The objective of USP <797> is to describe conditions and practices to prevent harm, including death, to patients that could result from:

  • Microbial contamination
  • Excessive bacterial endotoxins
  • Variability in the intended strength of ingredients
  • Chemical and physical contaminants
  • Incorrect type or quality of ingredients in Compounded Sterile Preparations (CSPs)

USP <797> provides practice and quality standards for all persons who prepare CSP drugs and nutrients and all places they are prepared.

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