SPL Working Group

SPL Working Group Overview

(Sub Groups)
The SPL Standard was initially developed by a small group within the HL7 Regulated Clinical Research Information Management Technical Committee. HL7 is an independent and international provider of healthcare standards. PhRMA HL7 Task Group formed the SPL Working Group in January 2004 to further the work of the initial development team.

Composition of the SPL Working Group

The group has grown significantly since its inception in 2004. Participants come from:
  • Industry sponsors of human and veterinary (pharmaceuticals, generic pharmaceuticals, biologics, devices, over-the-counter) products submitted to the FDA
  • FDA representatives
  • Vendors
  • HL7 representation

The SPL Working Group has a Implementation Technical Team and a Process Communications Forum. Additionally, a variety of subteams address specific topical and subject issues. Current subteams include: Biologics, VetMeds, Devices, Generics, Establishment Registration Lifecycle, Labeling Content Lifecycle and Over-the-Counter (OTC) Products. The newest subteam is the Downstream Uses group.

Current Objectives of the SPL Working Group

  • Raise industry awareness concerning SPL (on-going)
  • Sponsor industry webcasts and meetings, as appropriate
  • Provide forum for discussion of issues, best practices, and FDA documentation of SPL
  • Review changes to HL7 SPL model
  • Review changes to XSL Stylesheet
  • Produce revisions to Implementation Guide in line with schema releases
  • Determine future direction of SPL Standard

Links/Additional Resources

Downstream Uses of SPL

  • Drugs.comSearch for a product. Select the "professional" label to see the SPL (with the drug listing table at the end)