title: Regulatory framework of pharmaceutical compounding and actual developments of legislation in Europe.
abstract: Pharmaceutical 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.
authors.affiliation: Department of Pharmaceutical Sciences, Università degli Studi di Milano, Via G. Colombo 71, 20133 Milan, Italy. Electronic address: paola.minghetti@unimi.it.
authors.forename: Paola
authors.initials: P
authors.lastname: Minghetti
authors.affiliation: Department of Pharmaceutical Sciences, Università degli Studi di Milano, Via G. Colombo 71, 20133 Milan, Italy. Electronic address: doriana.pantano@studenti.unimi.it.
authors.forename: Doriana
authors.initials: D
authors.lastname: Pantano
authors.affiliation: Department of Pharmaceutical Sciences, Università degli Studi di Milano, Via G. Colombo 71, 20133 Milan, Italy. Electronic address: chiara.gennari@unimi.it.
authors.forename: Chiara Grazia Milena
authors.initials: CG
authors.lastname: Gennari
authors.affiliation: Department of Pharmaceutical Sciences, Università degli Studi di Milano, Via G. Colombo 71, 20133 Milan, Italy. Electronic address: antonella.casiraghi@unimi.it.
authors.forename: Antonella
authors.initials: A
authors.lastname: Casiraghi
mesh_terms: D004339:Drug Compounding / Q000592:standards*; D005060:Europe; D033161:Government Regulation; D010594:Pharmacies / Q000331:legislation & jurisprudence* / Q000592:standards; D010595:Pharmacists; D011785:Quality Assurance, Health Care / Q000592:standards
keywords: Extemporaneous; Pharmaceutical preparations; Pharmacy compounding; Regulation; Resolution