ExCPT Sterile and Non-Sterile Compounding Questions and Answers

Question 1

A pharmacy technician is preparing a non-aqueous topical cream by mixing two commercially available ointments. According to USP Chapter <795>, what is the maximum beyond-use date (BUD) that can be assigned to this compounded preparation when stored at room temperature?

Accepted Answer

6 months

Answer

According to USP Chapter <795> guidelines for non-sterile compounding, the default BUD for non-aqueous formulations (like ointments and creams made from commercial products) is the earliest expiration date of any active pharmaceutical ingredient (API) or 6 months, whichever is earlier.

Question 2

When compounding a sterile preparation, which of the following actions is performed first in the garbing process before entering the cleanroom's buffer area?

Accepted Answer

Putting on a hair cover and face mask

Answer

The correct garbing sequence, from dirtiest to cleanest, requires applying shoe covers, then a hair cover, beard cover (if applicable), and a face mask before proceeding to hand hygiene and donning a gown. This minimizes contamination of cleaner items.

Question 3

A technician is compounding a hazardous drug (HD) intravenously. Which type of Primary Engineering Control (PEC) is required to ensure both product sterility and personnel safety?

Accepted Answer

Class II Biological Safety Cabinet (BSC)

Answer

A Class II Biological Safety Cabinet (BSC) is required for compounding sterile hazardous drugs. It provides a sterile environment for the product while using negative pressure and HEPA-filtered exhaust to protect the compounder and the environment from exposure to the hazardous drug.

Question 4

What is the primary purpose of using a filter needle when withdrawing medication from a glass ampule?

Accepted Answer

To prevent glass particles from being introduced into the final preparation

Answer

When a glass ampule is broken, microscopic glass shards can fall into the solution. A filter needle is specifically designed to trap these particles as the medication is withdrawn, ensuring the final sterile product is free from glass contamination.

Question 5

A pharmacy technician is preparing a magic mouthwash that contains several liquid ingredients. Which piece of equipment is most appropriate for accurately measuring 25 mL of a low-viscosity liquid for this non-sterile compound?

Accepted Answer

A graduated cylinder

Answer

For measuring liquids in non-sterile compounding, a graduated cylinder provides greater accuracy than a conical graduate or a beaker. An oral syringe is also accurate but is typically used for smaller volumes or for direct administration. A graduated cylinder is the standard tool for this volume.

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ExCPT Sterile and Non-Sterile Compounding Questions and Answers