Hazardous Drug Management Pharmacy Technician
Certification 2026 Latest Study Guide with Practice
Questions, Safe Handling Review, Verified Answers,
Detailed Rationales, Success Workbook
QUESTION 1
Under USP General Chapter <800>, what is the official title of the chapter?
A) Pharmaceutical Compounding — Sterile Preparations
B) Hazardous Drugs — Handling in Healthcare Settings
C) Pharmaceutical Compounding — Nonsterile Preparations
D) Hazardous Waste Handling in Pharmacies
Answer: B) Hazardous Drugs — Handling in Healthcare Settings
Rationale: USP General Chapter <800> is officially titled "Hazardous Drugs —
Handling in Healthcare Settings." It describes practice and quality standards for
handling hazardous drugs to promote patient safety, worker safety, and
environmental protection. USP <797> governs sterile compounding, and USP
<795> governs nonsterile compounding.
QUESTION 2
Which federal agency publishes the List of Hazardous Drugs in Healthcare
Settings that USP <800> references?
A) FDA (Food and Drug Administration)
B) OSHA (Occupational Safety and Health Administration)
C) NIOSH (National Institute for Occupational Safety and Health)
D) DEA (Drug Enforcement Administration)
Answer: C) NIOSH (National Institute for Occupational Safety and Health)
Rationale: NIOSH, a part of the CDC, publishes the List of Hazardous Drugs in
Healthcare Settings. USP <800> requires entities that handle hazardous drugs to
maintain a list that includes, at minimum, the drugs on the current NIOSH list.
OSHA provides worker exposure guidance but does not maintain the HD list.
,QUESTION 3
What is the minimum passing scaled score for the PTCB Hazardous Drug
Management Certificate exam?
A) 250/400
B) 300/400
C) 350/400
D) 400/400
Answer: B) 300/400
Rationale: The PTCB Hazardous Drug Management Certificate exam requires a
scaled score of 300 out of 400 to pass. The exam consists of 55 multiple-choice
questions with an 80-minute time limit.
QUESTION 4
Under USP <800>, who is responsible for the overall hazardous drug handling
program at a facility?
A) The pharmacist-in-charge only
B) Any certified pharmacy technician
C) The Designated Person
D) The facility's CEO
Answer: C) The Designated Person
Rationale: USP <800> requires that one or more Designated Persons be assigned
responsibility and authority for the hazardous drug handling program, including
SOPs, training, and compliance oversight.
QUESTION 5
What type of engineering control must be used for sterile hazardous drug
compounding?
A) Horizontal laminar airflow workbench
B) Class II Biological Safety Cabinet (BSC) or Compounding Aseptic
,Containment Isolator (CACI)
C) Unventilated laminar flow hood
D) Conventional fume hood
Answer: B) Class II Biological Safety Cabinet (BSC) or Compounding Aseptic
Containment Isolator (CACI)
Rationale: For sterile hazardous compounding, the Containment Primary
Engineering Control (C-PEC) must be a Class II Biological Safety Cabinet (BSC)
or a Compounding Aseptic Containment Isolator (CACI). These devices provide
ISO Class 5 air quality to protect the sterile product while simultaneously using
specialized airflow design and HEPA filters to protect the worker from drug
exposure.
QUESTION 6
How must the exhaust air from a C-PEC used for hazardous drug compounding be
vented?
A) Recirculated into the cleanroom
B) Recirculated into the pharmacy department
C) Externally vented to the outside of the building
D) Vented into the anteroom
Answer: C) Externally vented to the outside of the building
Rationale: The C-PEC must run continuously (24/7) and must be externally
vented, meaning the exhausted air is sent directly outside the building, never
recirculated into the pharmacy.
QUESTION 7
What is the minimum number of air changes per hour (ACPH) required for a room
used to compound sterile hazardous drugs (C-SEC)?
A) 12 ACPH
B) 15 ACPH
C) 30 ACPH
D) 60 ACPH
, Answer: C) 30 ACPH
Rationale: For a room used to compound sterile hazardous drugs, the Containment
Secondary Engineering Control (C-SEC) must maintain a minimum of 30 air
changes per hour.
QUESTION 8
What is the minimum number of air changes per hour required for a room used
solely for storing hazardous drugs or compounding non-sterile hazardous drugs?
A) 12 ACPH
B) 15 ACPH
C) 30 ACPH
D) 60 ACPH
Answer: A) 12 ACPH
Rationale: If the room is used solely for storing hazardous drugs or compounding
non-sterile hazardous drugs, it must maintain a minimum of 12 ACPH.
QUESTION 9
What type of PPE is mandatory when handling hazardous drugs under USP
<800>?
A) Single chemotherapy gloves and cloth gown
B) Double chemotherapy gloves and impermeable gown
C) Single latex gloves and plastic apron
D) No PPE required for low-risk drugs
Answer: B) Double chemotherapy gloves and impermeable gown
Rationale: Appropriate Personal Protective Equipment (PPE), including double
chemotherapy gloves and impermeable gowns, is mandatory when handling
hazardous drugs.
QUESTION 10
Certification 2026 Latest Study Guide with Practice
Questions, Safe Handling Review, Verified Answers,
Detailed Rationales, Success Workbook
QUESTION 1
Under USP General Chapter <800>, what is the official title of the chapter?
A) Pharmaceutical Compounding — Sterile Preparations
B) Hazardous Drugs — Handling in Healthcare Settings
C) Pharmaceutical Compounding — Nonsterile Preparations
D) Hazardous Waste Handling in Pharmacies
Answer: B) Hazardous Drugs — Handling in Healthcare Settings
Rationale: USP General Chapter <800> is officially titled "Hazardous Drugs —
Handling in Healthcare Settings." It describes practice and quality standards for
handling hazardous drugs to promote patient safety, worker safety, and
environmental protection. USP <797> governs sterile compounding, and USP
<795> governs nonsterile compounding.
QUESTION 2
Which federal agency publishes the List of Hazardous Drugs in Healthcare
Settings that USP <800> references?
A) FDA (Food and Drug Administration)
B) OSHA (Occupational Safety and Health Administration)
C) NIOSH (National Institute for Occupational Safety and Health)
D) DEA (Drug Enforcement Administration)
Answer: C) NIOSH (National Institute for Occupational Safety and Health)
Rationale: NIOSH, a part of the CDC, publishes the List of Hazardous Drugs in
Healthcare Settings. USP <800> requires entities that handle hazardous drugs to
maintain a list that includes, at minimum, the drugs on the current NIOSH list.
OSHA provides worker exposure guidance but does not maintain the HD list.
,QUESTION 3
What is the minimum passing scaled score for the PTCB Hazardous Drug
Management Certificate exam?
A) 250/400
B) 300/400
C) 350/400
D) 400/400
Answer: B) 300/400
Rationale: The PTCB Hazardous Drug Management Certificate exam requires a
scaled score of 300 out of 400 to pass. The exam consists of 55 multiple-choice
questions with an 80-minute time limit.
QUESTION 4
Under USP <800>, who is responsible for the overall hazardous drug handling
program at a facility?
A) The pharmacist-in-charge only
B) Any certified pharmacy technician
C) The Designated Person
D) The facility's CEO
Answer: C) The Designated Person
Rationale: USP <800> requires that one or more Designated Persons be assigned
responsibility and authority for the hazardous drug handling program, including
SOPs, training, and compliance oversight.
QUESTION 5
What type of engineering control must be used for sterile hazardous drug
compounding?
A) Horizontal laminar airflow workbench
B) Class II Biological Safety Cabinet (BSC) or Compounding Aseptic
,Containment Isolator (CACI)
C) Unventilated laminar flow hood
D) Conventional fume hood
Answer: B) Class II Biological Safety Cabinet (BSC) or Compounding Aseptic
Containment Isolator (CACI)
Rationale: For sterile hazardous compounding, the Containment Primary
Engineering Control (C-PEC) must be a Class II Biological Safety Cabinet (BSC)
or a Compounding Aseptic Containment Isolator (CACI). These devices provide
ISO Class 5 air quality to protect the sterile product while simultaneously using
specialized airflow design and HEPA filters to protect the worker from drug
exposure.
QUESTION 6
How must the exhaust air from a C-PEC used for hazardous drug compounding be
vented?
A) Recirculated into the cleanroom
B) Recirculated into the pharmacy department
C) Externally vented to the outside of the building
D) Vented into the anteroom
Answer: C) Externally vented to the outside of the building
Rationale: The C-PEC must run continuously (24/7) and must be externally
vented, meaning the exhausted air is sent directly outside the building, never
recirculated into the pharmacy.
QUESTION 7
What is the minimum number of air changes per hour (ACPH) required for a room
used to compound sterile hazardous drugs (C-SEC)?
A) 12 ACPH
B) 15 ACPH
C) 30 ACPH
D) 60 ACPH
, Answer: C) 30 ACPH
Rationale: For a room used to compound sterile hazardous drugs, the Containment
Secondary Engineering Control (C-SEC) must maintain a minimum of 30 air
changes per hour.
QUESTION 8
What is the minimum number of air changes per hour required for a room used
solely for storing hazardous drugs or compounding non-sterile hazardous drugs?
A) 12 ACPH
B) 15 ACPH
C) 30 ACPH
D) 60 ACPH
Answer: A) 12 ACPH
Rationale: If the room is used solely for storing hazardous drugs or compounding
non-sterile hazardous drugs, it must maintain a minimum of 12 ACPH.
QUESTION 9
What type of PPE is mandatory when handling hazardous drugs under USP
<800>?
A) Single chemotherapy gloves and cloth gown
B) Double chemotherapy gloves and impermeable gown
C) Single latex gloves and plastic apron
D) No PPE required for low-risk drugs
Answer: B) Double chemotherapy gloves and impermeable gown
Rationale: Appropriate Personal Protective Equipment (PPE), including double
chemotherapy gloves and impermeable gowns, is mandatory when handling
hazardous drugs.
QUESTION 10
