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
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                              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 
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                                            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 
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                                    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.
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