Community and hospital pharmacists are to be required to keep records of "specials" that they have supplied to patients for five years. Specials are unlicensed medicines that have been manufactured for specific patients to meet a special need.
The requirement is contained in updated guidance on the manufacture and supply of specials issued by the Medicines Control Agency in February. The guidance says that any person who supplies a special must keep for five years a record of the source of the product, the person to whom it was supplied and the date, the quantity, the batch number and details of any adverse reactions of which he is made aware. These records have to be kept available for inspection by the licensing authority. There is also a requirement to report any serious adverse drug reactions using the yellow card scheme.
After taking legal advice, the MCA has taken the view that specials may only be supplied in order to meet a special patient need, such as intolerance or allergy to an ingredient in a licensed product or inability to swallow a licensed solid dosage form.

New guidance on the manufacture and supply of "Specials" has been produced by the Medicines Control Agency