Definition
Galenic preparations are prepared by the pharmacist in the laboratory of the pharmacy, whether territorial or hospital. They are classified in the primary legislation and in the glossary to the Norme di Buona Preparazione della Farmacopea Ufficiale della Repubblica Italiana (FU) into two categories: magistral preparations and officinal preparations.
– Magistral formula/preparation: the medicinal product prepared in a pharmacy on the basis of a medical prescription for a specific patient; all mixtures, dilutions, distributions, etc., carried out for the individual patient on the basis of a medical indication (when necessary, this must be drawn up in accordance with L. 94/98) are also technically assimilated to magistral preparations.
– Officinal formula/preparation: a medicinal product prepared in a pharmacy in accordance with the indications of an EU pharmacopoeia and intended to be supplied directly to patients using that pharmacy. In the Farmacopea Ufficiale della Repubblica Italiana (FU), officinal preparations are included in the chapter of Monographs as ‘Monographs of specific pharmaceutical preparations’.
For procedures and fulfilments in the preparation of galenic preparations, please refer to the Good Manufacturing Practice.
References
Synonyms
English
Pharmacy preparations/compounding (magistral and officinal formula)
