An occasional feature, prepared in the Royal Pharmaceutical Society’s Professional Standards Directorate, to highlight problems and inquiries currently being handled

Unlicensed products for dispensing

It has been brought to the Professional Standards Directorate's attention that there are products labelled as, for example, "BP", which may be obtained through a pharmacy's wholesaler, that do not hold a marketing authorisation. These products are therefore unlicensed.

Unlicensed products have not been subject to tests of safety, quality and efficacy required for a marketing authorisation. Pharmacists will therefore be unable to rely on the marketing authorisation as a guarantee of quality of the product being supplied. Pharmacists should therefore check that products obtained from their wholesaler, intended for supply against a prescription, are appropriately licensed. A licensed medicinal product will have a marketing authorisation number on the label.

An unlicensed medicine should be considered for dispensing only where there is no licensed product available. The prescriber and the patient should be made aware of the unlicensed nature of the product.

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Over-packaging of Controlled Drugs

Pharmacists are reminded of the importance of supplying the exact amount of Controlled Drug when dispensing a prescription or when measuring ingredients with a view to preparing a mixture for stock.

Where the Controlled Drug is in the form of a powder, pharmacists are advised to weigh out the powder, rather than rely completely on the manufacturer's statement of quantity on the packaging, even if the amount stated on the manufacturer's container is the amount required. Similarly, when an original pack containing blister strips or loose tablets is required for dispensing, pharmacists are advised to count the individual tablets to ensure that the number of tablets stated on the manufacturers packaging is the same as the number of tablets contained within it.

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