CSPT Certified Compounded Sterile Preparation Technician Exam — Questions and Answers

Question 1: According to USP <797>, what is the maximum beyond-use date (BUD) for a Category 1 compounded sterile preparation (CSP) stored at room temperature?

12 hours (Correct answer)
24 hours
72 hours
48 hours

Correct answer: 12 hours

USP <797> assigns Category 1 CSPs a BUD of 12 hours or less at controlled room temperature.

Question 2: Under a robust QA program, which document formally authorizes the release of a compounded sterile preparation batch for dispensing?

A batch record reviewed and signed by a pharmacist verifying all quality checks were met (Correct answer)
A verbal confirmation from the compounding technician
The packing slip from the ingredient supplier
The original physician prescription

Correct answer: A batch record reviewed and signed by a pharmacist verifying all quality checks were met

Batch release requires a pharmacist to review the completed batch record confirming ingredient identity, quantities, process parameters, and QC test results before the preparation is dispensed.

Question 3: According to USP <797>, once a single-dose vial has been punctured inside an ISO Class 5 environment, for how long may it be used to prepare Compounded Sterile Preparations (CSPs)?

Indefinitely, as long as it remains in the PEC.
Up to 12 hours from the time of initial puncture. (Correct answer)
Up to 24 hours if stored at room temperature.
Up to 1 hour, after which it must be discarded.

Correct answer: Up to 12 hours from the time of initial puncture.

The revised USP Chapter <797> states that a single-dose container that has been entered or punctured inside an ISO Class 5 Primary Engineering Control (PEC) may be used for up to 12 hours after the initial entry, provided it is stored under appropriate conditions. This allows for more efficient use of the component while maintaining microbial safety standards.

Question 4: Which USP chapter establishes standards specifically for hazardous drug handling in healthcare settings?

USP <1>
USP <795>
USP <825>
USP <800> (Correct answer)

Correct answer: USP <800>

USP <800> sets requirements for receiving, storing, compounding, dispensing, and disposing of hazardous drugs to protect healthcare workers and patients.

Question 5: During non-sterile to sterile compounding, a technician notices visible particulate matter in the solution after reconstitution. What is the correct action?

Adjust the pH to improve solubility and continue
Filter the solution through a 5 µm filter and proceed
Increase agitation to dissolve the particulate
Discard the preparation and document the discrepancy (Correct answer)

Correct answer: Discard the preparation and document the discrepancy

Any preparation with visible particulate matter must be discarded, as it fails visual inspection criteria and poses a patient safety risk.

Question 6: What action should be taken if the primary engineering control (PEC) HEPA filter fails certification during routine testing?

Continue compounding using extra PPE as a precaution
Notify the pharmacist but continue low-risk compounding only
Reduce airflow speed to prevent further damage
Immediately cease compounding until the filter is repaired or replaced (Correct answer)

Correct answer: Immediately cease compounding until the filter is repaired or replaced

USP <797> requires that compounding cease immediately when a PEC fails certification, as sterility of preparations can no longer be assured.

Question 7: A CSP label reads 'Vancomycin 1 g/250 mL NS.' A nurse asks what concentration this represents in mg/mL. What is the correct answer?

0.4 mg/mL
400 mg/mL
40 mg/mL
4 mg/mL (Correct answer)

Correct answer: 4 mg/mL

1 g = 1,000 mg divided by 250 mL equals 4 mg/mL.

Question 8: Which of the following best describes a 'dynamic' environmental monitoring condition?

Testing performed after deep cleaning with no personnel present
Testing performed with all equipment powered off
Testing performed immediately after HEPA filter replacement
Testing performed while normal compounding activities are occurring (Correct answer)

Correct answer: Testing performed while normal compounding activities are occurring

Dynamic (in-use) monitoring is conducted while compounding operations are actively taking place with personnel present, which represents the worst-case scenario and provides the most meaningful data.

Question 9: Why must a filter needle be changed to a regular needle after withdrawing from a glass ampule?

Filter needles are too large gauge for IV bags
Filter needles are too expensive to waste
There is no need to change needles
The filter needle may release trapped glass particles if used to inject (Correct answer)

Correct answer: The filter needle may release trapped glass particles if used to inject

Glass particles trapped in the filter could be expelled into the final container if the same needle is used for injection.

Question 10: An ophthalmology clinic requests a CSP eye drop with a 30-day BUD. The preparation uses only sterile commercial products as starting ingredients, and no sterility testing is performed. Under USP <797>, this request is:

Not achievable without sterility testing data supporting the extended BUD (Correct answer)
Acceptable if the preparation is made in an ISO 5 environment
Permissible if a preservative is added
Acceptable under Category 1 defaults

Correct answer: Not achievable without sterility testing data supporting the extended BUD

Without sterility testing or peer-reviewed stability data, a 30-day BUD exceeds Category 2 defaults and cannot be assigned regardless of ISO classification.

Question 11: A biological safety cabinet (BSC) Class II Type A2 used for hazardous drug compounding differs from a standard LAFW primarily because it:

Uses UV light instead of HEPA filtration for sterilization
Operates under positive pressure to protect the product from room air
Recirculates filtered air internally and exhausts a portion to the outside, protecting both product and operator (Correct answer)
Provides only product protection with no operator protection

Correct answer: Recirculates filtered air internally and exhausts a portion to the outside, protecting both product and operator

A Class II Type A2 BSC recirculates approximately 70% of air through a HEPA filter within the cabinet and exhausts 30% to the outside, providing both product and personnel protection.

Question 12: A compounding technician notes that a completed CSP label shows a BUD that has already passed. What should be done immediately?

Administer the preparation since it was stored properly
Cross out the BUD and write the correct date
Relabel with a new BUD if the preparation appears visually acceptable
Quarantine and do not dispense; notify the pharmacist for proper disposal (Correct answer)

Correct answer: Quarantine and do not dispense; notify the pharmacist for proper disposal

Any CSP past its BUD must be quarantined and not dispensed, regardless of appearance, because stability and sterility can no longer be assured.

Question 13: You prepare 500 mL of a parenteral solution. The label requires a 1:200 concentration of drug. How many grams of drug are in the bag?

5 g
0.25 g
0.5 g
2.5 g (Correct answer)

Correct answer: 2.5 g

1:200 = 1 g per 200 mL; for 500 mL: 500/200 = 2.5 g.

Question 14: How should ingredients be introduced into the PEC to maintain aseptic conditions?

Decontaminate outer surfaces with sterile 70% IPA, remove outer packaging in ante-area, and place items without blocking airflow (Correct answer)
No decontamination needed if commercially sterile
Place items directly from storage shelves
Bring all items in original shipping boxes

Correct answer: Decontaminate outer surfaces with sterile 70% IPA, remove outer packaging in ante-area, and place items without blocking airflow

Components must have outer packaging removed in the ante-area, surfaces wiped with sterile 70% IPA, then placed in the PEC without blocking airflow.

Question 15: A technician notices that a vial of vancomycin powder for injection has turned slightly yellow. What is the appropriate action?

Quarantine the vial and report to the pharmacist (Correct answer)
Return it to the shelf if within expiration date
Use it immediately before further discoloration occurs
Mix it and check final solution color instead

Correct answer: Quarantine the vial and report to the pharmacist

Any visual change in an API or drug product is grounds for quarantine and pharmacist evaluation, as discoloration may indicate degradation.

Question 16: How many milliequivalents of potassium are in 20 mL of potassium chloride 10% (MW KCl = 74.5 g/mol)?

13.4 mEq
53.6 mEq
26.8 mEq (Correct answer)
40 mEq

Correct answer: 26.8 mEq

20 mL × 0.10 g/mL = 2 g; 2000 mg ÷ 74.5 mg/mEq = 26.8 mEq.

Question 17: What is the maximum time a multi-dose vial may be used after initial puncture according to USP 797?

48 hours
28 days unless otherwise specified by the manufacturer (Correct answer)
Indefinitely if stored properly
24 hours

Correct answer: 28 days unless otherwise specified by the manufacturer

Multi-dose vials may be used for up to 28 days after initial puncture unless the manufacturer specifies shorter dating.

Question 18: What is the main objective of quality assurance protocols in sterile compounding?

To ensure that compounded sterile preparations (CSPs) meet specified standards for quality and safety (Correct answer)
To reduce the time required for compounding
To simplify the compounding process
To increase the cost of production

Correct answer: To ensure that compounded sterile preparations (CSPs) meet specified standards for quality and safety

Quality assurance protocols are designed to ensure that CSPs are safe, effective, and of high quality.

Question 19: Under USP <797>, how must environmental monitoring data be trended over time?

Data must be sent to the FDA quarterly
Data must be reviewed monthly and trended to identify patterns before action levels are exceeded (Correct answer)
Data must be reviewed only when an exceedance occurs
Data must be reviewed annually during certification

Correct answer: Data must be reviewed monthly and trended to identify patterns before action levels are exceeded

USP <797> requires routine trending of environmental monitoring data to detect upward trends that may predict future exceedances before action levels are breached.

Question 20: In the garbing sequence, which item should be donned AFTER shoe covers but BEFORE the sterile gown?

Face mask and hair cover (Correct answer)
Sterile gloves
Sleeve covers
Goggles

Correct answer: Face mask and hair cover

The correct garbing order requires putting on a face mask and hair cover after shoe covers and before the sterile gown to minimize particle shedding onto the gown.

Question 21: A technician needs to disinfect the rubber stopper of a vial before piercing it with a needle inside the Primary Engineering Control (PEC). According to USP <797>, which of the following is the most appropriate agent to use?

Sterile water for irrigation
Sterile 70% isopropyl alcohol (Correct answer)
Non-sterile 70% isopropyl alcohol
Sterile 40% isopropyl alcohol

Correct answer: Sterile 70% isopropyl alcohol

USP <797> requires that critical sites, such as vial stoppers, be disinfected by wiping them with sterile 70% isopropyl alcohol (IPA) and allowing it to dry. The use of sterile IPA is critical to prevent the introduction of microbial contamination into the vial. Non-sterile IPA is not appropriate for use on critical sites within the PEC, and other concentrations or agents like sterile water are not the specified standard.

Question 22: Which of the following BEST describes 'terminal sterilization' as opposed to 'aseptic processing'?

Filtering the preparation immediately before it is administered to the patient
Using pre-sterilized disposable equipment to avoid introducing contamination
Sterilizing all individual components before compounding begins
Sterilizing the final sealed container after filling to achieve a defined sterility assurance level (Correct answer)

Correct answer: Sterilizing the final sealed container after filling to achieve a defined sterility assurance level

Terminal sterilization involves sterilizing the product after it has been filled and sealed in its final container (e.g., autoclaving a sealed vial). This is contrasted with aseptic processing, where sterile components are combined under aseptic conditions but the final container is never subjected to a sterilization step.

Question 23: In a non-hazardous sterile compounding cleanroom suite, what is the primary reason for maintaining a positive pressure differential between the buffer area and the ante-area?

To concentrate the effectiveness of cleaning agents
To ensure easier opening and closing of doors
To reduce energy consumption of the HVAC system
To prevent airborne contaminants from entering the cleaner buffer area (Correct answer)

Correct answer: To prevent airborne contaminants from entering the cleaner buffer area

Positive pressure ensures that air flows from cleaner spaces (the buffer area) to less clean spaces (the ante-area). This airflow pattern acts as a barrier, preventing particles and microorganisms from the ante-area from entering the critical buffer area where compounding occurs.

Question 24: A technician is preparing a non-sterile cream by mixing two commercially available ointments. Which USP chapter provides the primary standards for this type of compounding?

USP <795> (Correct answer)
USP <71>
USP <797>
USP <800>

Correct answer: USP <795>

USP General Chapter <795> provides standards for the process of compounding quality nonsterile preparations. USP <797> applies to sterile compounding, USP <800> applies to the handling of hazardous drugs, and USP <71> covers sterility tests.

Question 25: A technician is working with a hazardous drug inside a Compounding Aseptic Containment Isolator (CACI). Which feature is essential for this type of Primary Engineering Control to protect the technician?

Unidirectional vertical airflow only
Positive air pressure relative to the surrounding room
A heated work surface to vaporize spills
Negative air pressure relative to the surrounding room (Correct answer)

Correct answer: Negative air pressure relative to the surrounding room

A Compounding Aseptic Containment Isolator (CACI) is used for hazardous drugs and must maintain negative air pressure. This ensures that in the event of a breach, air from the surrounding room flows into the isolator, preventing hazardous drug particles or vapors from escaping into the cleanroom and protecting the compounder.

Question 26: A compounder adds 20 mEq of KCl and 30 mEq of NaCl to a 1 L TPN. The combined mEq of monovalent electrolytes is:

50 mEq (Correct answer)
100 mEq
20 mEq
30 mEq

Correct answer: 50 mEq

Both KCl and NaCl contribute 1 mEq/mEq of monovalent ions; total = 20 + 30 = 50 mEq.

Question 27: An 80-kg patient needs phenytoin 15 mg/kg in 250 mL of NS. Stock vial is 250 mg/5 mL. What volume should be withdrawn?

12 mL
18 mL
24 mL (Correct answer)
30 mL

Correct answer: 24 mL

Loading dose is 1,200 mg. Stock is 50 mg/mL. Volume is 1,200 divided by 50 equals 24 mL.

Question 28: What is the minimum air changes per hour (ACPH) required for the buffer area under USP 797?

30 ACPH (Correct answer)
50 ACPH
20 ACPH
10 ACPH

Correct answer: 30 ACPH

USP 797 requires a minimum of 30 air changes per hour in the buffer area.

Question 29: Glove fingertip sampling (fingertip testing) is performed to:

Check HEPA filter efficiency
Verify that personnel gloving and gowning technique does not introduce contamination (Correct answer)
Monitor pressure differential between rooms
Test the sterility of compounded end-products

Correct answer: Verify that personnel gloving and gowning technique does not introduce contamination

Fingertip testing checks whether the technician's gloves carry microbial contamination after gowning, confirming that hand hygiene and gloving procedures were effective.

Question 30: When documenting a deviation from the Master Formulation Record, what is required?

The deviation must be documented with reason, approval by designated person, and impact assessment (Correct answer)
No documentation if pharmacist approves verbally
Only a verbal notification to supervisor
Deviations are never permitted

Correct answer: The deviation must be documented with reason, approval by designated person, and impact assessment

Any deviation from the MFR must be formally documented including the nature, reason, approval, and impact assessment.

Question 31: What is the maximum recommended final concentration of dextrose in a peripherally administered IV admixture?

5%
10%
12.5% (Correct answer)
20%

Correct answer: 12.5%

Peripheral parenteral nutrition should not exceed 12.5% dextrose to avoid phlebitis and vein damage.

Question 32: The 'first air' concept in laminar airflow workbenches refers to:

The exhaust air expelled outside the cleanroom
The initial airflow burst when the BLAC is first powered on
Air recirculated from the room into the HEPA filter
Air that has passed through the HEPA filter before contacting any surface or critical site (Correct answer)

Correct answer: Air that has passed through the HEPA filter before contacting any surface or critical site

First air is the unobstructed HEPA-filtered air directly from the filter face, which must reach critical sites without being deflected by objects or hands.

Question 33: According to USP Chapter <797>, which of the following is the minimum ISO classification required for a buffer area where non-hazardous sterile compounding is performed?

ISO Class 5
ISO Class 8
ISO Class 9
ISO Class 7 (Correct answer)

Correct answer: ISO Class 7

USP Chapter <797> mandates that the buffer area, which houses the Primary Engineering Controls (PECs), must maintain at least an ISO Class 7 air quality to minimize the risk of contamination to compounded sterile preparations.

Question 34: The most effective strategy to prevent biofilm formation on cleanroom surfaces is:

Increasing cleanroom ambient temperature above 25°C
Reducing the number of personnel allowed in the room
Regular cleaning and rotation of disinfectants from different chemical classes (Correct answer)
Using a single trusted disinfectant consistently every day

Correct answer: Regular cleaning and rotation of disinfectants from different chemical classes

Rotating disinfectants prevents microorganisms from developing resistance and ensures broad-spectrum coverage against different contaminant types.

Question 35: Upon receiving a new stock of medication vials, what is the FIRST step a technician should perform as part of the component handling process?

Refrigerate the entire shipment immediately.
Visually inspect each vial for particulate matter, cracks, or defects. (Correct answer)
Place the vials directly into the buffer area storage.
Wipe each vial with a sporicidal agent.

Correct answer: Visually inspect each vial for particulate matter, cracks, or defects.

Before any other handling or storage steps, all components must be visually inspected upon receipt to ensure their integrity. This includes checking for cracks, leaks, particulate matter, and verifying that the label is correct and the product is not expired. This initial inspection prevents compromised components from entering the compounding workflow.

Question 36: When disinfecting a laminar airflow workbench (LAFW), in which direction should the technician wipe the work surface?

From front to back in a single continuous motion
In circular motions starting from the center outward
From left to right only, avoiding the HEPA filter
From back to front in overlapping, side-to-side strokes (Correct answer)

Correct answer: From back to front in overlapping, side-to-side strokes

Wiping from back to front using overlapping side-to-side strokes moves contamination away from the HEPA filter toward the operator, preventing recontamination of the clean zone.

Question 37: What are high-alert medications and why do they require special safeguards?

Medications with heightened risk of causing significant patient harm when used in error (Correct answer)
Medications requiring refrigeration
Medications only available by prescription
Medications that are expensive

Correct answer: Medications with heightened risk of causing significant patient harm when used in error

High-alert medications carry disproportionate risk of devastating harm when errors occur.

Question 38: What is the primary purpose of conducting a media-fill test (process simulation) in a sterile compounding facility?

To sterilize the compounding equipment before use.
To determine the chemical stability and beyond-use date of a new formulation.
To verify that the cleanroom's air quality meets its ISO classification.
To qualify a technician's aseptic technique and validate the compounding processes. (Correct answer)

Correct answer: To qualify a technician's aseptic technique and validate the compounding processes.

A media-fill test uses a sterile microbiological growth medium (like Tryptic Soy Broth) in place of actual drug components to simulate the entire compounding process. Its main purpose is to serve as a performance-based test to ensure that personnel can compound sterile preparations aseptically and that the facility's processes prevent microbial contamination.

Question 39: What should be done if a sterility breach is suspected during the compounding process?

Discard the compromised preparation immediately and document the incident (Correct answer)
Continue compounding and report it at the end of the shift
Dilute the preparation to reduce contamination
Ignore the breach if it seems minor

Correct answer: Discard the compromised preparation immediately and document the incident

Any suspected sterility breach should be addressed immediately by discarding the preparation and documenting the incident to ensure patient safety.

Question 40: A total parenteral nutrition (TPN) admixture contains calcium and phosphate. The primary stability concern when assigning BUD is:

Lipid peroxidation
Microbial contamination from multiple additives
Calcium-phosphate precipitation (Correct answer)
Amino acid crystallization

Correct answer: Calcium-phosphate precipitation

Calcium-phosphate precipitation is the critical stability concern in TPN admixtures, potentially causing fatal pulmonary emboli if infused.

Question 41: What are the standard parameters for terminal sterilization of a preparation by moist heat (autoclave)?

130°C for 5 minutes at 20 psi
115°C for 30 minutes at 10 psi
121°C for a minimum of 15 minutes at 15 psi (Correct answer)
100°C for 30 minutes at atmospheric pressure

Correct answer: 121°C for a minimum of 15 minutes at 15 psi

The standard autoclave cycle is 121°C at 15 psi for at least 15 minutes. This combination of temperature and pressure is sufficient to achieve a sterility assurance level (SAL) of 10⁻⁶ for terminally sterilized preparations.

Question 42: According to USP <797>, what information must be documented in the compounding record that is NOT required on the patient label?

Identity and quantity of each component used (Correct answer)
Quantity dispensed
Patient name
Drug name and strength

Correct answer: Identity and quantity of each component used

The compounding record must document each individual component's identity and quantity, whereas the patient label shows only the final preparation's name and strength.

Question 43: Which documentation must be completed BEFORE beginning a non-sterile to sterile compounding process?

Post-preparation sterility test results
Patient administration log
Final product release certificate
Master formulation record review and compounding record initiation (Correct answer)

Correct answer: Master formulation record review and compounding record initiation

The master formulation record must be reviewed and a compounding record initiated prior to starting any compounding process to ensure accuracy and traceability.

Question 44: What is the proper procedure for handling a CSP accidentally frozen during storage?

Microwave to thaw quickly
Refreeze and extend the BUD
Thaw at room temperature and use normally
Assess the product as freezing can compromise stability; most should be discarded (Correct answer)

Correct answer: Assess the product as freezing can compromise stability; most should be discarded

Unintentional freezing can damage many CSPs. Unless stability data supports use after freeze-thaw, the CSP should be discarded.

Question 45: A technician notices their sterile gloves have small holes after removing them post-compounding. What is the most appropriate immediate action?

Continue work since the outer gloves likely remained intact
Re-glove and continue since gloves are the last line of defense
Report only if the batch will be used for high-risk patients
Document the incident and discard the batch compounded (Correct answer)

Correct answer: Document the incident and discard the batch compounded

Compromised gloves mean the integrity of the sterile field cannot be guaranteed, so the affected batch must be discarded and the incident documented.

Question 46: Under USP <797>, which of the following actions is required when a CSP's BUD has been exceeded?

Extend BUD if stored refrigerated
Relabel with a new BUD
Discard the preparation immediately (Correct answer)
Return to the pharmacist for re-evaluation

Correct answer: Discard the preparation immediately

Once a BUD has passed, the CSP must be discarded because its sterility and potency can no longer be assured.

Question 47: A compounding technician accidentally bumps the HEPA filter face while working inside the LAFW. The correct response is to:

Wipe the filter face with 70% IPA and immediately resume compounding
Stop work, re-disinfect all surfaces and materials in the LAFW, and allow adequate purge time before resuming (Correct answer)
Continue working since the HEPA filter is self-cleaning
Discard all prepared compounds and shut down the LAFW for the rest of the day

Correct answer: Stop work, re-disinfect all surfaces and materials in the LAFW, and allow adequate purge time before resuming

Touching the HEPA filter may disrupt airflow patterns; all surfaces must be re-disinfected and the unit allowed to purge for a sufficient time before compounding resumes.

Question 48: Which statistical method is used to determine if a compounding process is within acceptable limits by plotting data points over time?

Control chart (Shewhart chart) (Correct answer)
Pareto analysis
Fishbone diagram
Failure mode and effects analysis

Correct answer: Control chart (Shewhart chart)

Control charts (Shewhart charts) plot process data over time to detect trends or shifts that indicate the process is out of statistical control.

Question 49: What does a Biological Safety Cabinet (BSC) provide that a standard horizontal LAFW does not?

Higher air velocity
Reduced noise levels
Personnel protection through inward airflow at the front opening (Correct answer)
Better product sterility

Correct answer: Personnel protection through inward airflow at the front opening

A BSC provides both product protection and personnel protection through inward airflow at the front opening and downward HEPA-filtered air.

Question 50: Which of the following is classified as a Group 2 hazardous drug under NIOSH criteria?

Doxorubicin (antineoplastic)
Methotrexate (antineoplastic)
Cyclophosphamide (antineoplastic)
Warfarin (reproductive risk only, non-antineoplastic) (Correct answer)

Correct answer: Warfarin (reproductive risk only, non-antineoplastic)

NIOSH Group 2 includes non-antineoplastic drugs that meet one or more hazard criteria; warfarin poses a reproductive risk, placing it in Group 2.

Question 51: How frequently must viable air sampling (active air monitoring) be performed in a cleanroom buffer area under USP <797>?

Every 6 months
Monthly (Correct answer)
Every 3 months
Annually

Correct answer: Monthly

USP <797> (2023) requires viable air sampling in the buffer area to be performed at least monthly.

Question 52: During compounding, a technician drops a syringe tip on the LAFW work surface but it does not contact anything outside the hood. What should the technician do?

Cap the syringe immediately and continue if work is time-sensitive
Discard the syringe and obtain a new sterile one (Correct answer)
Wipe the tip with 70% IPA and continue
Pick it up and continue use since it stayed inside the ISO 5 area

Correct answer: Discard the syringe and obtain a new sterile one

Any component that contacts an unsterile or uncertain surface—including the LAFW work surface itself—must be discarded because sterility cannot be guaranteed.

Question 53: Spent sharps (needles, syringes) used during sterile compounding of hazardous drugs must be disposed of in what manner?

Clipped using a needle destroyer, then placed in regular trash
In any red biohazard sharps container, treated the same as non-hazardous sharps
In a standard chemotherapy waste container without a sharps container
In a puncture-resistant sharps container that is also appropriate for chemotherapy-contaminated sharps, then disposed of as chemotherapy waste (Correct answer)

Correct answer: In a puncture-resistant sharps container that is also appropriate for chemotherapy-contaminated sharps, then disposed of as chemotherapy waste

Sharps contaminated with hazardous drugs must be placed in a puncture-resistant sharps container that is also labeled and designated for chemotherapy waste. They cannot be disposed of in standard (red) infectious waste sharps containers because of the chemical hazard. Needle clipping is prohibited under OSHA bloodborne pathogen standards.

Question 54: Why is pharmacist verification of the final CSP a critical quality control step?

It is a legal formality only
Only required for controlled substances
It allows the pharmacist to add forgotten ingredients
The pharmacist performs an independent check of ingredients, quantities, technique, labeling, and appearance (Correct answer)

Correct answer: The pharmacist performs an independent check of ingredients, quantities, technique, labeling, and appearance

Pharmacist verification provides an independent expert review of the entire compounding process.

Question 55: A compounding technician is preparing an ophthalmic solution and must filter the preparation. Which filter pore size is appropriate?

0.45 micron
0.22 micron (Correct answer)
5 micron
1 micron

Correct answer: 0.22 micron

A 0.22-micron filter is used for sterilization of ophthalmic and other sterile preparations, removing bacteria and particulates.

Question 56: Per USP <797>, how often must surface sampling for microbial contamination be performed in an ISO 5 PEC during Category 2 compounding?

Weekly
Monthly (Correct answer)
Annually
Every 6 months

Correct answer: Monthly

USP <797> requires surface sampling in ISO 5 PECs used for Category 2 CSPs to be performed at least monthly.

Question 57: Which filter pore size is appropriate for administering a total nutrient admixture (3-in-1 TPN containing lipids)?

0.45 micron
1.2 micron (Correct answer)
5 micron
0.22 micron

Correct answer: 1.2 micron

A 1.2-micron filter is used for 3-in-1 TPN to allow lipid droplets to pass through while removing larger particulates.

Question 58: You are preparing an IV admixture and need to add calcium gluconate 1 g. The available vial is 10% (100 mg/mL). How many mL do you draw up?

100 mL
5 mL
1 mL
10 mL (Correct answer)

Correct answer: 10 mL

1 g = 1000 mg; 1000 mg ÷ 100 mg/mL = 10 mL.

Question 59: Which personal protective equipment (PPE) is essential for CSPTs when preparing sterile compounds?

Lab coat and gloves
Shoe covers and apron
Safety glasses and ear plugs
Hair cover, face mask, gown, and sterile gloves (Correct answer)

Correct answer: Hair cover, face mask, gown, and sterile gloves

Proper PPE, including hair cover, face mask, gown, and sterile gloves, is necessary to maintain sterility and prevent contamination.

Question 60: A compounding technician notices that the pressure differential gauge between the buffer room and anteroom reads a positive value in a hazardous drug compounding suite. This indicates:

Normal — all compounding areas require positive pressure
A problem — hazardous drug rooms must maintain negative pressure relative to adjacent areas (Correct answer)
Acceptable only if the HEPA filter is certified ISO Class 5
A minor calibration issue that can be corrected during next scheduled maintenance

Correct answer: A problem — hazardous drug rooms must maintain negative pressure relative to adjacent areas

Hazardous drug compounding areas must maintain negative pressure (≥0.01–0.03 inch water column) relative to adjacent spaces to contain drug particles and protect personnel.

Question 61: What is the purpose of sporicidal cleaning in a sterile compounding facility?

To make surfaces shine
To kill bacterial spores that are resistant to standard disinfectants like 70% IPA (Correct answer)
To prevent rust on stainless steel
Not necessary in pharmacy settings

Correct answer: To kill bacterial spores that are resistant to standard disinfectants like 70% IPA

Sporicidal agents kill bacterial endospores that survive standard disinfection with 70% IPA.

Question 62: What is the significance of establishing action levels (vs. alert levels) in environmental monitoring programs?

Alert levels require the facility to shut down, while action levels only require documentation
Action levels are set lower than alert levels to provide an early warning
Action and alert levels are interchangeable terms with no practical difference
Action levels require mandatory investigation and corrective action, while alert levels signal a trend requiring increased vigilance (Correct answer)

Correct answer: Action levels require mandatory investigation and corrective action, while alert levels signal a trend requiring increased vigilance

Alert levels indicate a potential drift from normal conditions and prompt review, whereas action levels mandate immediate investigation, corrective action, and documentation to prevent patient harm.

Question 63: What is the correct order of steps when doffing (removing) PPE after hazardous drug compounding?

Shoe covers → outer gloves → gown → inner gloves → head cover → mask → hand wash (Correct answer)
Mask → gown → outer gloves → shoe covers → inner gloves → hand wash
Outer gloves → gown → shoe covers → inner gloves → mask/respirator → hand wash
Gown → outer gloves → shoe covers → inner gloves → mask → hand wash

Correct answer: Shoe covers → outer gloves → gown → inner gloves → head cover → mask → hand wash

The correct doffing sequence removes the most contaminated outer items first (shoe covers, outer gloves, gown) before removing inner gloves, head cover, and mask to minimize self-contamination.

Question 64: What is the purpose of a medication use evaluation (MUE) for compounded sterile preparations?

To evaluate medication taste
To plan the pharmacy budget
To systematically evaluate prescribing, dispensing, and administration patterns to improve quality and safety (Correct answer)
To negotiate drug pricing

Correct answer: To systematically evaluate prescribing, dispensing, and administration patterns to improve quality and safety

An MUE examines how CSPs are prescribed, prepared, and administered, identifying improvement opportunities.

Question 65: Under USP <797>, which category of compounded sterile preparations (CSPs) requires the most stringent environmental monitoring and testing?

Category 1 CSPs with short beyond-use dates
Category 2 CSPs intended for longer storage periods (Correct answer)
Immediate-use CSPs prepared at the patient bedside
Radiopharmaceuticals compounded on-site

Correct answer: Category 2 CSPs intended for longer storage periods

Category 2 CSPs, which are assigned longer beyond-use dates, require the most stringent environmental monitoring, personnel qualification, and quality testing under USP <797>.

Question 66: A compounding facility is using a biological safety cabinet (BSC) Class II Type A2 for hazardous drug compounding. What pressure relationship must the hazardous drug compounding room maintain relative to adjacent spaces?

Positive pressure (≥0.02-inch water column)
Negative pressure (≥0.05-inch water column)
Neutral pressure
Negative pressure (≥0.01-inch water column) (Correct answer)

Correct answer: Negative pressure (≥0.01-inch water column)

Rooms used for hazardous drug compounding must be maintained at negative pressure (at least 0.01-inch water column) relative to adjacent spaces to contain any drug vapors or aerosols within the compounding area.

Question 67: According to USP <797> labeling requirements, which of the following must be clearly displayed on the label of every compounded sterile preparation?

The beyond-use date (BUD). (Correct answer)
The wholesale supplier of the active ingredient.
The ISO class of the room where it was prepared.
The cost of the preparation.

Correct answer: The beyond-use date (BUD).

The beyond-use date (BUD) is a core requirement for all CSP labels. The BUD indicates the date and time after which the preparation should not be used, ensuring its sterility and stability for patient safety. Other information like cost, supplier, or ISO class is part of facility records but not required on the final patient label.

Question 68: A compounder is working in a BSC (biological safety cabinet) and accidentally places their arm over an open vial. What contamination risk does this create?

Reduced UV radiation inside the BSC
Disruption of vertical airflow, allowing non-sterile air or particles to fall into the vial (Correct answer)
Increased static electricity on the vial stopper
Backflow of HEPA air into the vial

Correct answer: Disruption of vertical airflow, allowing non-sterile air or particles to fall into the vial

In a BSC, airflow moves vertically downward; placing an arm over an open critical site blocks that sterile downflow and creates a contamination pathway.

Question 69: After compounding a sterile hazardous drug, a technician must dispose of the outer pair of chemotherapy gloves. According to USP <800>, where should these gloves be discarded?

In a red biohazard bag designated for infectious waste.
In a regular trash can located outside the buffer room.
In an approved waste container inside the PEC or a sealable bag for disposal outside the PEC. (Correct answer)
In a sharps container within the Primary Engineering Control (PEC).

Correct answer: In an approved waste container inside the PEC or a sealable bag for disposal outside the PEC.

USP <800> specifies that all PPE worn when handling HDs is considered contaminated. Chemotherapy gloves used during compounding must be discarded in a waste container approved for trace-contaminated waste located inside the Primary Engineering Control (PEC). Alternatively, they can be placed in a sealable bag inside the PEC and then discarded in an appropriate container outside the PEC.

Question 70: A beyond-use date (BUD) policy allows 12 hours at room temperature for a sterile preparation. If compounding is completed at 09:30, what is the latest BUD time?

21:30 (Correct answer)
09:30 the next day
21:00
19:30

Correct answer: 21:30

09:30 + 12 hours = 21:30.

Question 71: When reconstituting a powdered drug, what must be verified before adding the diluent?

The weight of the empty vial
The color of the powder
The brand name matches preferred formulary
The correct diluent type, volume, and compatibility as specified by manufacturer or formulation record (Correct answer)

Correct answer: The correct diluent type, volume, and compatibility as specified by manufacturer or formulation record

Before reconstitution, verify the correct diluent type and volume as these are NOT interchangeable and affect drug stability and potency.

Question 72: A technician prepares 10 syringes of morphine 2 mg/mL but realizes after labeling that morphine 20 mg/mL was used. Which of the following describes this error type?

Near miss with no patient exposure
Documentation error only
Wrong drug error
10-fold concentration error (high-alert medication error) (Correct answer)

Correct answer: 10-fold concentration error (high-alert medication error)

Using morphine 20 mg/mL instead of 2 mg/mL creates a 10-fold concentration error involving a high-alert medication, representing a serious medication error.

Question 73: Which of the following is a required component of INITIAL competency qualification for personnel who will compound Category 2 CSPs under USP <797>?

Oral examination administered by the director of pharmacy
Completion of a nationally accredited pharmacy technician training program
Written or oral competency assessment, aseptic technique observation, successful media fill, and passing gloved fingertip/thumb sampling (Correct answer)
Shadowing an experienced compounder for a minimum of 40 hours

Correct answer: Written or oral competency assessment, aseptic technique observation, successful media fill, and passing gloved fingertip/thumb sampling

USP <797> requires a comprehensive initial competency assessment for Category 2 compounders that includes: (1) written or oral knowledge assessment, (2) direct observation of aseptic technique, (3) successful media fill, and (4) passing GFT sampling results. All four components must be successfully completed before independent compounding is permitted.

Question 74: A single-dose vial of a sterile diluent is opened and used to prepare a CSP. Per USP <797>, any unused portion must be discarded within:

4 hours
1 hour
24 hours
12 hours (Correct answer)

Correct answer: 12 hours

Once a single-dose vial is opened or needle-punctured, USP <797> requires discard within 12 hours to prevent microbial contamination.

Question 75: Which cleaning agent is recommended for daily cleaning of the interior surfaces of a LAFW?

Quaternary ammonium compound
Bleach solution only
Hydrogen peroxide 3%
Sterile 70% isopropyl alcohol (Correct answer)

Correct answer: Sterile 70% isopropyl alcohol

Sterile 70% IPA is the standard agent for daily cleaning of LAFW interior surfaces.

CSPT Certified Compounded Sterile Preparation Technician Exam

The PTCB CSPT exam certifies pharmacy technicians in sterile compounding, covering medications, facilities, compounding procedures, and handling per USP <797> standards.

Questions

120 min

Time Limit

70%

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