USP 797 sterile compounding standards and USP 800 hazardous drug handling requirements tested on the NAPLEX.
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- Which organization publishes chapters <797> and <800>?
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USP (United States Pharmacopeia)- What is the main purpose of USP <797>?
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To set minimum standards for compounding sterile preparations (CSPs) that prevent microbial, chemical, and physical contamination- What is the main purpose of USP <800>?
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To protect healthcare personnel, patients, and the environment from exposure to hazardous drugs- What is a segregated compounding area (SCA)?
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An unclassified space containing only a primary engineering control (PEC), used to compound Category 1 CSPs- What is the maximum beyond-use date (BUD) for a Category 1 CSP at controlled room temperature?
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12 hours- What is the maximum BUD for a Category 1 CSP under refrigeration?
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24 hours- Where must Category 2 CSPs be compounded?
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In a classified cleanroom suite (an ISO Class 7 buffer room with an ISO Class 8 anteroom)- What ISO air cleanliness classification must a primary engineering control (PEC) provide?
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ISO Class 5- What ISO classification is required for a sterile compounding buffer room?
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ISO Class 7- What ISO classification is required for the anteroom of a sterile compounding suite?
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ISO Class 8- Name the four types of primary engineering controls (PECs) used in sterile compounding.
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Laminar airflow workbench (LAFW), biological safety cabinet (BSC), compounding aseptic isolator (CAI), and compounding aseptic containment isolator (CACI)- What pressure relationship must a nonhazardous sterile compounding buffer room maintain relative to its anteroom?
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Positive pressure- What pressure relationship must a hazardous drug sterile compounding room maintain relative to adjacent areas?
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Negative pressure- What is the minimum required air changes per hour (ACPH) in an ISO Class 7 buffer room?
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30 ACPH- What is the minimum required air changes per hour (ACPH) in an ISO Class 8 anteroom?
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20 ACPH
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