OBJECTIVE： To investigate off-indication use of oral chemical drugs medical orders by the standards of CFDA and FDA， and to compare the differences between the two standards， analyze reasons and rationality of drug use， so as to provide reference for establishing off-indications use management system. METHODS： The oral chemical drugs medical orders of inpatients were analyzed statistically during Jan.-Jun. 2016. Off-label uses was judged according to the standards of CFDA and FDA. RESULTS： Totally 507 oral chemical drugs medical orders were collected， the percentage of off-indications use were in high level， being 58.58％ and 55.82％ respectively by the standards of CFDA and FDA. The incidence of off-indication use of quetiapine and aripiprazole by the CFDA standards were significantly higher than the results of FDA standards， with statistical significance （P＜0.05）. Magnesium valproate （54.03％）， escitalopram oxalate （10.45％） and quetiapine （10.15％） occupied the top 3 places in the list of constituent ratio. Among off-indication medical orders， 7 orders had no evidence-based medicine， accounting for 2.36％ of total. CONCLUSIONS：  Most off-indication medical orders of our hospital could provide the basis and literature support， while there are still a few off-indication use with insufficient evidence. The corresponding management system of the hospital should be formulated to guarantee the medication safety of the patients and legitimate rights and interests of the doctors.