready for gateway submission
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For More Info:
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Data Conversion Laboratory, Inc.
http://www.dclab.com
(505) 275-2223
e-mail SPL@dclab.com
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Other References:
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- DCL SPL R4 FAQ page
http://www.dclab.com/spl_r4.asp
- FDA SPL Resources Page
http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
- CDER Requirements for PLR Prescribing Information
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/
LawsActsandRules/ucm085169.htm
- The Real Story on XML at
http://www.dclab.com/realxml.asp
- 7½ Secrets for Managing XML Migration at
http://www.dclab.com/7.5secrets.asp
- The Future of Labeling - Pharmaceutical Executive
http://www.pharmexec.com/pharmexec/article/articleDetail.jsp?id=146595
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Events
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- The Summer XML 2009 Conference, July 27-28, 2009, McKimmon Conference Center, Raleigh, NC
- DIA - eDrug Listing and Establishment Registration FDA and Industry: Overview and Lessons Learned on SPL, August 11, 2009, Philadelphia, PA
- Joint Annual Meeting of the Society of American Archivists and the Council of State Archivists, August 13-14, 2009, Austin, TX
- The Real World DITA 2009 Conference, September 14-16, 2009, McKimmon Conference Center, Raleigh, NC
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