CSPT USP Standards and Regulations 5

Question 1

Under USP <797>, which personnel competency assessment must be repeated at least annually for all compounding personnel?

Accepted Answer

Gloved fingertip and thumb sampling

Answer

Gloved fingertip and thumb sampling must be performed initially and at least annually thereafter to verify personnel aseptic technique.

Question 2

What is the primary purpose of the Bacterial Endotoxin Test (BET) described in USP <85>?

Accepted Answer

Quantify gram-negative bacterial endotoxins that could cause pyrogenic reactions

Answer

The BET (Limulus Amebocyte Lysate test) detects and quantifies gram-negative bacterial endotoxins, which cause fever and potentially fatal reactions if injected.

Question 3

According to USP <797>, when must immediate-use CSPs be administered to the patient?

Accepted Answer

Within 4 hours of preparation

Answer

Immediate-use CSPs must be administered within 4 hours of the start of preparation and are subject to less stringent facility requirements.

Question 4

Under USP <800>, which engineering control is specifically required when compounding hazardous drugs that cannot be contained in a CACI (Compounding Aseptic Containment Isolator)?

Accepted Answer

A biological safety cabinet (BSC) Class II Type B2

Answer

When a CACI is not used, hazardous drug compounding must occur in a Class II Type B2 BSC that exhausts 100% of air to the outside.

Question 5

Which USP chapter provides standards for pharmaceutical water systems, including Water for Injection (WFI)?

Accepted Answer

USP <1231>

Answer

USP <1231> (Water for Pharmaceutical Purposes) describes requirements for Purified Water, Water for Injection, and other pharmaceutical-grade waters.

CSPT - Compounded Sterile Preparation Technician Practice Test

CSPT - Compounded Sterile Preparation Technician Practice Test

CSPT USP Standards and Regulations 5