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Journal de Pharmacie Clinique

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Searching for active ingredients when “lacking available or adapted medicinal products” for hospital preparations – French legal framework Volume 25, issue 1, Janvier-Février-Mars 2006

Author
MCU, service de droit et d’économie de la santé, Faculté de pharmacie de Paris V

The limits of the industrial offer regarding drugs lead the hospital pharmacist to preparations manufacturing containing active ingredients or incorporating medicinal products. The national regulations bring various answers to the clinical and legal problems induced. In France, the applicable regulation to the hospitals shows that, in spite of restrictive interpretations, incorporating medicinal products in a preparation rely on the control of the risks, the deadlines and the costs, and not on the impossibility of getting bulk active ingredients. Thus, a systematic collection of local experiences and the mutualisation of feasibility studies will offer a relevant technical support to the clinical pharmacist.