Abstract: Off-label drug use is common and unavoidable in the clinical practice. However, there is still a lack of unified standardization among medical institutions on how to practice off-label drug use. In order to assist the medical institutions to standardize the off-label drug use, the Evidence-based Pharmacy Professional Committee of Guangxi Pharmaceutical Association organized 41 medical institutions and 114 experts in Guangxi Province to formulate this consensus after 5 rounds of discussion. This consensus and the first batch of off-label drug catalogs are based on a comprehensive assessment and screening of the level of evidence, clinical needs, and other factors. The development of this consensus will provide an evidence-based basis for the effectiveness and safety of off-label drug use, as well as a reference for protecting the legitimate rights and interests of doctors and patients and reducing the risk of practice.