The Pharmaceutical Journal
Vol 269 No 7214 p312
7 September 2002

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Exemption for pharmacists from new specials rules

Pharmacists working in registered pharmacies are to be exempt from new regulations on the manufacture of unlicensed medicines.

Proposed rules, set out in MLX 280 on which the Medicines Control Agency is currently consulting, are intended to bring unlicensed medicines under the scope of European guidelines intended to minimise the risk of transmitting animal encephalopathy agents to people via medicines. Currently the guidance applies only to licensed medicines.

Pharmacists are to be exempt from the rules, which will be enforceable under the Consumer Protection Act 1987, because the MCA believes that existing professional arrangements are sufficient to ensure safety. The professional arrangements are set out in the Royal Pharmaceutical Society's Code of Ethics, which says that ingredients must be of a quality accepted for use in the preparation and manufacture of pharmaceutical products and that pharmacists must not buy products where they have any reason to doubt their quality or safety — Part 3: Service Specifications; 2 Stock (a) and 21 Extemporaneous preparation/compounding (d).

Under the proposed new rules, specials manufacturers and anyone else preparing medicines which are exempt from licensing requirements (except herbal remedies) will have to produce evidence within 21 days of a request from the Secretary of State for Health that any materials of animal origin comply with the European TSE (transmissable spongiform encephalopathy) guidelines. Failure to produce satisfactory evidence may lead to prohibition of the product concerned or prosecution.

Stephen Lutener, head of professional conduct at the Royal Pharmaceutical Society said: "If, as a result of the consultation, products prepared by or under the supervision of a pharmacist remain excluded medicines, then guidance will be issued to pharmacists by the Professional Standards Directorate."

MLX 280 is available on the internet at www.mca.gov.uk.