Abstract: Objective To provide reference to the management of validity periods of leftover medicines in medicine instructions in China.Methods Through searching the literatures, analyzing the regulations about medicine instructions and Chinese Pharmacopoeia, the problems of validity periods of leftover medicines were discussed, the solutions and recommendations were proposed.Results Most medicine instructions in our country do not provide the statements of validity periods of leftover medicines, which may influence public’s medication safety.Conclusion Validity periods of leftover medicines are closely associated with the public’s medication safety. It is necessary to strengthen the responsibility of drug manufacturers to improve the label contents of validity periods of remaining medicines further. It is suggested that drug regulatory authorities continue to improve the medicine instruction managements and provide scientific explanations and definitions on the validity periods of leftover medicines.

Key words: leftover medicine, medicine instruction, validity period, labeling problem