This Recommended Practice (RP) provides guidance for the design, performance, and facility operations of pharmaceutical sterile compounding controlled environments in accordance with USP 797 ”Pharmaceutical Compounding – Sterile Preparations.” This RP is intended for designers, facility directors, operators, qualified/accredited contractors, and quality assurance of pharmaceutical compounding controlled environments.

This Recommended Practice is being developed by Working Group 48 of the IEST Contamination Control Division (WG-CC048).