Transcription of General Chapters <797> Pharmaceutical Compounding ...
{{id}} {{{paragraph}}}
Example: marketing
General Chapters <797> Pharmaceutical Compounding ...
General Chapters <797> Pharmaceutical Compounding sterile Preparations Type of Posting Revision Bulletin Posting Date24 Apr 2020 Official Date01 May 2020 Expert CommitteeCompounding Reason for Revision Compliance Appeals Panel Decision In accordance with the Rules and Procedures of the 2015 2020 Council of Experts, USP is updating the status of Pharmaceutical Compounding sterile Preparations <797> based on the Appeals Panel decision. The currently official <797>, last revised in 2008, remains official. On June 1, 2019, USP published revisions to General Chapter <795> for nonsterile Compounding and General Chapter <797> for sterile Compounding , as well as a new General Chapter <825> for radiopharmaceuticals. After publication of the revised and new Compounding standards, USP received appeals on certain provisions in <795>, <797>, and <825>. In accordance with USP s Bylaws, the responsible Expert Committees considered the information raised in the appeals and issued decisions on the appeals (see Decisions on Appeals to USP <795> and <797> and <825>).
Apr 24, 2020 · Sterile compounding differs from nonsterile compounding (see Pharmaceutical Compounding—Nonsterile Preparations ¢795) primarily by requiring the maintenance of² sterility when compounding exclusively with sterile ingredients and components (i.e., with immediate-use CSPs, low-risk level
Loading..
Tags:
Information
Domain:
Source:
Link to this page:
Please notify us if you found a problem with this document: