CSPT Storage, Handling, and Transport 4 — Questions and Answers
Question 1: A CSP labeled 'Protect from Light' must be stored in which of the following?
- Clear glass vial in a standard cabinet
- Amber vial or light-resistant packaging (Correct answer)
- Open stainless steel tray under fluorescent lighting
- Refrigerator with transparent door
Correct answer: Amber vial or light-resistant packaging
Amber vials or light-resistant packaging block UV and visible light that can degrade photosensitive compounds.
Question 2: Which temperature range is defined as 'controlled room temperature' (CRT) per USP standards?
- 2°C to 8°C
- 15°C to 30°C (Correct answer)
- 8°C to 15°C
- 30°C to 40°C
Correct answer: 15°C to 30°C
USP defines controlled room temperature as 20°C–25°C with excursions permitted between 15°C and 30°C.
Question 3: When transporting a hazardous CSP within a facility, what is the PRIMARY purpose of using a sealed, leak-proof container?
- To maintain sterility of the preparation
- To prevent spills and protect staff from exposure (Correct answer)
- To keep the preparation at the correct temperature
- To comply with labeling requirements
Correct answer: To prevent spills and protect staff from exposure
Sealed, leak-proof transport containers for hazardous drugs primarily protect personnel from accidental exposure during transit.
Question 4: A batch of CSPs is discovered to have been stored at 10°C instead of the required 2°C–8°C refrigeration range. What is the appropriate first action?
- Relabel the products with a new BUD
- Quarantine and evaluate per facility deviation procedures (Correct answer)
- Return the products to correct refrigeration and continue use
- Administer the products immediately to avoid further temperature excursion
Correct answer: Quarantine and evaluate per facility deviation procedures
Temperature excursions require quarantine and a formal deviation evaluation to determine whether products are still safe and effective.
Question 5: Which USP chapter governs the handling, storage, and transport of hazardous drugs in healthcare settings?
- USP <797>
- USP <800> (Correct answer)
- USP <795>
- USP <1076>
Correct answer: USP <800>
USP <800> specifically addresses hazardous drug handling, including storage, transport, and personnel protection requirements.
Question 6: A CSP requiring frozen storage is thawed and not used. Under USP <797>, it may generally NOT be refrozen because:
- Refreezing is prohibited by federal law
- Repeated freeze-thaw cycles can degrade drug potency and sterility assurance (Correct answer)
- Frozen CSPs must always be discarded after thawing
- Refreezing changes the BUD to immediate-use only
Correct answer: Repeated freeze-thaw cycles can degrade drug potency and sterility assurance
Repeated freeze-thaw cycles can cause physical degradation, potency loss, and increased microbial risk in CSPs.
Question 7: Which document should accompany a CSP during off-site transport to ensure proper chain-of-custody and storage compliance?
- A blank chain-of-custody form to be completed on arrival
- A transport log recording temperature monitoring and departure/arrival times (Correct answer)
- Only the patient prescription label
- An MSDS sheet for all ingredients
Correct answer: A transport log recording temperature monitoring and departure/arrival times
A transport log with temperature data and timing provides documented evidence that storage conditions were maintained during transit.
CSPT Storage, Handling, and Transport 4
A CSP labeled 'Protect from Light' must be stored in which of the following?