1. When compounding sterile preparations, how often should the
air quality in an ISO 5 environment be monitored?
A. Daily
B. Weekly
C. Monthly
D. Annually
Answer: A) Daily
Rationale: Air quality in an ISO 5 environment should be
monitored at least daily to ensure it meets required standards for
particulate and microbial contamination.
2. Which of the following is the most appropriate action when a
sterile compounding area is found to be non-compliant during an
inspection?
A. Immediately halt all compounding activities until compliance is
restored
B. Report the findings to management and continue compounding
activities
C. Continue compounding activities, ensuring no further non-
compliance occurs
D. Call for a reschedule of the inspection
,Answer: A) Immediately halt all compounding activities until
compliance is restored
Rationale: Non-compliance with standards jeopardizes patient
safety, and compounding activities must be halted until the issue
is corrected to ensure sterility and safety.
3. 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.
4. In which of the following scenarios would a pharmacist need to
prepare a compounded sterile preparation in a cleanroom
environment?
A. When preparing an injectable medication
, B. When preparing oral suspensions
C. When preparing a tablet formulation
D. When preparing topical preparations
Answer: A) When preparing an injectable medication
Rationale: Injectable medications are considered sterile
preparations and must be compounded in a cleanroom
environment to maintain sterility.
5. Which of the following is a potential risk associated with
improper garbing before sterile compounding?
A. Increased contamination in the preparation area
B. Faster drug preparation
C. Decreased equipment maintenance costs
D. Improved drug solubility
Answer: A) Increased contamination in the preparation area
Rationale: Improper garbing can lead to the introduction of
contaminants into the sterile compounding environment,
increasing the risk of microbial or particulate contamination.
6. Which of the following should be performed after the
completion of compounding a sterile preparation?
A. The compounded preparation should be labeled with the
compounding date
air quality in an ISO 5 environment be monitored?
A. Daily
B. Weekly
C. Monthly
D. Annually
Answer: A) Daily
Rationale: Air quality in an ISO 5 environment should be
monitored at least daily to ensure it meets required standards for
particulate and microbial contamination.
2. Which of the following is the most appropriate action when a
sterile compounding area is found to be non-compliant during an
inspection?
A. Immediately halt all compounding activities until compliance is
restored
B. Report the findings to management and continue compounding
activities
C. Continue compounding activities, ensuring no further non-
compliance occurs
D. Call for a reschedule of the inspection
,Answer: A) Immediately halt all compounding activities until
compliance is restored
Rationale: Non-compliance with standards jeopardizes patient
safety, and compounding activities must be halted until the issue
is corrected to ensure sterility and safety.
3. 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.
4. In which of the following scenarios would a pharmacist need to
prepare a compounded sterile preparation in a cleanroom
environment?
A. When preparing an injectable medication
, B. When preparing oral suspensions
C. When preparing a tablet formulation
D. When preparing topical preparations
Answer: A) When preparing an injectable medication
Rationale: Injectable medications are considered sterile
preparations and must be compounded in a cleanroom
environment to maintain sterility.
5. Which of the following is a potential risk associated with
improper garbing before sterile compounding?
A. Increased contamination in the preparation area
B. Faster drug preparation
C. Decreased equipment maintenance costs
D. Improved drug solubility
Answer: A) Increased contamination in the preparation area
Rationale: Improper garbing can lead to the introduction of
contaminants into the sterile compounding environment,
increasing the risk of microbial or particulate contamination.
6. Which of the following should be performed after the
completion of compounding a sterile preparation?
A. The compounded preparation should be labeled with the
compounding date
