医疗机构自配制剂,是指那些在市场上没有供应的,而医院临床又非常需要,同时又经过当地药品管理部门批准,仅供本单位使用的药品。2005年8月1日起,国家食品药品监督管理局颁布的《医疗机构制剂注册管理办法》(试行)正式实施。《办法》对医院制剂的要求与过去不同,对医院制剂的发? The medical institution’s self-formulation refers to those drugs that have not been supplied in the market, and the hospital is in great need of clinical practice, and has been approved by the local drug administration department and used only for the drugs used by the unit. On August 1, 2005, the Administrative Measures for Registration of Medical Institutions (Trial Implementation) promulgated by the State Food and Drug Administration was formally implemented. The requirements of the “Measures” for hospital preparations are different from those in the past and the development of hospital preparations.