CSPT USP Standards and Regulations 4 — Questions and Answers
Question 1: Under USP <797>, what is the maximum beyond-use date (BUD) for a Category 2 CSP stored at controlled room temperature when no stability data is available?
- 7 days
- 14 days (Correct answer)
- 30 days
- 45 days
Correct answer: 14 days
USP <797> (2023 revision) assigns Category 2 CSPs a default BUD of 14 days at controlled room temperature when no supporting stability data exists.
Question 2: Which USP chapter establishes standards specifically for hazardous drug handling in healthcare settings?
- USP <795>
- USP <800> (Correct answer)
- USP <825>
- USP <1>
Correct answer: USP <800>
USP <800> sets requirements for receiving, storing, compounding, dispensing, and disposing of hazardous drugs to protect healthcare workers and patients.
Question 3: According to USP <797>, a cleanroom suite classified as ISO 5 is required for which activity?
- Storage of finished CSPs
- Cleaning and gowning of personnel
- Direct compounding and critical manipulations (Correct answer)
- Quality assurance documentation review
Correct 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.
Question 4: What does the term 'Category 1 CSP' refer to under the 2023 USP <797> revision?
- A CSP compounded in a registered outsourcing facility
- A CSP assigned a BUD of 12 hours or less at room temp or 24 hours refrigerated (Correct answer)
- A CSP compounded without sterility testing
- A CSP prepared exclusively for veterinary use
Correct answer: A CSP assigned a BUD of 12 hours or less at room temp or 24 hours refrigerated
Category 1 CSPs under USP <797> (2023) are assigned BUDs of ≤12 hours at controlled room temperature or ≤24 hours refrigerated.
Question 5: Under USP <800>, which of the following drugs is classified as a NIOSH Table 1 hazardous drug requiring the highest level of containment?
- Metformin
- Cyclophosphamide (Correct answer)
- Amoxicillin
- Lisinopril
Correct 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.
Question 6: In the context of USP <797>, what is 'sterility testing' primarily designed to detect?
- Particulate matter above acceptable limits
- Viable microbial contamination in the final CSP (Correct answer)
- Endotoxin concentration exceeding action limits
- Chemical potency of the active ingredient
Correct answer: Viable microbial contamination in the final CSP
Sterility testing per USP <71> detects the presence of viable microorganisms (bacteria and fungi) in the finished compounded sterile preparation.
Question 7: Which environmental monitoring test uses settle plates or active air sampling to measure viable airborne microbial contamination in a cleanroom?
- Bacterial endotoxin test (BET)
- Viable air sampling (Correct answer)
- Particle count monitoring
- Gloved fingertip sampling
Correct 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.
CSPT USP Standards and Regulations 4
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?