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>?
- USP (United States Pharmacopeia)
- What is the main purpose of USP <797>?
- To set minimum standards for compounding sterile preparations (CSPs) that prevent microbial, chemical, and physical contamination
- What is the main purpose of USP <800>?
- To protect healthcare personnel, patients, and the environment from exposure to hazardous drugs
- What is a segregated compounding area (SCA)?
- 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?
- 12 hours
- What is the maximum BUD for a Category 1 CSP under refrigeration?
- 24 hours
- Where must Category 2 CSPs be compounded?
- 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?
- ISO Class 5
- What ISO classification is required for a sterile compounding buffer room?
- ISO Class 7
- What ISO classification is required for the anteroom of a sterile compounding suite?
- ISO Class 8
- Name the four types of primary engineering controls (PECs) used in sterile compounding.
- 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?
- Positive pressure
- What pressure relationship must a hazardous drug sterile compounding room maintain relative to adjacent areas?
- Negative pressure
- What is the minimum required air changes per hour (ACPH) in an ISO Class 7 buffer room?
- 30 ACPH
- What is the minimum required air changes per hour (ACPH) in an ISO Class 8 anteroom?
- 20 ACPH