revisions to usp compounding standards 795 and 797 brian serumaga phd november 2022 approach to revisions after the appeals stakeholder engagement reviewed feedback including pf public comments and issues raised ...
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...Revisions to usp compounding standards and brian serumaga phd november approach after the appeals stakeholder engagement reviewed feedback including pf public comments issues raised in held semi structured interviews may roundtable session july open forums september identified key discussion topics as a framework also had general considerations throughout review process scientifically robust risk based assigning buds physical chemical stability sterility assurance operational implications balancing need for patient access cost effective compounded preparations with rigorous quality on regulatory oversight enforcement overview of revised chapter pharmaceutical nonsterile outline introduction scope sops personnel training evaluation control personal hygiene garbing cnsp packaging transporting buildings facilities documentation cleaning sanitizing glossary equipment components master formulation records release inspections testing labeling establishing beyond use dates...