The FDA regulatory framework and USP <797>, 2023 standards of practice applicable to compounding. |
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Personnel training and evaluation, and roles and responsibilities as outlined in USP <797>, § 2, 2023. |
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Standard Operating Procedures and related Documentation as identified throughout USP <797>, 2023. |
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The different characteristics related to immediate-use, Category 1, Category 2, and Category 3 compounding. |
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Facility and engineering controls related to sterile compounding as outlined in USP <797> § 4 & 5, 2023. |
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Microbiological air and surface monitoring as outlined in USP <797> § 6, 2023. |
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Equipment, supplies, and component handling, and management as outlined in USP <797> § 9, 2023. |
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Cleaning and disinfecting as outlined in USP <797> § 6, 2023. |
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Pharmaceutical calculations related to sterile dosage forms. |
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Aseptic processing, and release inspection and testing. |
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Quality Assurance and Quality Control procedures, activities, and oversight as outlined in USP <797>, § 18, 2023. |
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CSP Handling, storage, packaging, shipping, and transport as outlined in USP <797> § 19, 2023. |
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The compounding and management of Allergenic Extracts. |
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Hazard communication program, and API risk management as identified in USP <800>, 2020. |
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Standard Operating Procedures and related Documentation as identified throughout USP <800>, 2020. |
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Personal protective equipment and containment-engineering controls for hazardous drug compounding. |
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Deactivating, decontaminating, cleaning, and disinfecting for hazardous drug compounding. |
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Environmental wipe sampling for hazardous drug compounding. |
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Labeling, packaging, transport, and disposal of hazardous drugs. |
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Dispensing, compounding, and administering hazardous CSPs. |
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