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Cold chain breach — GPhC CRA MCQ

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HardDispensing and SupplyCold chain breachGPhC CRA

A delivery of exenatide pens arrived after a fridge failure in the van. The temperature logger shows 15°C for 9 hours, then 8°C for 2 hours. The wholesaler asks the pharmacy to decide whether to accept the stock for dispensing today. What is the legal classification/requirement?

Educational content. Not a substitute for clinical judgement or local policy.

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Correct answer: B — Quarantine the stock and obtain stability advice before supply

Cold chain medicines exposed to temperatures outside specified limits should be quarantined while stability advice is obtained from the manufacturer or wholesaler. Returning to fridge temperature does not guarantee maintained quality. Freezing may damage the medicine further. Dispensing before assessment risks patient harm and governance failure.

Reference: Product SmPC; MEP; GDP cold chain guidance