On 10 May 2015, the Italian Society of Compounding Pharmacists (Società Italiana Farmacisti Preparatori – “SIFAP”) adopted a Position Paper on so-called “magistral formulas” (i.e., medicines created by pharmacists based on the indications of the treating physician and intended for the treatment of a specific patient).

Community and national law on the quality and safety of magistral formulas provides that, before preparing a compound, the pharmacist must verify the real clinical needs of the patient in relation to the risk connected to the preparation, and evaluate whether it is more risky to leave the patient without therapy rather than providing recourse to a compound made without the strict procedures for medicines of industrial origin. In particular, the law in effect establishes that, should there be available an appropriate pharmaceutical equivalent, the pharmacist, before compounding the medicine, must inform the treating physician and discuss with him to ascertain the real necessity of preparing the compound.

The aim of the SIFAP Position Paper is to provide the preparing pharmacist an effective tool for evaluating if the requested compound presents an “added value” and the preparation of the magistral medicine is therefore necessary in accordance with applicable national and Community law.