1. Which of the following items is most likely to introduce
contamination during sterile compounding?
A. Using a non-sterile object to move sterile items
B. Using a sterile syringe for withdrawal
C. Using a clean pair of gloves for handling sterile items
D. Using sterile filters during preparation
Answer: A) Using a non-sterile object to move sterile items
Rationale: Using non-sterile objects to handle or move sterile
items can introduce contaminants, compromising the sterility of
the preparation.
2. Which of the following is the correct definition of "medium-
risk" compounding according to USP <797>?
A. Compounding with non-sterile ingredients in a sterile
environment
B. Compounding using only sterile ingredients
C. Compounding preparations that are complex and involve
multiple sterile ingredients or processes
D. Compounding in a non-sterile environment
Answer: C) Compounding preparations that are complex and
involve multiple sterile ingredients or processes
,Rationale: Medium-risk compounding involves more complex
procedures, such as mixing multiple sterile ingredients or
handling more complicated compounding processes.
3. How should a pharmacist address a situation where a
compounded sterile preparation (CSP) has an incorrect label or is
missing necessary information?
A. Ignore the issue and dispense the preparation
B. Discard the preparation and prepare a new one with correct
labeling
C. Ask the patient to fill out the missing information
D. Submit the preparation to testing
Answer: B) Discard the preparation and prepare a new one with
correct labeling
Rationale: Proper labeling is essential for patient safety, and any
CSP with incorrect or missing labeling should be discarded and
re-prepared with the correct information.
4. Which of the following is NOT a required characteristic of a
sterile compounding area according to USP <797>?
A. Positive air pressure
B. Smooth, non-porous surfaces
C. Room temperature above 25°C
D. Separate hand-washing facilities
, Answer: C) Room temperature above 25°C
Rationale: USP <797> requires that the compounding area
maintain positive air pressure and smooth, non-porous surfaces.
However, the room temperature should ideally be controlled and
not necessarily above 25°C.
5. Which type of equipment is typically used for the sterilization
of compounded sterile preparations?
A. A biological safety cabinet (BSC)
B. A microwave oven
C. An autoclave
D. A UV light chamber
Answer: C) An autoclave
Rationale: An autoclave is commonly used to sterilize
compounded sterile preparations by using steam under pressure to
kill microorganisms.
6. According to USP <797>, what should be done if there is a loss
of air pressure in a sterile compounding area?
A. Continue compounding as usual
B. Shut down compounding operations and investigate the issue
C. Increase air flow in the area
D. Open the windows to allow fresh air circulation
contamination during sterile compounding?
A. Using a non-sterile object to move sterile items
B. Using a sterile syringe for withdrawal
C. Using a clean pair of gloves for handling sterile items
D. Using sterile filters during preparation
Answer: A) Using a non-sterile object to move sterile items
Rationale: Using non-sterile objects to handle or move sterile
items can introduce contaminants, compromising the sterility of
the preparation.
2. Which of the following is the correct definition of "medium-
risk" compounding according to USP <797>?
A. Compounding with non-sterile ingredients in a sterile
environment
B. Compounding using only sterile ingredients
C. Compounding preparations that are complex and involve
multiple sterile ingredients or processes
D. Compounding in a non-sterile environment
Answer: C) Compounding preparations that are complex and
involve multiple sterile ingredients or processes
,Rationale: Medium-risk compounding involves more complex
procedures, such as mixing multiple sterile ingredients or
handling more complicated compounding processes.
3. How should a pharmacist address a situation where a
compounded sterile preparation (CSP) has an incorrect label or is
missing necessary information?
A. Ignore the issue and dispense the preparation
B. Discard the preparation and prepare a new one with correct
labeling
C. Ask the patient to fill out the missing information
D. Submit the preparation to testing
Answer: B) Discard the preparation and prepare a new one with
correct labeling
Rationale: Proper labeling is essential for patient safety, and any
CSP with incorrect or missing labeling should be discarded and
re-prepared with the correct information.
4. Which of the following is NOT a required characteristic of a
sterile compounding area according to USP <797>?
A. Positive air pressure
B. Smooth, non-porous surfaces
C. Room temperature above 25°C
D. Separate hand-washing facilities
, Answer: C) Room temperature above 25°C
Rationale: USP <797> requires that the compounding area
maintain positive air pressure and smooth, non-porous surfaces.
However, the room temperature should ideally be controlled and
not necessarily above 25°C.
5. Which type of equipment is typically used for the sterilization
of compounded sterile preparations?
A. A biological safety cabinet (BSC)
B. A microwave oven
C. An autoclave
D. A UV light chamber
Answer: C) An autoclave
Rationale: An autoclave is commonly used to sterilize
compounded sterile preparations by using steam under pressure to
kill microorganisms.
6. According to USP <797>, what should be done if there is a loss
of air pressure in a sterile compounding area?
A. Continue compounding as usual
B. Shut down compounding operations and investigate the issue
C. Increase air flow in the area
D. Open the windows to allow fresh air circulation
