Question 1

What USP chapter governs the standards for sterile compounding in pharmacy practice?

Accepted Answer

USP <797> sets the standards for sterile compounding, including facility design, personnel training, and beyond-use dating to ensure patient safety.

Question 2

Under USP <797>, what are the three categories of compounded sterile preparations (CSPs) based on risk of microbial contamination?

Accepted Answer

The three categories are Category 1 (shorter BUD, no sterility testing required) and Category 2 (longer BUD, sterility and endotoxin testing required), with the 2023 revision replacing the old low/medium/high risk levels.

Question 3

What is the beyond-use date (BUD) for a Category 1 CSP stored at controlled room temperature?

Accepted Answer

A Category 1 CSP stored at controlled room temperature has a BUD of no more than 12 hours.

Question 4

What is the maximum BUD for a Category 1 CSP stored under refrigeration?

Accepted Answer

A Category 1 CSP stored under refrigeration has a BUD of no more than 24 hours.

Question 5

What is the maximum beyond-use date for an immediate-use CSP that is not a hazardous drug?

Accepted Answer

An immediate-use CSP must be administered within 4 hours of preparation and is intended for emergency or immediate patient care situations.

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