2026 BCSCP Exam Prep: Sterile Compounding
Pharmacist Practice Questions, Answer
Rationales, Aseptic Technique, Quality
Assurance, USP Compliance & Medication
Safety Study Guide
DOMAIN 1: STANDARDS, REGULATIONS, AND BEST PRACTICES
(Questions 1–15)
Question 1
A compounding pharmacist is reviewing the updated USP <797> standards that
became official on November 1, 2023. Under the revised chapter, compounded
sterile preparations (CSPs) are now categorized into which classification system?
A) Low-risk, medium-risk, and high-risk levels
B) Category 1, Category 2, and Category 3 CSPs
C) Immediate-use, short-term, and long-term CSPs
D) Sterile, non-sterile, and hazardous CSPs
Rationale: The revised USP <797> chapter changed the categorization of
compounded sterile preparations (CSPs) from microbial contamination risk levels
(i.e., low-, medium-, and high-risk levels) to Category 1 and Category 2 CSPs.
Category 3 CSPs were added to describe the requirements a compounding facility
must meet at all times for assigning BUDs up to a maximum of 180 days .
Question 2
A compounding pharmacy is preparing to implement USP <800> standards for
hazardous drug handling. According to USP <800>, which organization's list
identifies hazardous drugs that must be handled according to the chapter's
requirements?
A) FDA Orange Book
B) NIOSH hazardous drug list
,C) USP <797> Category 1 list
D) DEA Schedule II list
Rationale: Under USP Chapter <800>, hazardous drugs are identified by their
presence on the National Institute of Occupational Safety and Health (NIOSH)
hazardous drug list. USP <800> provides standards for safe handling of hazardous
drugs to minimize the risk of exposure to healthcare personnel, patients, and the
environment .
Question 3
A pharmacy technician asks the compounding pharmacist about the purpose of
USP <800>. Which statement is MOST accurate?
A) USP <800> establishes beyond-use dates for sterile preparations
B) USP <800> outlines guidelines for safe handling of hazardous drugs,
emphasizing engineering controls, PPE, and compliance with USP <797> and
<795> standards
C) USP <800> replaces USP <797> for all sterile compounding
D) USP <800> applies only to non-sterile compounding
Rationale: USP <800> outlines guidelines for safe handling of hazardous drugs,
emphasizing engineering controls, PPE, and compliance with USP <797> and
<795> standards. It is a section focused on hazardous drug handling and applies to
all healthcare settings where hazardous drugs are handled .
Question 4
A compounding pharmacist is reviewing the intent of USP <797>. According to
the chapter, the intent is to prevent harm, including death, from which five risks?
A) Microbial contamination, excessive bacterial endotoxins, variability in
intended identity, strength or quality, inappropriate packaging, and use of
ingredients of inappropriate quality
B) Drug diversion, medication errors, adverse drug reactions, allergic reactions,
and overdose
C) Contamination, degradation, evaporation, precipitation, and discoloration
D) Infection, toxicity, incompatibility, instability, and insolubility
,Rationale: The intent of USP <797> is to prevent harm, including death, from five
risks: 1) microbial contamination (nonsterility), 2) excessive bacterial endotoxins,
3) variability in the intended identity, strength, or quality of the preparation, 4)
inappropriate packaging, and 5) use of ingredients of inappropriate quality .
Question 5
A compounding pharmacy is determining which beyond-use date (BUD) applies to
a Category 1 CSP stored at controlled room temperature. According to the revised
USP <797>, what is the maximum BUD for a Category 1 CSP without sterility
testing?
A) 12 hours
B) 24 hours
C) 48 hours
D) 7 days
Rationale: Under the revised USP <797>, Category 1 CSPs assigned a BUD
without sterility testing have a maximum BUD of 48 hours at controlled room
temperature, 14 days at controlled cold temperature, and 45 days in the solid frozen
state .
Question 6
A compounding pharmacist is reviewing the requirements for Category 3 CSPs.
What is the maximum BUD that a compounding facility can assign for Category 3
CSPs?
A) 30 days
B) 90 days
C) 180 days
D) 365 days
Rationale: Category 3 CSPs were added to describe the requirements a
compounding facility must meet at all times for assigning BUDs up to a maximum
of 180 days .
, Question 7
A compounding pharmacy is preparing to compound a sterile hazardous drug.
According to USP <800>, which of the following is a required engineering
control?
A) A compounding aseptic containment isolator (CACI) or biological safety
cabinet (BSC) externally vented
B) A laminar airflow workbench in a positive pressure room
C) A cleanroom with positive pressure
D) A non-vented biological safety cabinet
Rationale: USP <800> requires that hazardous drugs be compounded in a CACI
or BSC that is externally vented to prevent exposure to healthcare personnel. The
chapter emphasizes engineering controls, PPE, and compliance with USP <797>
and <795> standards .
Question 8
A compounding pharmacist is reviewing documentation requirements for
compounded sterile preparations. How long must compounding records be
retained?
A) For the same period of time required for any prescription under state law
B) For 1 year
C) For 5 years
D) For 10 years
Rationale: Compounding documentation must include records retained for the
same period of time required for any prescription under state law. Records may be
a copy of the prescription and should include the Master Formulation Record and
Compounding Record .
Question 9
A compounding pharmacy is developing a policy for handling single-dose vials
(SDVs). According to USP <797>, what is the maximum BUD for an SDV that is
punctured in an ISO Class 5 environment?
A) 1 hour
B) 6 hours
Pharmacist Practice Questions, Answer
Rationales, Aseptic Technique, Quality
Assurance, USP Compliance & Medication
Safety Study Guide
DOMAIN 1: STANDARDS, REGULATIONS, AND BEST PRACTICES
(Questions 1–15)
Question 1
A compounding pharmacist is reviewing the updated USP <797> standards that
became official on November 1, 2023. Under the revised chapter, compounded
sterile preparations (CSPs) are now categorized into which classification system?
A) Low-risk, medium-risk, and high-risk levels
B) Category 1, Category 2, and Category 3 CSPs
C) Immediate-use, short-term, and long-term CSPs
D) Sterile, non-sterile, and hazardous CSPs
Rationale: The revised USP <797> chapter changed the categorization of
compounded sterile preparations (CSPs) from microbial contamination risk levels
(i.e., low-, medium-, and high-risk levels) to Category 1 and Category 2 CSPs.
Category 3 CSPs were added to describe the requirements a compounding facility
must meet at all times for assigning BUDs up to a maximum of 180 days .
Question 2
A compounding pharmacy is preparing to implement USP <800> standards for
hazardous drug handling. According to USP <800>, which organization's list
identifies hazardous drugs that must be handled according to the chapter's
requirements?
A) FDA Orange Book
B) NIOSH hazardous drug list
,C) USP <797> Category 1 list
D) DEA Schedule II list
Rationale: Under USP Chapter <800>, hazardous drugs are identified by their
presence on the National Institute of Occupational Safety and Health (NIOSH)
hazardous drug list. USP <800> provides standards for safe handling of hazardous
drugs to minimize the risk of exposure to healthcare personnel, patients, and the
environment .
Question 3
A pharmacy technician asks the compounding pharmacist about the purpose of
USP <800>. Which statement is MOST accurate?
A) USP <800> establishes beyond-use dates for sterile preparations
B) USP <800> outlines guidelines for safe handling of hazardous drugs,
emphasizing engineering controls, PPE, and compliance with USP <797> and
<795> standards
C) USP <800> replaces USP <797> for all sterile compounding
D) USP <800> applies only to non-sterile compounding
Rationale: USP <800> outlines guidelines for safe handling of hazardous drugs,
emphasizing engineering controls, PPE, and compliance with USP <797> and
<795> standards. It is a section focused on hazardous drug handling and applies to
all healthcare settings where hazardous drugs are handled .
Question 4
A compounding pharmacist is reviewing the intent of USP <797>. According to
the chapter, the intent is to prevent harm, including death, from which five risks?
A) Microbial contamination, excessive bacterial endotoxins, variability in
intended identity, strength or quality, inappropriate packaging, and use of
ingredients of inappropriate quality
B) Drug diversion, medication errors, adverse drug reactions, allergic reactions,
and overdose
C) Contamination, degradation, evaporation, precipitation, and discoloration
D) Infection, toxicity, incompatibility, instability, and insolubility
,Rationale: The intent of USP <797> is to prevent harm, including death, from five
risks: 1) microbial contamination (nonsterility), 2) excessive bacterial endotoxins,
3) variability in the intended identity, strength, or quality of the preparation, 4)
inappropriate packaging, and 5) use of ingredients of inappropriate quality .
Question 5
A compounding pharmacy is determining which beyond-use date (BUD) applies to
a Category 1 CSP stored at controlled room temperature. According to the revised
USP <797>, what is the maximum BUD for a Category 1 CSP without sterility
testing?
A) 12 hours
B) 24 hours
C) 48 hours
D) 7 days
Rationale: Under the revised USP <797>, Category 1 CSPs assigned a BUD
without sterility testing have a maximum BUD of 48 hours at controlled room
temperature, 14 days at controlled cold temperature, and 45 days in the solid frozen
state .
Question 6
A compounding pharmacist is reviewing the requirements for Category 3 CSPs.
What is the maximum BUD that a compounding facility can assign for Category 3
CSPs?
A) 30 days
B) 90 days
C) 180 days
D) 365 days
Rationale: Category 3 CSPs were added to describe the requirements a
compounding facility must meet at all times for assigning BUDs up to a maximum
of 180 days .
, Question 7
A compounding pharmacy is preparing to compound a sterile hazardous drug.
According to USP <800>, which of the following is a required engineering
control?
A) A compounding aseptic containment isolator (CACI) or biological safety
cabinet (BSC) externally vented
B) A laminar airflow workbench in a positive pressure room
C) A cleanroom with positive pressure
D) A non-vented biological safety cabinet
Rationale: USP <800> requires that hazardous drugs be compounded in a CACI
or BSC that is externally vented to prevent exposure to healthcare personnel. The
chapter emphasizes engineering controls, PPE, and compliance with USP <797>
and <795> standards .
Question 8
A compounding pharmacist is reviewing documentation requirements for
compounded sterile preparations. How long must compounding records be
retained?
A) For the same period of time required for any prescription under state law
B) For 1 year
C) For 5 years
D) For 10 years
Rationale: Compounding documentation must include records retained for the
same period of time required for any prescription under state law. Records may be
a copy of the prescription and should include the Master Formulation Record and
Compounding Record .
Question 9
A compounding pharmacy is developing a policy for handling single-dose vials
(SDVs). According to USP <797>, what is the maximum BUD for an SDV that is
punctured in an ISO Class 5 environment?
A) 1 hour
B) 6 hours
