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USP Standards and Regulations Flashcards

6 cards from real CSPT practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.

Read the first 6 USP Standards and Regulations flashcards as text

  1. What is the primary purpose of USP Chapter 797?

    Answer: To establish standards for compounding sterile preparations to prevent patient harm

    USP 797 establishes minimum practice standards for sterile compounding to protect patients from contamination and other adverse outcomes.

  2. How does USP 800 relate to USP 797?

    Answer: USP 800 provides additional requirements for handling hazardous drugs that supplement USP 797

    USP 800 works alongside USP 797, adding specific requirements for containment and safety when compounding hazardous drugs.

  3. What is the difference between Category 1 and Category 2 CSPs?

    Answer: Category 1 has shorter BUDs and may use less stringent conditions; Category 2 has longer BUDs and requires full cleanroom suites

    Category 1 CSPs have shorter BUDs and may be compounded in a segregated compounding area, while Category 2 requires a full cleanroom suite.

  4. What role does the state board of pharmacy play in enforcing USP 797?

    Answer: State boards adopt USP standards into regulations and enforce through inspections

    State boards of pharmacy are the primary enforcers through facility inspections and regulatory actions.

  5. What is a segregated compounding area (SCA) and its limitations?

    Answer: A designated space with an ISO Class 5 PEC but without full cleanroom controls; can only prepare Category 1 CSPs

    An SCA has an ISO Class 5 PEC but lacks the full cleanroom infrastructure. CSPs are limited to Category 1 BUDs.

  6. What is the FDA Drug Quality and Security Act (DQSA) of 2013?

    Answer: It established Section 503A for traditional pharmacies and Section 503B for outsourcing facilities

    The DQSA created two compounding pathways with different regulatory requirements for each.

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