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Physical Environment Provisions of USP <797> “Pharmaceutical Compounding – Sterile Preparations” Third Edition

By Benjamin Leutze

General Chapter <797>, “Pharmaceutical Compounding — Sterile Preparations,” of the U.S. Pharmacopeia addresses policies and practices for the preparation, packaging and storage of compounded sterile preparations (CSPs) before they are administered to patients. USP <797> 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. The chapter emphasizes individual training and evaluation of those who compound sterile preparations. 

This monograph discusses only the physical environment aspects of USP <797>, and is intended for the use of health care facility managers. It will aid those preparing for compliance with USP <797> by:

• 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