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USP Standards and Regulations Flashcards

7 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 7 USP Standards and Regulations flashcards as text

  1. Under USP , what is the maximum beyond-use date (BUD) for a Category 2 CSP stored at controlled room temperature when no stability data is available?

    Answer: 14 days

    USP (2023 revision) assigns Category 2 CSPs a default BUD of 14 days at controlled room temperature when no supporting stability data exists.

  2. Which USP chapter establishes standards specifically for hazardous drug handling in healthcare settings?

    Answer: USP

    USP sets requirements for receiving, storing, compounding, dispensing, and disposing of hazardous drugs to protect healthcare workers and patients.

  3. According to USP , a cleanroom suite classified as ISO 5 is required for which activity?

    Answer: Direct compounding and critical manipulations

    ISO 5 conditions (≤100 particles ≥0.5 µm per ft³) are required for the direct compounding environment where critical manipulations occur.

  4. What does the term 'Category 1 CSP' refer to under the 2023 USP revision?

    Answer: A CSP assigned a BUD of 12 hours or less at room temp or 24 hours refrigerated

    Category 1 CSPs under USP (2023) are assigned BUDs of ≤12 hours at controlled room temperature or ≤24 hours refrigerated.

  5. Under USP , which of the following drugs is classified as a NIOSH Table 1 hazardous drug requiring the highest level of containment?

    Answer: Cyclophosphamide

    Cyclophosphamide is an antineoplastic agent listed on NIOSH Table 1, requiring full closed-system drug transfer device (CSTD) and containment primary engineering controls.

  6. In the context of USP , what is 'sterility testing' primarily designed to detect?

    Answer: Viable microbial contamination in the final CSP

    Sterility testing per USP detects the presence of viable microorganisms (bacteria and fungi) in the finished compounded sterile preparation.

  7. Which environmental monitoring test uses settle plates or active air sampling to measure viable airborne microbial contamination in a cleanroom?

    Answer: Viable air sampling

    Viable air sampling (active or passive) is the environmental monitoring method used to measure living microbial counts in ISO-classified cleanroom air.