In May 2002, a centralized Unit for cytotoxic drug preparations [Unità Farmaci Antiblastici (UFA)] was established at the Centro di Riferimento Oncologico, Aviano, Italy. The Unit was created following provisions under Low 626/94 /Legislative Decree - Ministry of Health), governing the safe handling of cytotoxic drugs. new guidelines governing drug preparation published in Italian Pharmacopoeia (2002, XI Edition) have been mandatory since 2004 and set out rules for proper pharmacy practice applicable also to antineoplastic drug preparations. The aim of this study is to assess UFA compliace with current legislation, and the appropriateness of methodology, equipment and operating procedures.