OBJECTIVE To explore and analyze the U.S drug traceability and security system. METHODS By researching domestic and foreign literature,this study analyzed the background of the U.S Drug Supply Chain Security Act,the key elements, characteristics and advantages of the drug traceability and security system, as well as problems and challenges. RESULTS Based on the complete information chain, whose core element is the product identifier, the U. S established a responsibility chain among trade parties for information transmission, verification and investigation of suspect product and disposition of illegitimate products. The system also designed a transition period of 10 years. To ensure drug safety, as well as protect and promote public health, FDA provides guidance and assistance to the industry, controls supply chain security through recalls and other measures, and supervises the trade parties. CONCLUSION The U.S drug traceability and security system can make legal products in the supply chain leave a trace during the whole process. With the transfer of drug ownership, the supply chain participants should take corresponding responsibilities. As a supervisor, FDA can take risk control measures according to the responsibility chain and take the blame. The responsibility of the U.S pharmaceutical supply chain is clear, and the participants work together to avoid the circulation of illegal products under the assistance and guidance of the FDA. The U.S drug traceability and security system is worth being referenced and learned in China.