Recent changes in UK legislation and the licensing of radiopharmacies.

The implications of the recent loss of Crown Immunity to radiopharmacy in the NHS are reviewed. The options available are that the preparation of radiopharmaceuticals within a hospital will either be under the control of a pharmacist or be an activity licensed as 'Specials' manufacture. In the latter case the requirements for inspection by the Medicines Control Agency, the fees payable and the need for involvement of a pharmacist are reviewed. The requirements for the grant of a Specials Manufacturing Licence are presented in some detail. Reference is made to established and published sources of guidance, official and otherwise. Consideration is given to: staffing and personnel, open and closed procedures, environmental standards, handling of blood products, use of isolators, quality control and quality assurance, licensed and unlicensed materials, sterility testing, broth transfer tests, environmental monitoring and documentation.