美国重新包装药品有效期执法政策及对我国的启示

Compliance Policy for Expiration Date of Repackaged Drugs in America and Its Enlightenments for China

目的:为规范我国拆零药品有效期管理提供参考和建议。方法:通过概述美国重新包装药品有效期执法政策的主要内容,分析我国拆零药品有效期管理的现状和问题,提出规范我国拆零药品有效期管理的建议。结果与结论:美国重新包装药品有效期执法政策包含了重新包装药品有效期的确定原则和重新包装容器标准等方面的内容。而目前我国对拆零药品有效期管理缺乏具体标准和要求,主要存在拆零药品有效期概念不明确和包装容器管理不规范等问题。笔者建议相关部门可借鉴美国重新包装药品有效期执法政策,明确拆零药品有效期的确定方法,规范拆零药品包装容器的标准和管理,以切实规范我国拆零药品有效期管理。

OBJECTIVE： To provide references and suggestions for expiration date management of dismounted drugs in China. METHODS： The main contents about compliance policy for expiration date of repackaged drugs in America were summarized. The current situation and problems of expiration date management of dismounted drugs in China were analyzed to provide suggestions for standardizing expiration date management of dismounted drugs in China. RESULTS ＆ CONCLUSIONS： The compliance policy for expiration date of repackaged drugs in America contain determination principle of expiration date of repackaged drugs, repackaged container standard, etc. In contrast, the expiration date management of dismounted drugs in China is lack of specific standards and requirements; major issues are as follows as the concept of expiration date of dismounted drugs is ambiguous and container management is not standardized. It is suggested that relevant departments can refer to compliance policy for expiration date of re-packaged drugs in America, define the method of determining the expiration date of the dismounted drugs, and standardize the standards and management of packaging containers so as to standardize expiration date management of dismounted drugs in China practically.