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Unlicensed medicine — GPhC CRA MCQ

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HardPharmacy Law and EthicsUnlicensed medicineGPhC CRA

A dermatologist prescribes an unlicensed oral liquid because no licensed UK product, suitable licensed formulation or clinically appropriate licensed off-label option can meet a child’s documented need. What is the most defensible pharmacy response?

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

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Correct answer: CSource the special through an authorised route, document the special clinical need and maintain the required supply records and counselling

An unlicensed special may be supplied to meet a genuine special clinical need when suitable licensed options have been considered and found inappropriate. The pharmacy must use a lawful authorised supply route, preserve records, assure quality and give suitable information; the prescription does not transfer all professional responsibility. A waiver does not authorise importation, and licensed-status hierarchy does not justify clinically unsuitable unilateral substitution.

Reference: MHRA: supply unlicensed medicinal products (specials). https://www.gov.uk/government/publications/supply-unlicensed-medicinal-products-specials