當藥廠製造藥品無法滿足臨床上的特殊醫療需求時，藉由藥學專業知識與調製技能，為病人調製藥品，一直是藥師的重要業務。本文回顧歐盟近年逐漸發展的調製藥品作業規範，期能做為未來國內相關法規制定的參考；希望藉由適當的法規規範以及藥師的專業知識，確保調製藥品的品質以維護用藥安全，並滿足日益複雜的臨床醫療需求。

Some special needs of patients could not be met by the commercially available medical products,compounding is an important practice of pharmacists because of their pharmaceutical knowledge and preparation skills. We reviewed the related laws and regulations of European Union developed in recent years in order to formulate a proposal for the regulations in Taiwan. Through appropriate regulations and pharmaceutical knowledge, the quality and safety of hospital pharmacy compounding can be ensured, and these compounding can fulfill the special medical needs for many patients.