关键词: 使用期限, 有效期, 稳定性, 多剂量包装药品, 临用现配药品, 重新包装药品, 药物配制

Abstract: Objective To review the related concepts and regulations for in-use period in China and abroad in order to propose references and suggestions for the improvement of in-use period management of medicinal products in China. Methods By literature retrieval, the related concepts and regulations for in-use period in China and abroad were introduced and classified. The differences between shelf life and in-use period were compared and analyzed. Results and Conclusion Compared with the concept of shelf life, the concept of in-use period is different in stability study type, assigning person, starting time and marking method. By now, the regulations for in-use period in China are insufficient. By contrast, international regulations for in-use period are relatively systematic, which include multi-dose packaging drugs after the first time of being opened, drugs after reconstitution or dilution, repackaged drugs and pharmaceutical compoundings. International regulations for in-use period provide beneficial references and enlightenments for the improvement of in-use period management of medicinal products in China.

Key words: in-use period, shelf life, stability, multi-dose packaging drug, drug after reconstitution or dilution, repackaged drug, pharmaceutical compounding