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Unlicensed medicine request — GPhC CRA MCQ

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ModeratePharmacy Law and EthicsUnlicensed medicine requestGPhC CRA

A GP asks the pharmacy to source an unlicensed special because the licensed product is unsuitable. The patient asks whether this is allowed. What is the legal classification/requirement?

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Correct answer: E — Supply may be appropriate where there is a special clinical need

Unlicensed medicines can be supplied where a licensed medicine is unsuitable and there is a special clinical need. The pharmacist must ensure appropriate procurement, labelling and records. In this scenario, the correct option is supply may be appropriate where there is a special clinical need. The other options are plausible but do not address the key clinical, legal or safety issue as directly. This aligns with UK pharmacy practice guidance cited in the reference field.

Reference: Human Medicines Regulations 2012; MEP