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Cold chain excursion — GPhC CRA MCQ

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HardDispensing and SupplyCold chain excursionGPhC CRA

During opening checks, the pharmacy fridge log shows 11C for 3 hours overnight after the door was not fully closed. It contains insulin, vaccines and unopened eye drops requiring refrigeration. A dispenser asks whether to continue supplying them. What is the legal classification/requirement?

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

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Correct answer: E — quarantine affected stock and assess stability before supply

A cold-chain excursion can affect medicine quality and patient safety. Affected stock should be quarantined while product stability is checked with manufacturers, wholesalers or local procedures. Returning items to the fridge does not prove they remain suitable. The incident should be documented and stock should not be supplied until suitability is established.

Reference: MEP; SmPC