An Outlook on the European and Italian Rules to Guarantee Magistral Formulas
Author(s): Selmin Francesca, Casiraghi Antonella, Musazzi Umberto M, Fortini Marco, Minghetti Paola
Issue: Jan/Feb 2019 - Volume 23, Number 1
View All Articles in Issue
Page(s): 6-12
Download in electronic PDF format for $75
Abstract: Pharmaceutical compounded medicinal preparations are aimed to fulfill the special needs of a subpopulation of patients for whom a medicinal product is not commercially available. Nowadays, this activity remains an important component of pharmacy practice and an integral part of the modern healthcare system. In 2011, the Committee of Ministers of the Council of Europe adopted a resolution to harmonize quality assurance and safety standards for medicinal products prepared in pharmacies for the special needs of patients in European countries. This article discusses the actual rules and technical norms that regulate the compounding activity in Italy in the light of the new European laws.
Related Keywords: European Union, pharmacy regulations, Council Directives, European Pharmacopeia, quality assurance, drug safety, international drug standards, drug labeling, Italy, Italian Society of Compounding Pharmacists, SIFAP, risk assessment, Guide to Good Practices for the Preparation of Medicinal Products in Healthcare Establishments, Good Compounding Practices