BCSCP 2026 Study Guide: Sterile Compounding
Pharmacist Certification Practice Questions
Answer Explanations & USP Standards, Quality
Control, Aseptic Technique & Preparation Exam
Preparation
Section 1: Standards, Regulations, and Best Practices (Questions 1–15)
Question 1: A pharmacist is preparing a compounded sterile preparation (CSP)
that uses non-sterile ingredients before terminal sterilization. According to USP
Chapter <797>, this preparation is classified as which category?
A. Category 1
B. Category 2
C. Category 3
D. Immediate-use CSP
Rationale: Category 3 CSPs are those that may be assigned longer beyond-use
dates (BUDs) than the limits for Category 1 or Category 2 CSPs, up to 180 days, if
additional requirements are met. These preparations are compounded in the most
controlled environments and require rigorous sterility assurance testing. A high-
risk level CSP (the predecessor term in the 2008 version) uses non-sterile
ingredients or a non-sterile device at some point before terminal sterilization.
Question 2: Which federal agency publishes the list of hazardous drugs that must
be handled according to USP Chapter <800> standards?
A. FDA
B. NIOSH
C. DEA
D. CDC
Rationale: The National Institute for Occupational Safety and Health (NIOSH)
publishes the "NIOSH List of Antineoplastic and Other Hazardous Drugs in
Healthcare Settings." USP <800> incorporates this list and requires facilities to
create and maintain their own hazardous drug list based on the NIOSH criteria,
,which include carcinogenicity, teratogenicity, reproductive toxicity, organ toxicity
at low doses, and genotoxicity.
Question 3: According to USP Chapter <797>, what is the minimum air quality
required for a primary engineering control (PEC) such as a laminar airflow
workbench?
A. ISO Class 7
B. ISO Class 5
C. ISO Class 8
D. ISO Class 4
Rationale: USP <797> mandates that the air within the PEC, where critical
manipulations occur, must meet or exceed ISO Class 5 standards, which allows for
no more than 3,520 particles per cubic meter of air. This is the critical zone where
the sterile preparation is exposed and must be maintained at the highest level of
cleanliness.
Question 4: Under USP Chapter <797> (2023), how often must aseptic
manipulation competency (including media-fill testing) be performed for personnel
who compound Category 3 CSPs?
A. Annually
B. Every 6 months
C. Every 3 months
D. Every 2 years
Rationale: The revised USP <797> (2023) requires that aseptic manipulation
competency, including media-fill testing, must occur every 6 months for Category
1 and 2 CSPs and every 3 months for Category 3 CSPs. This increased frequency
for Category 3 reflects the higher risk associated with these preparations and the
need for sustained competency.
Question 5: Which of the following is a required element of a facility's quality
assurance and quality control program under USP <797>?
A. Environmental monitoring of air and surfaces
B. Annual employee satisfaction surveys
C. Monthly financial audits
D. Weekly inventory counts
,Rationale: USP <797> requires a comprehensive quality assurance (QA) and
quality control (QC) program that includes environmental monitoring of air and
surfaces in sterile compounding environments, sterility testing when required, end-
product testing, and documentation of all compounding activities.
Question 6: A pharmacist is developing a standard operating procedure (SOP) for
sterile compounding. Which of the following must be included in the SOP
according to USP <797>?
A. Personnel training and competency assessment procedures
B. Marketing strategies for compounded products
C. Competitor pricing analysis
D. Patient satisfaction survey results
Rationale: USP <797> requires SOPs to cover all aspects of sterile compounding,
including personnel training and competency assessment, garbing procedures,
environmental monitoring, cleaning and disinfection, equipment maintenance, and
documentation. SOPs must be reviewed at least annually and whenever there are
changes in procedures or regulations.
Question 7: According to USP <800>, which of the following is required for the
storage of hazardous drugs?
A. Storage in a designated area with negative pressure relative to surrounding
areas
B. Storage in a positive-pressure area
C. Storage in the general pharmacy stock
D. Storage in a patient care area
Rationale: USP <800> requires that hazardous drugs be stored in a designated
area that is externally ventilated, has negative pressure relative to surrounding
areas, and is at least 0.01 inches of water column negative pressure. This
containment strategy prevents the escape of hazardous drug particles into the
surrounding environment.
Question 8: Which of the following is a criterion used by NIOSH to identify a
drug as hazardous?
A. Carcinogenicity
B. Low cost
, C. Wide therapeutic index
D. Oral administration only
Rationale: NIOSH identifies hazardous drugs based on one or more of the
following criteria: carcinogenicity, teratogenicity or other developmental toxicity,
reproductive toxicity, organ toxicity at low doses, genotoxicity, and
structure/toxicity profiles of known hazardous drugs. Cost, therapeutic index, and
route of administration are not criteria for hazard classification.
Question 9: Under USP <797>, what is the maximum beyond-use date (BUD) for
a Category 1 CSP stored at controlled room temperature?
A. 24 hours
B. 12 hours
C. 48 hours
D. 30 days
Rationale: Category 1 CSPs are compounded under the least controlled
environmental conditions and are assigned a BUD of 12 hours or less at controlled
room temperature or 24 hours or less when refrigerated. These BUDs are more
restrictive than those for Category 2 or Category 3 CSPs.
Question 10: Which organization publishes the USP chapters that govern sterile
compounding?
A. FDA
B. ASHP
C. United States Pharmacopeia (USP)
D. The Joint Commission
Rationale: The United States Pharmacopeia (USP) publishes the General Chapters
that set the minimum practice and quality standards for compounding sterile
preparations. USP <797> governs sterile compounding, and USP <800> governs
hazardous drug handling. These chapters are enforceable by state boards of
pharmacy and regulatory agencies.
Question 11: A pharmacist is reviewing the facility's environmental monitoring
program. According to USP <797>, how often must viable air sampling be
performed in a Category 2 buffer room?
A. Daily
B. Weekly
Pharmacist Certification Practice Questions
Answer Explanations & USP Standards, Quality
Control, Aseptic Technique & Preparation Exam
Preparation
Section 1: Standards, Regulations, and Best Practices (Questions 1–15)
Question 1: A pharmacist is preparing a compounded sterile preparation (CSP)
that uses non-sterile ingredients before terminal sterilization. According to USP
Chapter <797>, this preparation is classified as which category?
A. Category 1
B. Category 2
C. Category 3
D. Immediate-use CSP
Rationale: Category 3 CSPs are those that may be assigned longer beyond-use
dates (BUDs) than the limits for Category 1 or Category 2 CSPs, up to 180 days, if
additional requirements are met. These preparations are compounded in the most
controlled environments and require rigorous sterility assurance testing. A high-
risk level CSP (the predecessor term in the 2008 version) uses non-sterile
ingredients or a non-sterile device at some point before terminal sterilization.
Question 2: Which federal agency publishes the list of hazardous drugs that must
be handled according to USP Chapter <800> standards?
A. FDA
B. NIOSH
C. DEA
D. CDC
Rationale: The National Institute for Occupational Safety and Health (NIOSH)
publishes the "NIOSH List of Antineoplastic and Other Hazardous Drugs in
Healthcare Settings." USP <800> incorporates this list and requires facilities to
create and maintain their own hazardous drug list based on the NIOSH criteria,
,which include carcinogenicity, teratogenicity, reproductive toxicity, organ toxicity
at low doses, and genotoxicity.
Question 3: According to USP Chapter <797>, what is the minimum air quality
required for a primary engineering control (PEC) such as a laminar airflow
workbench?
A. ISO Class 7
B. ISO Class 5
C. ISO Class 8
D. ISO Class 4
Rationale: USP <797> mandates that the air within the PEC, where critical
manipulations occur, must meet or exceed ISO Class 5 standards, which allows for
no more than 3,520 particles per cubic meter of air. This is the critical zone where
the sterile preparation is exposed and must be maintained at the highest level of
cleanliness.
Question 4: Under USP Chapter <797> (2023), how often must aseptic
manipulation competency (including media-fill testing) be performed for personnel
who compound Category 3 CSPs?
A. Annually
B. Every 6 months
C. Every 3 months
D. Every 2 years
Rationale: The revised USP <797> (2023) requires that aseptic manipulation
competency, including media-fill testing, must occur every 6 months for Category
1 and 2 CSPs and every 3 months for Category 3 CSPs. This increased frequency
for Category 3 reflects the higher risk associated with these preparations and the
need for sustained competency.
Question 5: Which of the following is a required element of a facility's quality
assurance and quality control program under USP <797>?
A. Environmental monitoring of air and surfaces
B. Annual employee satisfaction surveys
C. Monthly financial audits
D. Weekly inventory counts
,Rationale: USP <797> requires a comprehensive quality assurance (QA) and
quality control (QC) program that includes environmental monitoring of air and
surfaces in sterile compounding environments, sterility testing when required, end-
product testing, and documentation of all compounding activities.
Question 6: A pharmacist is developing a standard operating procedure (SOP) for
sterile compounding. Which of the following must be included in the SOP
according to USP <797>?
A. Personnel training and competency assessment procedures
B. Marketing strategies for compounded products
C. Competitor pricing analysis
D. Patient satisfaction survey results
Rationale: USP <797> requires SOPs to cover all aspects of sterile compounding,
including personnel training and competency assessment, garbing procedures,
environmental monitoring, cleaning and disinfection, equipment maintenance, and
documentation. SOPs must be reviewed at least annually and whenever there are
changes in procedures or regulations.
Question 7: According to USP <800>, which of the following is required for the
storage of hazardous drugs?
A. Storage in a designated area with negative pressure relative to surrounding
areas
B. Storage in a positive-pressure area
C. Storage in the general pharmacy stock
D. Storage in a patient care area
Rationale: USP <800> requires that hazardous drugs be stored in a designated
area that is externally ventilated, has negative pressure relative to surrounding
areas, and is at least 0.01 inches of water column negative pressure. This
containment strategy prevents the escape of hazardous drug particles into the
surrounding environment.
Question 8: Which of the following is a criterion used by NIOSH to identify a
drug as hazardous?
A. Carcinogenicity
B. Low cost
, C. Wide therapeutic index
D. Oral administration only
Rationale: NIOSH identifies hazardous drugs based on one or more of the
following criteria: carcinogenicity, teratogenicity or other developmental toxicity,
reproductive toxicity, organ toxicity at low doses, genotoxicity, and
structure/toxicity profiles of known hazardous drugs. Cost, therapeutic index, and
route of administration are not criteria for hazard classification.
Question 9: Under USP <797>, what is the maximum beyond-use date (BUD) for
a Category 1 CSP stored at controlled room temperature?
A. 24 hours
B. 12 hours
C. 48 hours
D. 30 days
Rationale: Category 1 CSPs are compounded under the least controlled
environmental conditions and are assigned a BUD of 12 hours or less at controlled
room temperature or 24 hours or less when refrigerated. These BUDs are more
restrictive than those for Category 2 or Category 3 CSPs.
Question 10: Which organization publishes the USP chapters that govern sterile
compounding?
A. FDA
B. ASHP
C. United States Pharmacopeia (USP)
D. The Joint Commission
Rationale: The United States Pharmacopeia (USP) publishes the General Chapters
that set the minimum practice and quality standards for compounding sterile
preparations. USP <797> governs sterile compounding, and USP <800> governs
hazardous drug handling. These chapters are enforceable by state boards of
pharmacy and regulatory agencies.
Question 11: A pharmacist is reviewing the facility's environmental monitoring
program. According to USP <797>, how often must viable air sampling be
performed in a Category 2 buffer room?
A. Daily
B. Weekly
