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PHAR635: USP 797 Chapter 5 Quiz

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Questions and Answers

What is the objective of USP Chapter 797?

To promote excessive bacterial endotoxins

To describe conditions and practices to prevent harm to patients resulting from microbial contamination (correct)

To encourage variability in the intended strength of correct ingredients

To justify non-compliance of pharmacists with USP Chapter

What does USP Chapter 797 apply to?

Transportation and storage of non-sterile dosage forms

Post-administration manipulations of compounded sterile preparations

Manufacturing of non-sterile dosage forms

Pre-administration manipulations of compounded sterile preparations (correct)

What could result from variability in the intended strength of correct ingredients?

Minimization of unintended chemical and physical contaminants

Decrease in microbial contamination

Harm to patients (correct)

Improvement in the quality of compounded sterile preparations

Why is the statement 'Our patients have never had a problem' used by pharmacists?

To justify their non-compliance with USP Chapter (A) Signup and view all the answers

What does CSP stand for in the context of compounding personnel?

Compounded Sterile Preparations (A) Signup and view all the answers

What is the primary focus of the chapter regarding compounding personnel?

Compounding accuracy and avoiding contamination (B) Signup and view all the answers

Which category of CSPs is exempt from all requirements and involves no contact contamination of ingredients or critical sites?

Immediate-Use CSPs (A) Signup and view all the answers

In the Immediate-Use Category, what is the time limit within which administration must begin after the start of preparation?

1 hour (C) Signup and view all the answers

What is the primary condition under which Immediate-Use CSPs are intended to be used?

Emergency or immediate patient administration (A) Signup and view all the answers

What is the maximum number of sterile products that can be used in a Low-Risk Level CSP compounding?

3 (C) Signup and view all the answers

In which type of environment must Low-Risk Level CSPs be maintained at all times?

ISO Class 7 environment (A) Signup and view all the answers

What is the primary addition in the subsection for Low-Risk Level w/12 hour BUD?

ISO 5 device in an uncontrolled air environment (C) Signup and view all the answers

7

ISO Class 7 environment (B) Signup and view all the answers

What does BUD stand for in the context of risk levels for CSPs?

Beyond-Use Date (C) Signup and view all the answers

In which situations are Immediate-Use Category CSPs intended to be used?