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Slide Presentation of the 2007 Annual Meeting of AHRQ

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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

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