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In January 2004, USP Chapter <797> "Pharmaceutical Compounding-Sterile Preparations", became the first official, enforceable requirement for the compounding of sterile preparations. The goal of USP <797> is to protect patients from the harm that can result from microbial contamination or medication errors in compounded sterile preparations.
USP Chapter <797> has been revised and the new revision, which dictates compounding be performed under ISO 5 (Class 100) conditions, became official on 01 June 2008. Compliance with USP Chapter <797> is a challenging requirement that will be strictly enforced.
For more detailed information about USP <797> compliance, visit www.usp797.org.
