The Home Infusion Compounder's Guide to the Second
Proposed Revision to USP 797
On July 27, 2018, nearly three years after publishing the first proposed revision to Chapter <797> Pharmaceutical Compounding – Sterile Preparations, the United States Pharmacopeial Convention (USP) pre-released the second draft of the much-anticipated revision to the chapter. (The official publication date in the Pharmacopeial Forum (PF) is September 4, 2018.) USP <797> publishes an enforceable standard for practitioners of compounded sterile preparations in all health care settings. While the goal of USP has not changed—to provide minimum practice and quality standards for compounded sterile preparations (CSPs) of drugs and nutrients based on current scientific information and best aseptic practices—the regulation of pharmacy compounding continues to evolve in response to public demand for safe CSPs. This article will review the most significant changes to the recently published draft revision of USP <797>, and offer insights as to the impact they would have, if adopted, on home infusion and
specialty pharmacy providers who engage in sterile compounding.
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