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Summary of Revised Rules

Official USP Statement

January 1, 2008

The following is a summary of changes to the Rules and Procedures of the 2005-2010 Council of Experts ("rules").

  • Adds Food Chemicals Codex
    • Similar to provisions for Pending Standards, International Standards: web-based public notice and comment
    • Provisions include processes for expedited and immediate standards where circumstances warrant
    • As with USP-NF monographs, generally require that accompanying reference standard be available
  • Revises Project Team provisions to give Project Teams more autonomy, decrease involvement of USP staff and volunteers
  • Provides clarification of USP processes regarding:
    • Intent to Revise
    • Errata
    • Approved for Inclusion
    • Information Monographs (vet and radiopharmaceuticals)
    • Harmonized Text
    • Expansion of FDA Liaison provisions to include other domestic and foreign government representatives
  • Indicates that Expert Committee minutes will be posted, with the exception of the closed portions.
  • Includes other minor corrections/clarifications