Question 1

What is the Meaning of USP Chapter 797?

Accepted Answer

USP Chapter 797 establishes comprehensive standards for compounding sterile preparations to ensure patient safety and product quality. This official compendium provides requirements applicable to all persons who prepare compounded sterile preparations, outlining practices and quality standards for compounding sterile drug products for human and animal use. It serves as a critical reference for pharmaceutical practice globally.

Question 2

What is the Context of USP Chapter 797?

Accepted Answer

This chapter operates within the regulated environment of pharmacy practice and healthcare facilities where sterile medications are prepared, stored, and dispensed. It directly influences medication administration pathways, impacting patient care delivery across various clinical settings. Its principles are fundamental to maintaining sterility in the preparation of injectable medications, ophthalmic solutions, and other sterile dosage forms.

Question 3

What is the Significance of USP Chapter 797?

Accepted Answer

Adherence to USP Chapter 797 is vital for mitigating risks of contamination, infection, and adverse drug reactions in patients receiving sterile compounded medications. Proper sterile compounding protects vulnerable individuals, such as those with compromised immune systems or patients requiring specific hormone therapies, from potentially life-threatening microbial exposure. This standard ensures the therapeutic integrity and safety of compounded preparations, directly affecting patient outcomes.

Question 4

What is the Mechanism of USP Chapter 797?

Accepted Answer

The chapter specifies controls across multiple operational aspects, including personnel training, facility design, environmental monitoring, equipment sterilization, and aseptic technique. It mandates specific air quality standards, dictates cleaning procedures, and requires personnel to demonstrate proficiency in sterile compounding. These systematic controls collectively reduce the introduction of microorganisms and particulate matter into sterile products.

Question 5

What is the Application of USP Chapter 797?

Accepted Answer

USP Chapter 797 is applied rigorously in hospital pharmacies, specialized compounding pharmacies, and other clinical sites that prepare sterile drugs, including bio-identical hormone preparations for individualized patient needs. Pharmacists and pharmacy technicians are required to follow these guidelines meticulously for all sterile compounding activities. Consistent application of these standards helps assure the safety and efficacy of prepared medications.

Question 6

What is the Metric of USP Chapter 797?

Accepted Answer

Compliance with USP Chapter 797 is assessed through various monitoring activities, including environmental sampling for microbial contamination, routine certification of sterile compounding areas, and media-fill tests to evaluate personnel aseptic technique. Furthermore, sterility testing of finished compounded products and regular audits by regulatory bodies serve as key metrics. These evaluations verify ongoing adherence to established safety protocols.

Question 7

What is the Risk of USP Chapter 797?

Accepted Answer

Failure to comply with USP Chapter 797 standards carries substantial clinical risks, including patient infections, pyrogenic reactions, and other serious adverse events due to contaminated or improperly prepared sterile products. Such non-adherence can lead to suboptimal therapeutic effects, patient harm, and potentially fatal outcomes. For healthcare providers, it also presents significant regulatory penalties and legal liabilities.

USP Chapter 797

Meaning

Context

Significance

Mechanism

Application

Metric

Risk

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