Transcription of 795 PHARMACEUTICAL COMPOUNDING—NONSTERILE …
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795 PHARMACEUTICAL COMPOUNDING—NONSTERILE …
<795> PHARMACEUTICAL compounding Nonsterile PreparationsType 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 Nonsterile Preparations <795>. After publication of the revised <795> on June 1, 2019, USP received appeals on certain provisions in <795>. 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.
Nov 22, 2019 · monitor and observe compounding activities and must take immediate corrective action if deficient practices are observed. SOPs must describe procedures for the monitoring and observing of compounding activities and personnel. If the facility has only one person in the compounding operation, that person must document that they have obtained
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