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?

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

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

<p>Compounded Sterile Preparations (A)</p> Signup and view all the answers

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

<p>Compounding accuracy and avoiding contamination (B)</p> 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?

<p>Immediate-Use CSPs (A)</p> 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?

<p>1 hour (C)</p> Signup and view all the answers

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

<p>Emergency or immediate patient administration (A)</p> 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?

<p>3 (C)</p> Signup and view all the answers

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

<p>ISO Class 7 environment (A)</p> Signup and view all the answers

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

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

7

<p>ISO Class 7 environment (B)</p> Signup and view all the answers

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

<p>Beyond-Use Date (C)</p> Signup and view all the answers

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

<p>Emergency or immediate patient administration (A)</p> Signup and view all the answers

Flashcards

USP Chapter 797 Objective

Describes the conditions and practices to prevent harm to patients from microbial contamination during compounding.

What Does USP Chapter 797 Cover?

Applies to the manipulation of compounded sterile preparations before administration to patients.

Variability in Ingredient Strength

Can result in harm to patients if the correct ingredients aren't in the right proportions.

Our Patients Have Never Had a Problem

A phrase used by pharmacists to justify non-compliance with USP Chapter 797. It's a dangerous and misleading statement.

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CSP - Compounded Sterile Preparations

Refers to Compounded Sterile Preparations, which are medications prepared in a sterile environment.

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Focus of USP Chapter 797 on Personnel

The chapter's primary focus is on compounding accuracy and preventing contamination to ensure patient safety.

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Immediate-Use CSPs

A category of CSPs that is exempt from all requirements, involving no contact contamination of ingredients or critical sites. It's used for urgent situations.

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Time Limit for Immediate-Use CSPs

The time limit within which administration must begin after the start of preparation for Immediate-Use CSPs. This ensures the highest level of sterility.

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Purpose of Immediate-Use CSPs

Immediate-Use CSPs are intended to be used in emergency or immediate patient administration situations where time is of the essence.

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Maximum Sterile Products in Low-Risk CSP

The maximum number of sterile products that can be used in a Low-Risk Level CSP compounding process. This helps control contamination risk.

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Environment for Low-Risk CSP

Low-Risk Level CSPs must be maintained in an ISO Class 7 environment at all times to ensure a controlled level of air quality, reducing contamination.

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Low-Risk Level CSPs with 12-Hour BUD

The primary addition in the subsection for Low-Risk Level CSPs with a 12-hour BUD is the use of an ISO 5 device in an uncontrolled air environment to further minimize contamination risks.

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BUD - Beyond-Use Date

Stands for Beyond-Use Date, which refers to the period of time after compounding during which a CSP is considered safe and effective. This helps with medication stability and safety.

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Situations for Using Immediate-Use CSPs

Immediate-Use Category CSPs are intended to be used in emergency or immediate patient administration situations, where time is crucial for treatment.

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Wrong Drug Error

The use of the wrong ingredient or a wrong strength/concentration. This can have serious consequences for patient safety.

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