[目的]介绍美国对于药品标签外促销的监管。[方法]通过中外文献的检索,介绍美国标签外用药的定义、类型、法律适用、注册与监管、补偿机制等,旨在使读者对于美国的标签外用药监管政策有个初步的了解。[结果与结论]标签外用药应该存在并得到发展的支持,但对此应予以严格监控。 [Objective] To introduce the regulation of the United States for the promotion of drug labeling. [Methods] Through the retrieval of Chinese and foreign literatures, this paper introduces the definition, types, applicable law, registration and supervision, compensation mechanism and so on of US external label drugs so as to make the readers have a preliminary understanding of the US external label regulatory policy. [Results and Conclusions] The use of external labels should exist and be supported by the development, but this should be strictly monitored.