Status and Update to General Chapter <797> Pharmaceutical Compounding – Sterile Preparations

The revised chapter <797>, official June 1, 2008 is available in the following publications:

The chapter contains the following topics:
  • Introduction and Organization of the Chapter
  • CSP Microbial Contamination Risk Levels
  • Single–Dose v. Multiple Dose Containers
  • Hazardous Drugs as CSPs
  • Radiopharmaceuticals as CSPs
  • Allergen Extracts as CSPs
  • Sterilization Methods
  • Environmental Quality and Control
  • Exposure of Critical Sites
  • Placement of Primary Engineering Controls
  • Additional Personnel Requirement
  • Personnel Cleansing and Garbing
  • Disinfectant and Cleaning
  • Five Appendices