Transcription of 797 PHARMACEUTICAL COMPOUNDING—STERILE …
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797 PHARMACEUTICAL COMPOUNDING—STERILE …
<797> PHARMACEUTICAL Compounding Sterile Preparations Type of Posting Revision Bulletin Posting Date 22 Nov 2019. Official Date 01 Dec 2019. Expert Committee Compounding Reason for Revision Compliance Postponement In accordance with the Rules and Procedures of the 2015 2020 Council of Experts, USP is postponing the official date of PHARMACEUTICAL Compounding Sterile Preparations <797>. After publication of the revised <797> on June 1, 2019, USP received appeals on certain provisions of the chapter. In accordance with USP's Bylaws, the responsible Expert Committees worked with a sense of urgency to consider the information raised in the appeals and issued decisions on the appeals. As part of the formal USP appeals process, stakeholders who submitted appeals to the compounding chapters had the opportunity to request further review by an appointed Panel, and USP has received three (3) such requests on <797>.
Nov 22, 2019 · Change to read: á797ñ PHARMACEUTICAL COMPOUNDING—STERILE PREPARATIONS ... excessive bacterial endotoxins, 3) variability from the intended strength of correct ingredients, 4) physical and chemical incompatibilities, 5) chemical and physical contaminants, and/or 6) use of ingredients of inappropriate quality.
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