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For the purposes of this chapter, CSPs include any of the following: The sections in this chapter are organized to facilitate practitioners’ understanding of the fundamental accuracy and quality practices of CSPs.Low-risk compounding includes using sterile needles and syringes to transfer sterile liquids from manufacturer-sealed ampules or vials to sterile devices or other sterile packages.For case-by-case determination of risk level, please consult the licensed healthcare professional who supervises compounding at your pharmacy.Low-risk conditions—Compounding with aseptic manipulations using only sterile ingredients, products and devices in ISO Class 5 or higher air quality will generally fall in a low-risk category.A stability-indicating method is used to determine stability of a drug and used to establish the Beyond-Use Date.Overview of USP 797 – June 1, 2008 Update The purpose of U. Pharmacopeia (USP) 797 is to provide the practice standards to help ensure that compounded sterile preparations are of high quality, and is for the pre-administration phase of sterile preparations.Major revisions of the General Chapter include: will be published for public comment in Pharmacopeial Forum (PF) 41(6) [Nov.–Dec.

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Type of Posting: Revision Bulletin Posting Date: 22–Nov–2013 Official Date: 01–Jan–2014 Expert Committee: Compounding Expert Committee Reason for Revision: Patient Safety In accordance with the Rules and Procedures of the 2010-2015 Council of Experts, the Compounding Expert Committee has revised the General Chapter Pharmaceutical Compounding—Nonsterile Preparations.

Comments should include corresponding line number to the proposed revisions to the General Chapter.

Comments will be accepted until January 31, 2016, the end of the comment period for PF 41(6).

USP Chapter 797 sets compounding risk levels based on the likelihood of contaminating a compounded sterile preparation (CSP) with microorganisms, spores, endotoxins or other foreign material.

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