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Targeting Success with USP Compounding Standards <795>, <797>, and <800> 2020 Midyear Clinical Meeting and Exhibition Targeting Success with USP Compounding Standards <795>, <797>, and <800> Brian Serumaga, Ph.D., RPh United States Pharmacopeia, Rockville, MD ShewanAziz, Ph.D., RPh Ascension Texas Healthcare, Austin, TX Robert C. Campbell, Pharm.D. The Joint Commission, Oakbrook Terrace, IL Financial Relationship Disclosure ASHP staff, program chairs, presenters, and reviewers report no financial relationships relevant* to this activity. *As defined by the ACCME definition of commercial entity. Learning Objectives 1. Latest updates on USP compounding standards 2. Joint Commission Compounding survey of 2020 in correlation to compounding focus areas of the Joint Commission 3. Describe the leadership approaches and plan of activities by Ascension Health System to ensure organizational readiness for compliance with compounding standards 3 © 2018 USP ©2020 American Society of Health-System Pharmacists Page 1 of 22 Targeting Success with USP Compounding Standards <795>, <797>, and <800> 2020 Midyear Clinical Meeting and Exhibition USP’s Beginning USP was founded in 1820 by 11 physicians, in Washington, D.C. Who We Are The Experts Behind Our Standards ©2020 American Society of Health-System Pharmacists Page 2 of 22 Targeting Success with USP Compounding Standards <795>, <797>, and <800> 2020 Midyear Clinical Meeting and Exhibition The 2020 – 2025 Council of Experts USP Standards for Compounding USP provides 3 types of public standards for compounding USP General Chapters • Establish practice standards to help ensure the quality of compounded preparations. USP Compounded Preparation Monographs • Contain formulations for specific preparations for which there is no suitable commercially available product. USP Monographs for Bulk Substances and Other Ingredients • Provide standards for identity, quality, purity, strength, packaging and labeling for bulk substances and other ingredients that may be used in compounded preparations. Compounding Chapters Overview General Chapters can be: Compendially applicable • Numbered below <1000> and referenced in General Notices, a monograph, or another applicable general chapter below <1000> Informational • Numbered between <1000> and <1999> Specific for dietary supplements • Numbered above <2000> Terminology OR requirements “Shall” “Must” recommendations “Should” ©2020 American Society of Health-System Pharmacists Page 3 of 22 Targeting Success with USP Compounding Standards <795>, <797>, and <800> 2020 Midyear Clinical Meeting and Exhibition CompoundingGeneral Chapters USP standards help promote public health, protect patients and healthcare workers, and address public health challenges. CompendiallyApplicable • <795> Pharmaceutical Compounding – Nonsterile Preparations • <797> Pharmaceutical Compounding – Sterile Preparations Informational • <800> Hazardous Drugs – Handling in Healthcare Settings • <825> Radiopharmaceuticals ‒ Preparation, Compounding, Dispensing, And Repackaging • <1163> Quality Assurance in Pharmaceutical Compounding • <1160> Pharmaceutical Calculations in Prescription Compounding • <1168> Compounding for Phase I Investigational Studies • <1176> Prescription Balances & Volumetric Apparatus How do I know when a USP General Chapter applies? • From a USP compendial perspective, a General Chapter numbered below 1000 becomes compendially applicable – as compared to informational – in the following ways: • Where it is referenced in a monograph; • Where it is referenced in another applicable General Chapter numbered below 1000; or • Where it is referenced in General Notices Applicability of <795>, <797>, and <800> • <795> and <797> are recognized in law and correspondingly made compendially applicable to the practice of compounding through reference in General Notices (See General Notices 3.10.30). Additionally, <795> and <797> are made compendially applicable to specific formulations where there is a USP Compounded Preparation monograph that makes reference to these chapters. • At present, <800> is currently not compendially applicable as it is not currently referenced in monographs, an applicable General Chapter, or General Notices. • However, <800> could be made compendially applicable through the revisions to <795> and <797> if a reference to <800> is added in those chapters. ©2020 American Society of Health-System Pharmacists Page 4 of 22
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