Physical Environment Provisions of USP <797> “Pharmaceutical Compounding —Sterile Preparations” (Second Edition)

Physical Environment Provisions of USP 797 ; “Pharmaceutical Compounding – Sterile Preparations” Second EditionBenjamin Leutze

General Chapter <797>, “Pharmaceutical Compounding-Sterile Preparations,” of the U.S. Pharmacopeia addresses policies and practices for preparation, packaging, and storage of compounded sterile preparations (CSPs) before they are administered to patients. The standard applies to all places where CSPs are prepared (e.g., hospitals, clinics, pharmacies, and emergency rooms) and to all persons, regardless of profession, whose work involves preparation of CSPs. Contact is the most likely source of clinically significant microbial contamination during pharmaceutical compounding, and proper hand hygiene is critical. The standard also stresses the need for environmental sampling as part of comprehensive quality management. This ASHE monograph discusses only the physical environment aspects of USP <797> and is intended for the use of health care facility managers.

  • Defining CSPs
  • Explaining enforceability
  • Describing environmental quality and control
  • Discussing physical environment considerations including HVAC layout
  • Reviewing initial certification process and ongoing compliance requirements
  • Providing an operational checklist

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