Slide Presentation of the 2007 Annual Meeting of AHRQ

Structured Product Labeling (SPL)

• HL7 v3 Standard, Sponsored by FDA
  • 2004/5 Electronic Labeling Guidance (SPL R2)
    • Includes medication model
  • 2005/6 Physicians Labeling Rule (PLR, SPL R3)
    • Includes clinical knowledge model
  • 2006/7 Launch of DailyMed
    • Now contains over 3257 SPL labels
    • Currently only original innovator labels
  • 2007/8? E-Listing Rule (SPL R4, in preparation)
    • Will include all marketed drugs (covering all drug NDC codes)
    • Provisions for devices, veterinary, and dietary supplements, food labels included in SPL R4