ExCPT Test Sterile and Non-Sterile Compounding 2

Question 1

USP Chapter <797> primarily governs which type of compounding?

Accepted Answer

Sterile preparations (injections, ophthalmic, IV admixtures)

Answer

USP <797> establishes standards for compounding sterile preparations (CSPs) to prevent microbial contamination, pyrogens, and other harmful substances in parenteral and other sterile products.

Question 2

What is a 'beyond-use date' (BUD) in compounding?

Accepted Answer

The date after which a compounded preparation should not be used

Answer

The BUD is the date/time after which a compounded preparation should not be used, assigned by the pharmacist based on the nature of the preparation, ingredients, and storage conditions per USP standards.

Question 3

Which ISO classification is required for the Primary Engineering Control (PEC — laminar airflow workbench or BSC) used in sterile compounding?

Accepted Answer

ISO Class 5

Answer

USP <797> requires the PEC (the critical work zone inside the LAFW or BSC) to maintain ISO Class 5 air quality — no more than 3,520 particles ≥0.5 µm per cubic meter of air.

Question 4

What is the primary reason for wearing sterile gloves during aseptic technique in sterile compounding?

Accepted Answer

To prevent introduction of microorganisms from skin flora into the preparation

Answer

The primary purpose is to protect the sterile preparation from microbial contamination — human skin harbors microorganisms that could contaminate sterile products and cause serious patient harm.

Question 5

USP Chapter <795> governs which type of pharmaceutical compounding?

Accepted Answer

Non-sterile preparations (creams, ointments, oral liquids, capsules)

Answer

USP <795> provides standards for non-sterile compounded preparations including topicals (creams, ointments, gels), oral preparations (solutions, suspensions, capsules), and other non-sterile dosage forms.

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ExCPT Test Sterile and Non-Sterile Compounding 2