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

Non-sterile topical preparations

Answer

Hazardous drug handling only

Answer

Oral solid dosage form compounding

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 manufacturer's expiration date printed on the original drug container

Answer

The date by which a compounding order must be submitted

Answer

The date a bulk drug substance certificate expires

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

ISO Class 4

Answer

ISO Class 7

Answer

ISO Class 8

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

To protect the compounder from chemical exposure

Answer

To comply with OSHA temperature regulations

Answer

To prevent static electricity from damaging the LAFW

Question 5

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

Accepted Answer

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

Answer

Sterile preparations for injection

Answer

Radiopharmaceutical compounding

Answer

Veterinary sterile injections only

Question 6

When compounding hazardous drugs (HDs), which type of primary engineering control is required?

Accepted Answer

Biological safety cabinet (BSC) Class II Type A2 or C-PEC

Answer

Horizontal laminar airflow workbench (LAFW)

Answer

Positive pressure cleanroom

Answer

Standard pharmacy compounding hood

USP Chapter primarily governs which type of compounding?