Compounded Sterile Preparation - USP 797 Compliance Manual

MCN’s Compounded Sterile Preparation USP <797> Compliance Manual is your resource for sterile pharmaceutical compounding and sterile preparations. This manual provides policies and procedures outlining all requirements of USP <797>, as well as TJC’s Medication Management Standards. Policies include Sterile Compounding – Staff Competency, Quality Assurance, Sterility and Bacterial Endotoxin Testing, Sterilization Methods, Equipment Maintenance and much more!

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ChangesTable of Contents - TJC standardsCopyrightDisclaimer
1001 - Definitions and Abbreviations1002 - CSPs Policies and Procedures1003 - Compounded Sterile Preparations - Operating Procedures Manual1004 - Sterile Compounding - Staff Competency1005 - Compounding Staff Gloved Fingertip Sampling1006 - Work Surface Sampling1007 - Compounded Sterile Preparations (CSPs)1008 - Drug Compounding1009 - CSP Microbial Contamination Risk Levels1010 - Quality Assurance Procedures1011 - Immediate-Use CSPs1012 - Use of Multiple Dose Vials (MDVs)1013 - Chemotherapy Handling1014 - Verification of Compounding Accuracy and Sterilization1015 - Sterilization Methods1016 - High-Risk Level CSPs1017 - Directions for Use of Steam Sterilizer1018 - Attest Biological Indicator Use1019 - Sterilization Performance Records1020 - Critical Sites1021 - Clean Room (Buffer Area)1022 - Physical Environment Requirements for Sterile Compounding1023 - Ante-Area1024 - LAFWs or Barrier Isolators1025 - Laminar Airflow Hood Maintenance1026 - Engineering Control Performance Verification1027 - Pressure Differential Monitoring1028 - Air Quality Checks1029 - Infection Control1030 - Disposal of Sharps1031 - Cleaning and Disinfecting Solutions1032 - Cleaning Supplies1033 - Cleaning and Disinfection of the Sterile Compounding Areas - Pharmacy Responsibilities1034 - Cleaning of the Clean Room and Ante-Area - Environmental Services Responsibilities1035 - Attire in the Buffer Area (Clean Room)1036 - Hand Scrub1037 - Aseptic Technique1038 - Ingredients1039 - Sterile Ingredients and Components1040 - Non-Sterile Ingredients and Components (High-Risk)1041 - Compounding Equipment Maintenance1042 - Automated Compounding Devices (ACDs)1043 - Finished Preparation Release Checks and Tests1044 - Sterility and Bacterial Endotoxin Testing for High-Risk Level CSPs1045 - Storage1046 - Refrigerated Drug Storage1047 - Beyond-Use Dates1048 - Packaging, Handling and Transport1049 - Packing and Transporting CSPs to Outside Locations1050 - Storage of CSPs Outside of the Compounding Pharmacy1051 - CSP Storage on Patient Care Units1052 - Administration of CSPs - Nursing1053 - Re-Dispensing of CSPs1054 - Patient/Caregiver Education1055 - Patient/Caregiver CSP Competence Assessment Form1056 - Patient Monitoring1057 - Adverse Drug Reaction Reporting1058 - Adverse Drug Reaction Reporting Form1059 - Potential Adverse Drug Reaction Form1060 - Adverse Drug Report Form1061 - Performance Improvement Plan for Compounded Sterile Preparations1062 - Medication Management Program