案例综述医院制剂,即在一定临床经验方的基础上的协定处方,申报省级药品监督部门批准仅供院内使用的制剂,包括法定制剂与非法定制剂。我国修改完善后重新颁布的《药品管理法》对医院制剂的管理提出了非常严格的要求,目的是保证医院制剂的质量,保障人民群众用药安全。作为药品监 Case Summary Hospital preparations, that is, prescriptions based on the agreement of certain clinical trials, shall be submitted to the provincial pharmaceutical supervision department for approval of preparations for in-hospital use only, including statutory and non-statutory preparations. The amended Drug Administration Law of China, after its amendment and reformation, promulgated very strict requirements on the management of hospital preparations in order to ensure the quality of hospital preparations and ensure the safety of drug users. As a drug regulator