STERILE COMPOUNDING
1ST EDITION
CHAPTER NO. 01: INTRODUCTION
1. Which of the following is NOT one of the three main sections of the United States Pharmacopeia?
a. USP 790
b. USP 795
c. USP 797
d. USP 800
ANSWER: a
FEEDBACK: a. Correct. USP 790 is not one of the three main sections of the
United States Pharmacopeia. It was published in 2014, providing
needed clarification on what it means for a parenteral medical
product to be "essentially free" of visible particulate matter.
b. Incorrect. USP 790 is not one of the three main sections of the
United States Pharmacopeia. It was published in 2014, providing
needed clarification on what it means for a parenteral medical
product to be "essentially free" of visible particulate matter.
c. Incorrect. USP 790 is not one of the three main sections of the
United States Pharmacopeia. It was published in 2014, providing
needed clarification on what it means for a parenteral medical
product to be "essentially free" of visible particulate matter.
d. Incorrect. USP 790 is not one of the three main sections of the
United States Pharmacopeia. It was published in 2014, providing
needed clarification on what it means for a parenteral medical
product to be "essentially free" of visible particulate matter.
POINTS: 1
QUESTION TYPE: Multiple Choice
HAS VARIABLES: False
LEARNING OBJECTIVES: 1.1 - Identify the three United States Pharmacopeia (USP) chapters that relate to
the various types of compounding.
KEYWORDS: BLOOM'S LEVEL: Understand
2. How many minimum hours of sterile compounding-specific continuing education must be completed during
the one-year renewal period, per the Pharmacy Technician Certification Board?
a. Fifteen hours
b. Ten hours
c. Five hours
d. Two hours
ANSWER: c
FEEDBACK: a. Incorrect. A minimum of five hours of sterile compounding-
specific continuing education must be completed during the one-
year renewal period, per the Pharmacy Technician Certification
Board.
, b. Incorrect. A minimum of five hours of sterile compounding-
specific continuing education must be completed during the one-
year renewal period, per the Pharmacy Technician Certification
Board.
c. Correct. A minimum of five hours of sterile compounding-specific
continuing education must be completed during the one-year
renewal period, per the Pharmacy Technician Certification Board.
d. Incorrect. A minimum of five hours of sterile compounding-
specific continuing education must be completed during the one-
year renewal period, per the Pharmacy Technician Certification
Board.
POINTS: 1
QUESTION TYPE: Multiple Choice
HAS VARIABLES: False
LEARNING OBJECTIVES: 1.2 - Describe the two different ways in which a Pharmacy Technician
Certification Board (PTCB)-certified pharmacy technician can qualify to become a
Certified Compounded Sterile Preparation Technician (CSPT).
KEYWORDS: BLOOM'S LEVEL: Understand
3. In the history of sterile compounding, when was laminar airflow introduced?
a. Mid-1950s
b. Mid-1960s
c. Late 1970s
d. Late 1980s
ANSWER: b
FEEDBACK: a. Incorrect. For sterile compounding, laminar airflow was
introduced in the mid-1960s. The first known laminar-airflow hood
was used in 1964 in Arkansas as part of an experimental unit-
dose drug distribution system.
b. Correct. For sterile compounding, laminar airflow was introduced
in the mid-1960s. The first known laminar-airflow hood was used
in 1964 in Arkansas as part of an experimental unit-dose drug
distribution system.
c. Incorrect. For sterile compounding, laminar airflow was
introduced in the mid-1960s. The first known laminar-airflow hood
was used in 1964 in Arkansas as part of an experimental unit-
dose drug distribution system.
d. Incorrect. For sterile compounding, laminar airflow was
introduced in the mid-1960s. The first known laminar-airflow hood
was used in 1964 in Arkansas as part of an experimental unit-
dose drug distribution system.
POINTS: 2
QUESTION TYPE: Multiple Choice
HAS VARIABLES: False
LEARNING OBJECTIVES: 1.3 - Identify the hood environments and cleanroom environments that are required
in order for a pharmacy to be USP-compliant in regards to sterile compounding.
KEYWORDS: BLOOM'S LEVEL: Understand
,4. "Immediate use" sterile products must be administered within what time period?
a. Two hours
b. Three hours
c. Four hours
d. Eight hours
ANSWER: c
FEEDBACK: a. Incorrect. Immediate use sterile products must be administered
within four hours. These sterile products are for direct, immediate
administration and must be discarded if administration does not
begin within four hours of preparation.
b. Incorrect. Immediate use sterile products must be administered
within four hours. These sterile products are for direct, immediate
administration and must be discarded if administration does not
begin within four hours of preparation.
c. Correct. Immediate use sterile products must be administered
within four hours. These sterile products are for direct, immediate
administration and must be discarded if administration does not
begin within four hours of preparation.
d. Incorrect. Immediate use sterile products must be administered
within four hours. These sterile products are for direct, immediate
administration and must be discarded if administration does not
begin within four hours of preparation.
POINTS: 2
QUESTION TYPE: Multiple Choice
HAS VARIABLES: False
LEARNING OBJECTIVES: 1.4 - Summarize the three classifications of compounded sterile preparations.
KEYWORDS: BLOOM'S LEVEL: Understand
5. At what room temperature range must sterile products be stored?
a. 35 to 46°F
b. 46 to 56°F
c. 56 to 67°F
d. 68 to 77°F
ANSWER: d
FEEDBACK: a. Incorrect. A room temperature range of 68 to 77°F is used for the
storage of sterile products. This is part of Category 1 and 2
guidelines for the three different classifications of compounded
sterile products.
b. Incorrect. A room temperature range of 68 to 77°F is used for the
storage of sterile products. This is part of Category 1 and 2
guidelines for the three different classifications of compounded
sterile products.
c. Incorrect. A room temperature range of 68 to 77°F is used for the
storage of sterile products. This is part of Category 1 and 2
guidelines for the three different classifications of compounded
sterile products.
, d. Correct. A room temperature range of 68 to 77°F is used for the
storage of sterile products. This is part of Category 1 and 2
guidelines for the three different classifications of compounded
sterile products.
POINTS: 2
QUESTION TYPE: Multiple Choice
HAS VARIABLES: False
LEARNING OBJECTIVES: 1.4 - Summarize the three classifications of compounded sterile preparations.
KEYWORDS: BLOOM'S LEVEL: Understand
6. The most important areas of hospital pharmacy compounding are regulated by which of the following
organizations?
a. Food and Drug Administration
b. Joint Commission on Accreditation of Healthcare Organizations
c. National Institutes of Health
d. Centers for Disease Control and Prevention
ANSWER: a
FEEDBACK: a. Correct. The most important areas of hospital pharmacy compounding are
regulated by the Food and Drug Administration. These areas include poor
compounding practices, lack of sterility assurance, non-patient-specific
compounded drugs that are not for emergency use, routine and large amounts
of non-patient-specific compounded drugs, interstate distribution of large
amounts of the same, and lack of procedures to obtain these same drugs from
outsourcing facilities.
b. Incorrect. The most important areas of hospital pharmacy compounding are
regulated by the Food and Drug Administration. These areas include poor
compounding practices, lack of sterility assurance, non-patient-specific
compounded drugs that are not for emergency use, routine and large amounts
of non-patient-specific compounded drugs, interstate distribution of large
amounts of the same, and lack of procedures to obtain these same drugs from
outsourcing facilities.
c. Incorrect. The most important areas of hospital pharmacy compounding are
regulated by the Food and Drug Administration. These areas include poor
compounding practices, lack of sterility assurance, non-patient-specific
compounded drugs that are not for emergency use, routine and large amounts
of non-patient-specific compounded drugs, interstate distribution of large
amounts of the same, and lack of procedures to obtain these same drugs from
outsourcing facilities.
d. Incorrect. The most important areas of hospital pharmacy compounding are
regulated by the Food and Drug Administration. These areas include poor
compounding practices, lack of sterility assurance, non-patient-specific
compounded drugs that are not for emergency use, routine and large amounts
of non-patient-specific compounded drugs, interstate distribution of large
amounts of the same, and lack of procedures to obtain these same drugs from
outsourcing facilities.