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The preparation of medicines in pharmacies is essential for accommodating the individual needs and medical conditions of patients in Europe and beyond. This article describes the state of pharmacy preparation in preparing and distributing pharmacies (PDPs) in the Netherlands. The Medicines Act in the Netherlands is based on the European Union Directive 2001/83/EC, which forbids a PDP from preparing and distributing unlicensed medicinal products to dispensing pharmacies. In order not to obstruct patient care, the Dutch Inspectorate has sent a Circular Letter on large-scale preparation to all Dutch pharmacists. This Circular describes the qualitative conditions that must be fulfilled by the PDPs. The aim of this study was to assess the overall compliance of Dutch PDPs with the conditions of the Circular. These conditions are: an absence of licensed pharmacotherapeutic alternatives, rational pharmacotherapy, a product dossier for all products and compliance with Good Manufacturing Practice (GMP).

Inspectorate surveillance of preparing and distributing pharmacies in The Netherlands