La « préparation magistrale » en droit français : un lot exclusif par patient ?

Outpatient pharmaceutical needs are not always met by industrial products and do not necessarily justify hospitals activation. Preparing in advance and storing a batch of compounded drugs for one or more patients with identical/recurrent needs - as part of compound outsourcing in ambulatory sector - raises issues. While the french law does not expressly provide (and according to prevailing interpretations excludes) this hypothesis, it seems to us to be possible - in contrast to the prominent french judicial and administrative courts, as well as to the European Court of justice. We here propose to reset the debate within both the existing laws and a systemic perspective, and call for a normative clarification.