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《药品管理法》第七条明文规定,“生产药品所需的原料、辅料以及直接接触药品的容器和包装材料,必须符合药用要求”。这个规定,当然应是医院配制制剂必须遵循的原则。但是,真正要完全达到这些要求,在具体执行中,还存在着一些问题。几年来,笔者在一些地、市、县医疗单位所见,医院制剂使用非药用规格的原辅料的情况是带有普遍性的问题,现提出与同行们讨论。1 化学试剂等非药用原辅料用于制剂的问题早在六十年代初期,因武汉某厂生产的化学试剂氯化钾发生死亡事故,中央五部联合发出通知,严格禁止将化试作为药用以后,几乎所有厂家和医
Article 7 of the Drug Administration Law expressly stipulates that “the raw materials and auxiliary materials required for the production of pharmaceutical products and the containers and packaging materials in direct contact with the pharmaceutical products must meet the requirements for pharmaceutical use.” This provision should, of course, be the principle that hospitals must follow to formulate. However, if we really want to completely meet these requirements, there are still some problems in the specific implementation. Over the past few years, I see in some places, cities and counties medical units, the use of non-pharmaceutical specifications of the hospital preparations of raw materials is a common problem, it is proposed to discuss with colleagues. A chemical reagents and other non-pharmaceutical raw materials used in the formulation of the problem As early as the early 1960s, due to a factory in Wuhan chemical reagents potassium chloride death, the central five jointly issued a notice, the test ban as a drug After use, almost all manufacturers and doctors