CSPT Labeling and Documentation 5 — Questions and Answers
Question 1: A technician compounds a CSP with a 14-day BUD but the prescriber orders a 30-day supply for a home infusion patient. What is the correct action?
- Label with 30 days because the prescriber ordered it
- Label with 14 days and dispense multiple units to cover the 30-day supply (Correct answer)
- Label with 30 days and refrigerate
- Dispense as a single unit with a 30-day BUD
Correct answer: Label with 14 days and dispense multiple units to cover the 30-day supply
The BUD must reflect the scientifically supported stability limit; multiple units with correct BUDs should be dispensed to cover the full therapy course.
Question 2: Which element on a CSP label helps ensure the preparation can be recalled if a sterility or quality issue is discovered after dispensing?
- Prescriber's NPI number
- Lot number or batch number (Correct answer)
- Dispensing pharmacist's license number
- Insurance authorization code
Correct answer: Lot number or batch number
The lot or batch number links the dispensed preparation back to the specific compounding run, enabling targeted recalls without disrupting unaffected batches.
Question 3: Under USP <797>, which of the following CSPs would require a 'single-dose only' or 'discard after use' notation?
- Multi-dose vials with preserved formulations
- Unit-dose syringes without antimicrobial preservatives (Correct answer)
- Batch preparations stored in sealed multi-dose containers
- Preparations dispensed in original manufacturer vials
Correct answer: Unit-dose syringes without antimicrobial preservatives
Unpreserved unit-dose syringes must be labeled to indicate they should be discarded after a single use to prevent microbial contamination.
Question 4: A CSP label is damaged and illegible by the time it reaches the patient's home nurse. What is the nurse's safest course of action?
- Administer the medication based on prior knowledge of the order
- Contact the pharmacy for a replacement label or preparation before administration (Correct answer)
- Apply a new handwritten label based on the order
- Return the preparation to the refrigerator and use it the next day
Correct answer: Contact the pharmacy for a replacement label or preparation before administration
A medication should never be administered if its label is unreadable; the pharmacy must be contacted to verify all preparation details and provide a legible label.
Question 5: When compounding a CSP for a patient with a documented allergy to a dye used in formulation, where should this substitution be documented?
- On the patient's insurance profile only
- In the compounding record and noted on the label as 'dye-free formulation' (Correct answer)
- Verbally to the nurse only
- On the medication administration record only
Correct answer: In the compounding record and noted on the label as 'dye-free formulation'
Any formulation deviation due to allergy or patient-specific need must be documented in the compounding record and communicated on the label to alert all caregivers.
Question 6: 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
- Quarantine and do not dispense; notify the pharmacist for proper disposal (Correct answer)
- Cross out the BUD and write the correct date
- Relabel with a new BUD if the preparation appears visually acceptable
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 7: Which of the following scenarios demonstrates correct label accuracy verification practice for a sterile compounded preparation?
- The technician checks the label once during filling and files it without pharmacist review
- A second technician and the pharmacist independently verify the label against the compounding order before dispensing (Correct answer)
- The nurse verifies the label only at bedside
- The label is verified only if the prescriber requests a second check
Correct answer: A second technician and the pharmacist independently verify the label against the compounding order before dispensing
Independent double-verification by both a technician and pharmacist against the original order is required to catch label errors before the CSP reaches the patient.
CSPT Labeling and Documentation 5
A technician compounds a CSP with a 14-day BUD but the prescriber orders a 30-day supply for a home infusion patient.
What is the correct action?