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 · 16.1 Use of Compounded Multiple-Dose CSPs 16.2 Use of Compounded Single-Dose CSPs and CSP Stock Solutions 17. SOPs 18. QUALITY ASSURANCE AND QUALITY CONTROL 18.1 Notification About and Recall of Out-of-Specification Dispensed CSPs 18.2 Complaint Handling 18.3 Adverse Event Reporting 19. CSP HANDLING, STORAGE, …
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