Unlicensed medicine — GPhC CRA MCQ
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Correct answer: C — Source 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