CSPT - Compounded Sterile Preparation Technician USP Standards and Regulations Questions and Answers 2

Question 1

What is the primary purpose of USP Chapter 797?

Accepted Answer

To establish standards for compounding sterile preparations to prevent patient harm

Answer

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

Question 2

How does USP 800 relate to USP 797?

Accepted Answer

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

Answer

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

Question 3

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

Accepted Answer

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

Answer

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

Question 4

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

Accepted Answer

State boards adopt USP standards into regulations and enforce through inspections

Answer

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

Question 5

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

Accepted Answer

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

Answer

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

CSPT - Compounded Sterile Preparation Technician Practice Test