Structured Product Labeling (SPL) is an XML standard used by the United States Food and Drug Administration (FDA) to facilitate the communication of drug labeling data reliably among various groups such as hospitals, doctors, pharmacies, and the general public. SPL is both an HL7- and ANSI-approved standard.
The FDA Center for Drug Evaluation and Research (CDER) division has required since 2005 that all new and updated human prescription products be provided in SPL. Other FDA divisions such as CBER (Biologics), CVM (Veterinary Medicine), and ONP (Non-Prescription and Over-the-Counter drugs) require SPL filing since June 2009. CDRH (Medical Devices) is expected to require SPL filing in late 2011.
DCL Experience
Conversion of data and documents to XML - SPL
Support for prescription drugs, over-the-counter (OTC) products, animal and veterinary medicines, homeopathic products, and bulk ingredients
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
Differentiators
In-depth experience with SPL
Ability to handle any volume
Member, SPL Working Group
DCL has been in the conversion business over 30 years
Guaranteed performance
Capability to implement content reuse program to identify reusable text and burst documents into modules for process efficiency and improvements [this does not apply to SPL]
Serving all industries
Authored chapters on 'Legacy Data Conversion' in Bill Kasdorf's Columbia Guide to Digital Publishing
Authored chapters on 'Data Conversion' in Charles Goldfarb's The XML Handbook
Experienced with most foreign languages including Latin-based and double-byte characters
Experienced with Unicode-based content conversions
Three-Phase Process
Client completed DCL-designed spreadsheet for drug product listing information and provides source labels/packaging labels
Production Conversion
Delivery of SPL folder ready for gateway submission