美國食品和藥品管理局（FDA）于2013年4月發(fā)布了“為把用藥錯誤降到最低，容器標(biāo)簽和紙盒標(biāo)識設(shè)計考慮的安全性問題”的指導(dǎo)原則（草案）。針對處方藥提出了一整套建議，包括一般原則和具體的建議。我國尚無這類指導(dǎo)原則。綜述了FDA該指導(dǎo)原則的內(nèi)容，期望有利于提高我國藥品標(biāo)簽和標(biāo)識的質(zhì)量并增強其監(jiān)管工作，有益于確保用藥者的安全。

FDA issued “Guidance For Industry — Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors (Draft)” in April of 2013. For prescription drugs, a set of recommendations, including the general principles and specific recommendations, were provided. There is no still such guidance in China. This paper introduces the main contents of the guidance of FDA. It is expected to help to improve the quality of drug labels and labeling and to strengthen the supervision work in our country, especially to be beneficial to ensure the safety of drug users.