Abstract

Overview of Chapter <797> "Pharmaceutical Compounding - Sterile Preparations": The Potential Impact for Compounding Pharmacists

Author(s): Rahe Hank

Issue: Mar/Apr 2004 - Overview of USP Chapter <797>

Page(s): 89-94

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Abstract

The author discusses the new regulations, enforceable at both the state and federal levels, from the US Pharmacopeial Convention (Chapter <797>) regarding the compounding of sterile preparations. The scope, major implications, preparations, general description of regulation contents and acceptable environments are covered. The main focus of the discussion centers on microbial contamination risk levels; responsibilities of compounding personnel; facilities and equipment; cleanrooms; barrier isolators; verification of compounding accuracy and sterilization; sterilization methods; personnel training and evaluation in aseptic manipulation skills; maintenance of product quality and control after the compounded sterile preparation leaves the pharmacy; packaging, handling and transportation; use and storage; redispensed compounded sterile products; patient monitoring and adverse events reporting and suggested standard operating procedures.

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