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《中华人民共和国药品管理法实施办法》(以下简称《实施办法》)是在总结我国三年多来按照《中华人民共和国药品管理法》对药品实行监督管理的实践基础上,针对执法中碰到的一些问题而制订的更为具体而明确的法定细则。它适用于所有药品生产、经营、使用、检验、科研单位和个人,具有指导和法律的约束作用。它是监督管理工作的法律武器。然而贯彻施行《实施办法》半年多来,还存在很多问题,其中医院制剂就是尚需解决的问题之一,据笔者了解,目前许多医院制剂室均存在着以下几个问题:
The “Measures for the Implementation of the Drug Administration Law of the People’s Republic of China” (hereinafter referred to as the “Implementation Measures”) is based on the practice of supervising and administering drugs in accordance with the “Drug Administration Law of the People’s Republic of China” over the past three years or more. Some of the issues were formulated with more specific and clear statutory rules. It applies to all pharmaceutical production, operation, use, inspection, scientific research units and individuals, with guidance and legal constraints. It is a legal weapon for supervision and management work. However, there are still many problems in the implementation of the “Implementation Measures” for more than half a year. Among them, hospital preparations are one of the problems that need to be solved. According to the author’s understanding, many hospital preparation rooms currently have the following problems: