CSPT USP Standards and Regulations 4

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?

Accepted Answer

14 days

Answer

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?

Accepted Answer

USP <800>

Answer

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?

Accepted Answer

Direct compounding and critical manipulations

Answer

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?

Accepted Answer

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

Answer

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?

Accepted Answer

Cyclophosphamide

Answer

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

CSPT - Compounded Sterile Preparation Technician Practice Test

CSPT - Compounded Sterile Preparation Technician Practice Test

CSPT USP Standards and Regulations 4