• Paola Minghetti, Doriana Pantano, Chiara Grazia Milena Gennari, and Antonella Casiraghi.
• Department of Pharmaceutical Sciences, Università degli Studi di Milano, Via G. Colombo 71, 20133 Milan, Italy. Electronic address: paola.minghetti@unimi.it.
• Health Policy. 2014 Sep 1; 117 (3): 328-33.

AbstractPharmaceutical preparations are medicines that the pharmacist makes for the special needs of the patients that the pharmaceutical industry cannot comply for economic and logistic reasons. Pharmacy compounding is still an important component of pharmacy practice and a valuable therapeutical service that is an integrant part of the modern health care system, but its legislation is not harmonized among European and US countries. In 2011 the Committee of Ministers of the Council of Europe has adopted a Resolution on quality and safety assurance requirements for medicinal products prepared in pharmacies for the special needs of patients. Aim of this resolution is to harmonize quality assurance and standards for pharmacy-made medicinal products among European countries and to pass the gap in quality assurance and standards between preparation in pharmacies and medicines prepared by the pharmaceutical industry. This article will analyze the actual rules and technical norms that regulate compounding activity and the expectations resultants from the new European and US laws. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

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