Abstract: OBJECTIVE To interpret the legal attributes of off-label use, promote the standardization and legality of off-label use. METHODS By analyzing the drug registration process, the legal status of off-label use was clarified. According to the basic principles of civil law and relevant legal provisions, the legality of off-label use was defined. The recommendation level and legal effect evaluation of the off-label use management strategy reported in the current literature were made, and then suggestions were put forward. RESULTS The package insert was not a normative legal document, and its legal effect was only a reference for clinical use of medical personnel. The off-label use behavior didn't violate Chinese laws, but its legitimacy still lack consensus of insides and outsides. In response to risks, some scholars had recommended and adopted a range of countermeasures. Due to clinical practice and legal effects, some of them were open to question. CONCLUSION In order to circumvent the practice risks, combined with China's national conditions, it is recommended to explore an efficient communication mechanism for doctors and patients, call on the government to continuously improve the drug regulatory system and request the Supreme People's Court to release guiding cases, for the recertification of reasonable off-label use.