OBJECTIVE： To promote the normative management of clinical off-label drug use. METHODS： The degree of deviation from the drug instructions and the risk degree were comprehensively considered， and the off-label drug use were classified into three different situations for classifying approval and informed consent classifying； situation and effects after classifying were evaluated. RESULTS： The classifying included occasional or small amount off-label use on dosage and drugs solvent （the first）， regular off-label use on route or administration （the second） and super-indications drug use with contraindications （the third）. The approval was classified as follows as confirmed with signature by doctor， approved by medical department， approved by pharmaceutical committee and ethics committee accordingly； informed consent classifying were signing informed consent， informing and recording in medical record， informing orally. Off-label drug use approval process was officially initiated from Feb. 2014 to Jun. 2016 in our hospital， 51 off-label drug use applications from 13 clinical departments were received， with 16 items belonging to the second situation， 35 items belonging to the third. Finally 42 applications were approved and 9 were not. No relevant new/serious adverse drug reactions / events occurred in process of the approved off-label drug use. And no off-label drug use not approved was found to continue to be used in our hospital. CONCLUSIONS： Classification management methods for off-label drug use in our hospital have shown high operability， improved the off-label drug use behavior of physicians.