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Revisions to USP <797> Announced
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On Friday, September 25, the United States Pharmacopeial Convention (USP) released an advance copy of its proposed revisions to General Chapter <797> - Pharmaceutical Compounding – Sterile Preparations. The Compounding Expert Committee has been reviewing this chapter since 2010 with an eye towards clarifying and incorporating input from the compounding community. This will represent the first time in seven years that USP has announced an update to <797>.

Some of the major changes include: reorganization of existing sections, categorizing the previous three types of compounded sterile preparation (CSP) microbial risk categories (e.g. low-, medium-, and high-risk) into two categories (Category 1 and 2), removing references to handling of hazardous drugs and cross-referencing to pending USP <800>, and adding a new definition of “in-use time” to describe when a CPS must be used after it has been opened or punctured.  
On November 2, 2015, the proposed revisions will be formally published and opened for public comment. All comments are due by January 31, 2016. You can review the proposed changes now by visiting <797> Pharmaceutical Compounding—Sterile Preparations. This week, the IACP Legislative Committee will begin assessing each of the changes and encourages all members engaged in sterile compounding to send their comments to the Committee at

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