美国食品和药品管理局（FDA）于2013年4月发布了“为把用药错误降到最低，容器标签和纸盒标识设计考虑的安全性问题”的指导原则（草案）。针对处方药提出了一整套建议，包括一般原则和具体的建议。我国尚无这类指导原则。综述了FDA该指导原则的内容，期望有利于提高我国药品标签和标识的质量并增强其监管工作，有益于确保用药者的安全。

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.