21 Compounding Procedures & Quality Practice Questions & Answers

1. 1. A pharmacy will prepare a batch of antibiotic syringes for several different patients. Which document must be in place before compounding begins, describing the approved way this preparation is to be made?

   • A.The certificate of analysis that accompanies a conventionally manufactured product
   • B.The compounding record, which captures the lot numbers of the components actually used
   • C.The master formulation record, which lists the ingredients, equipment and the full procedure✓ Answer
   • D.The safety data sheet kept on file for every hazardous substance handled on site

   The master formulation record is the approved recipe written before the work begins: it names the ingredients and their amounts, the equipment, the step-by-step method, the container closure, the storage conditions and the quality checks. It is required whenever a preparation is made for more than one patient or from any nonsterile component. The compounding record is written during and after the work and documents what was actually made on that occasion.

   Source: USP General Chapter <797> Pharmaceutical Compounding — Sterile Preparations, master formulation recordsReport a problem with this question

2. 2. A technician has just finished preparing an order and is completing the paperwork. Which item belongs in the compounding record rather than in the master formulation record?

   • A.The container closure system specified for the finished preparation
   • B.The manufacturer, lot number and expiration date of each component used✓ Answer
   • C.The quality control procedures to be performed before any unit is released
   • D.The step-by-step compounding instructions approved for this formulation

   The compounding record is the account of one specific occasion, so it captures the facts that only exist once the work is done: the actual components with manufacturer, lot number and expiration date, the date and time, the assigned internal identification or lot number, the quantity made, who compounded and who verified, the calculations, and the assigned beyond-use date. The other three items are written in advance in the master formulation record and apply to every batch of that formulation.

   Source: USP General Chapter <797>, compounding records for compounded sterile preparationsReport a problem with this question

3. 3. Why does the compounding record capture the manufacturer, lot number and expiration date of every component used?

   • A.It allows the beyond-use date to be extended whenever a component expires far ahead
   • B.It replaces the visual inspection otherwise performed before a preparation is released
   • C.It documents that a commercially manufactured product was chosen over a bulk substance
   • D.It lets the pharmacy find and retrieve every preparation containing a recalled lot✓ Answer

   Lot-level documentation creates traceability in both directions: from a recalled or defective component forward to every preparation that contains it, and from a patient's preparation backward to the exact components used. Without it a recall would force the pharmacy to guess, and preparations already dispensed could not be identified. A component's own expiration date never lengthens the beyond-use date, which is set by the preparation's own risk and storage.

   Source: USP General Chapter <797>, component documentation and recall of compounded preparationsReport a problem with this question

4. 4. A compounded intravenous bag is being sent to a nursing unit. Which information must the label carry so the person who administers it can use it safely?

   • A.The beyond-use date and the storage conditions that apply✓ Answer
   • B.The date the primary engineering control was last certified
   • C.The name and address of the manufacturer of each component
   • D.The lot numbers of every component that went into the preparation

   The label speaks to the person at the bedside, so it must carry what that person needs to give the dose safely: the active ingredients and their amounts, the beyond-use date, and the storage conditions the preparation requires, along with an indication that the product was compounded. Component lot numbers and facility certification dates are traceability and quality records that belong in the pharmacy's files, not on the administration label.

   Source: USP General Chapter <797>, labeling of compounded sterile preparationsReport a problem with this question

5. 5. In one shift a technician prepares a single dose for one patient from a commercially available sterile vial, and later prepares a solution that starts from a nonsterile powder. Which statement about the master formulation record is correct?

   • A.It is required only when a batch is larger than the pharmacy's usual daily volume
   • B.It is required only when an automated compounding device performs the transfers
   • C.It is required for every dose that will be administered to a hospital inpatient
   • D.It is required for the preparation that begins from the nonsterile powder✓ Answer

   A master formulation record is triggered by two situations: a preparation made for more than one patient, and any preparation made from one or more nonsterile components. The single patient-specific dose drawn from a commercially manufactured sterile vial meets neither trigger, while the solution starting from nonsterile powder meets the second one, because that workflow requires a defined sterilization step and defined controls that must be written down in advance.

   Source: USP General Chapter <797>, when a master formulation record is requiredReport a problem with this question

6. 6. A pharmacist decides that the diluent volume written in an existing master formulation record should be changed. How must the change be handled?

   • A.The change may be made verbally if the pharmacist checks the finished units
   • B.The technician notes the new volume on the compounding record and continues
   • C.The change is reviewed, approved and documented under facility procedures first✓ Answer
   • D.The record is discarded and rewritten by the technician who noticed the issue

   The master formulation record is a controlled document, so any change to it goes through the facility's review and approval process and is documented before the revised version is used to compound. Verbal changes and margin notes leave no auditable trail, and destroying the original removes the history that an investigation or recall would need. Personnel then work only from the current approved version.

   Source: PTCB CSPT Content Outline, Sterile Compounding Procedures — documentation and standard operating proceduresReport a problem with this question

7. 7. A technician must draw up a small volume of a concentrated drug. Which choice gives the most accurate measurement?

   • A.The smallest syringe that will still hold the entire volume needed✓ Answer
   • B.A syringe whose capacity is several times the volume being measured
   • C.Any syringe, with the reading corrected afterward by weighing the container
   • D.The largest syringe on hand, because its barrel markings are easier to read

   Accuracy depends on how much of the device's scale the measurement occupies. On an oversized syringe the same small volume falls near the bottom of a coarse scale, so the graduations are widely spaced in volume terms and a small reading error becomes a large percentage error in the dose. Choosing the smallest syringe that still holds the volume puts the reading on a finer scale and in its more reliable range.

   Source: PTCB CSPT Content Outline, Sterile Compounding Procedures — accurate weighing and measuring of componentsReport a problem with this question

8. 8. Where should the volume be read on a syringe that has been filled?

   • A.At the top of the meniscus seen through the barrel of the syringe
   • B.At the edge of the rubber stopper that is closest to the syringe tip✓ Answer
   • C.At the midpoint of the rubber stopper, whichever graduation it covers
   • D.At the far edge of the rubber stopper, nearest the plunger flange handle

   The liquid column ends where the leading edge of the rubber stopper sits, so that edge — the one facing the syringe tip — marks the volume actually contained. Reading the trailing edge or the raised centre of the stopper adds the stopper's own thickness to the measurement and overstates the dose. A meniscus is read in a graduate or a glass cylinder, not inside a syringe barrel.

   Source: PTCB CSPT Content Outline, Sterile Compounding Procedures — measuring volumes with syringesReport a problem with this question

9. 9. A dose of a high-alert drug must be verified as accurately as possible. Why can weighing the syringe be more reliable than reading its graduations?

   • A.Weighing also confirms the identity of the drug that was drawn into it
   • B.A weight taken on a calibrated balance does not depend on how a mark is read✓ Answer
   • C.Weighing removes the need to record the lot number of the component used
   • D.A balance reading shows that the preparation is free of microbial contamination

   Volumetric measurement depends on a human eye lining up a stopper edge with a printed graduation, and parallax, an oversized device or a hurried reading all introduce error. A gravimetric check converts the delivered amount into a mass on a calibrated balance, using the solution's known density, so it does not inherit those reading errors and it produces a number that can be recorded. It says nothing about which drug was used or whether the preparation is sterile — those still depend on the component check and on aseptic practice.

   Source: PTCB CSPT Content Outline, Sterile Compounding Procedures — volumetric and gravimetric measurementReport a problem with this question

10. 10. In a pull-back check, the plunger is left drawn back to the volume added and the syringe is shown to the pharmacist together with the empty vials. What is the main limitation of this method?

    • A.It is valid only when a single additive goes into the final container
    • B.It requires the verifying pharmacist to stand inside the buffer room
    • C.It shows a volume in the syringe, not which drug was drawn into it✓ Answer
    • D.It cannot be used unless every component is drawn with one syringe size

    A pulled-back plunger is only evidence of an air volume in a barrel after the fact; it does not prove that that volume was ever transferred, and it cannot show which vial the liquid came from. If the wrong vial was selected, or the drug and the diluent were interchanged, the pull-back looks perfectly correct. That is why the empty containers must be presented for identity checking and why gravimetric or barcode verification is used where the consequence of an error is serious.

    Source: PTCB CSPT Content Outline, Sterile Compounding Procedures — verification of compounded dosesReport a problem with this question

11. 11. While a parenteral nutrition admixture is being compounded, which practice does most to reduce the risk of calcium phosphate precipitation?

    • A.Adding both salts to the amino acid concentrate before any dextrose
    • B.Adding the calcium salt and the phosphate one immediately after the other
    • C.Adding phosphate early in the sequence and calcium last, mixing between✓ Answer
    • D.Adding the calcium salt first so the phosphate meets a larger volume

    Calcium and phosphate form an insoluble salt when their concentrations meet at a high local level, so the goal is to keep them from ever being concentrated together. Adding the phosphate early lets it disperse through the amino acid and dextrose volume, and adding calcium last, after mixing, means it enters an already dilute solution where the local product of the two never reaches the point of precipitation. Precipitation risk also rises with higher concentrations, higher pH and higher temperature, and a precipitate in a parenteral nutrition bag can embolise and kill.

    Source: USP General Chapter <797>, compounding of parenteral nutrition admixtures; ASHP guidance on calcium and phosphate compatibilityReport a problem with this question

12. 12. A parenteral nutrition admixture is transferred by an automated compounding device. Why must the device's delivery accuracy be verified?

    • A.Because the device assigns the beyond-use date after each accuracy check
    • B.Because the device cannot be used with concentrated electrolyte solutions
    • C.Because a calibration or tubing error would misdeliver every additive it pumps✓ Answer
    • D.Because that verification takes the place of inspecting the finished bag

    An automated compounding device repeats the same pumping action for every bag, so an error in its calibration, in the specific gravity entered for a solution, or in how the tubing set is loaded is not a single mistake but a systematic one reproduced in every unit until it is caught. Accuracy is therefore confirmed independently, typically by weighing a delivered volume and comparing it against the expected mass. The device does not assign beyond-use dates and does not replace the visual inspection of the finished admixture.

    Source: PTCB CSPT Content Outline, Sterile Compounding Procedures — automated compounding devices for parenteral nutritionReport a problem with this question

13. 13. An order calls for an intrathecal preparation. The only vial of that drug in stock is a multiple-dose vial containing a preservative. What should the technician do?

    • A.Filter the preservative out of the solution before it is dispensed
    • B.Dilute the dose so the preservative concentration becomes trivial
    • C.Obtain a preservative-free product before the dose is prepared✓ Answer
    • D.Label the syringe to show a preservative-containing vial was used

    Preparations given into the epidural or intrathecal space must be preservative-free, because antimicrobial preservatives are neurotoxic when placed in contact with the spinal cord and nerve roots and have caused arachnoiditis and permanent injury. A preservative is dissolved in the solution, so it cannot be filtered out, and diluting it does not make it safe. The correct action is to stop and source a preservative-free product, escalating to the pharmacist if none is available.

    Source: USP General Chapter <797>, specialized compounded sterile preparations for epidural and intrathecal administrationReport a problem with this question

14. 14. Which requirement applies to a compounded ophthalmic preparation?

    • A.It must contain a preservative no matter how it is to be administered
    • B.It must be made with bacteriostatic water so it can be used repeatedly
    • C.It must be sterile and near isotonic so it does not injure the eye✓ Answer
    • D.It may be prepared on an open bench because the eye is not sterile tissue

    Ophthalmic preparations are placed on or into an immune-privileged tissue where an infection can destroy sight quickly, so sterility is not negotiable and preparation takes place under aseptic conditions in a primary engineering control. Tonicity matters because a markedly hypotonic or hypertonic solution damages the corneal epithelium and causes pain and tearing that washes the dose away. Intraocular preparations must additionally be preservative-free, since preservatives are toxic to internal ocular structures.

    Source: USP General Chapter <797>, compounded ophthalmic preparationsReport a problem with this question

15. 15. A patient will infuse an antibiotic at home from an elastomeric pump that the pharmacy fills. Which consideration matters most when the device is filled?

    • A.The reservoir may be topped off at home once the volume starts to run low
    • B.The pump has to be primed by the caregiver just before the first dose runs
    • C.The device removes the need to assign a beyond-use date to the filled unit
    • D.The drug must stay stable across the whole infusion at the temperature it sees✓ Answer

    An ambulatory reservoir is filled once and then delivers over hours or days, often carried against the body or held at room temperature rather than refrigerated, so the drug must remain chemically stable and compatible with the reservoir material for the entire delivery period under those conditions. The pharmacy checks stability data for the concentration, diluent and container before filling, and assigns a beyond-use date accordingly. A filled reservoir is a closed sterile system and is never refilled or topped off outside the pharmacy.

    Source: PTCB CSPT Content Outline, Sterile Compounding Procedures — specialized preparations including ambulatory infusion devicesReport a problem with this question

16. 16. What does a closed-system drug-transfer device accomplish during hazardous drug compounding?

    • A.It sterilizes the solution as it passes from the vial into the syringe
    • B.It measures the dose by weight as the drug moves into the syringe
    • C.It permits a hazardous drug to be compounded on an open counter top
    • D.It blocks the escape of drug and vapor and keeps outside contaminants out✓ Answer

    A closed-system drug-transfer device is defined by what it prevents: it mechanically prohibits the transfer of environmental contaminants into the system and the escape of hazardous drug or vapor concentration out of it, usually through an air-balancing or vapor-trapping mechanism at every connection. It protects the worker from exposure, but it neither sterilizes nor measures anything, and it does not substitute for a ventilated containment cabinet or for the required containment room and personal protective equipment.

    Source: USP General Chapter <800>, closed system drug-transfer devicesReport a problem with this question

17. 17. A vial of a hazardous drug is dropped and breaks on the floor outside the containment cabinet. What is the correct first response?

    • A.Finish the batch in progress so the doses already started are not wasted
    • B.Alert others, restrict access and use the spill kit with protection✓ Answer
    • C.Lay absorbent towels over the spill and leave it for housekeeping staff
    • D.Wipe the area with the sporicidal agent used for routine room cleaning

    A broken hazardous drug container releases both liquid and airborne particles, so the first priority is to stop anyone from walking through it or breathing it: alert people nearby, mark and restrict the area, and then don the protective equipment in the spill kit, including respiratory and eye protection, before containing the spill from the outside inward. The spill kit exists so that everything needed is immediately at hand wherever hazardous drugs are handled. Trained personnel manage the cleanup, the event is reported per policy, and the waste goes into hazardous drug waste containers.

    Source: USP General Chapter <800>, hazardous drug spill control and spill kitsReport a problem with this question

18. 18. A solution is prepared from a nonsterile bulk powder using careful aseptic technique inside the primary engineering control. Which statement is correct?

    • A.It must still be sterilized, since aseptic technique cannot make it sterile✓ Answer
    • B.It needs sterilization only if it will be given by the epidural route
    • C.It becomes sterile as soon as the powder dissolves in sterile water for injection
    • D.It is sterile because it never left the primary engineering control used

    Aseptic technique preserves sterility that already exists; it cannot create it. A nonsterile starting material carries its own microbial and possibly endotoxin load into the preparation, so that load must be removed or destroyed by a defined sterilization step — terminal sterilization where the product tolerates it, otherwise sterilizing-grade filtration. Dissolving the powder in sterile water only distributes the contamination through the solution, and the requirement applies whatever the route of administration.

    Source: USP General Chapter <797>, compounding from nonsterile components and required sterilizationReport a problem with this question

19. 19. For a heat-stable preparation made from nonsterile components, why is terminal sterilization preferred over sterilizing-grade filtration?

    • A.Terminal sterilization removes the need to inspect the finished container
    • B.Filtration is not allowed for any preparation with a nonsterile ingredient
    • C.Terminal sterilization also destroys any endotoxin present in the solution
    • D.The product is sterilized inside its final sealed container, after it is filled✓ Answer

    With terminal sterilization the lethal process is applied after the product is filled and the container is sealed, so every step that could reintroduce organisms has already happened and the sealed unit is what gets sterilized. Filtration sterilizes the stream of liquid instead, which leaves the filling, stoppering and sealing steps downstream of the sterilizing step and dependent on aseptic technique. Filtration is a legitimate route when heat would degrade the product, but it also does not remove endotoxin, which is why depyrogenation and endotoxin testing are separate requirements.

    Source: USP General Chapter <797>, terminal sterilization and sterilizing-grade filtrationReport a problem with this question

20. 20. During final inspection a technician notices a faint haze in one bag that the other bags of the same batch do not show. What should be done?

    • A.Filter the contents into a fresh container and dispense that bag instead
    • B.Swirl the bag until the haze clears and then release the preparation
    • C.Dispense it and ask the nurse to look at the bag again before hanging
    • D.Set the bag aside, do not dispense it, and tell the pharmacist✓ Answer

    Haze, cloudiness, particulates, discoloration, precipitate, leakage or a compromised seal are all evidence that something is wrong with the preparation — an incompatibility, a contaminant or a container failure — and a preparation showing any of them is never released. The bag is quarantined and referred to the pharmacist, who investigates the cause and decides on disposition, and the event is documented. Filtering or shaking a defective unit hides the defect without removing the cause and can leave the patient with an unsafe dose.

    Source: USP General Chapter <797>, inspection of compounded sterile preparations before releaseReport a problem with this question

21. 21. Units from a batch were dispensed before the sterility test result came back, and the result has now returned positive. What must the pharmacy do?

    • A.Record the result in the compounding record and move on to the next batch
    • B.Notify the prescriber, recall dispensed units and quarantine the stock✓ Answer
    • C.Notify the prescriber only if a patient has reported a reaction already
    • D.Repeat the test on a retained unit and release the stock if it passes

    When a preparation is dispensed or administered before release testing is complete, the written procedures must require immediate notification of the prescriber if a test then fails, so that patients who received the units can be assessed, together with recall of the unused dispensed units and quarantine of anything remaining in stock. An investigation follows into the cause and into whether other lots are affected, and it is documented. Retesting to obtain a passing result does not undo a failure, and the failing preparation is never released.

    Source: USP General Chapter <797>, release testing and action when a compounded preparation fails sterility testingReport a problem with this question

Practice questions based on the PTCB CSPT Content Outline and the USP General Chapters governing sterile compounding. CSPT and PTCB are marks of the Pharmacy Technician Certification Board; this site is not affiliated with or endorsed by PTCB or USP. Standards for sterile compounding are revised periodically and your state board of pharmacy and your employer's policies also apply — always follow your facility's current procedures and confirm current requirements before testing. About the CSPT exam →