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《药品管理法》第四章对医疗单位的药剂管理做了明确的法律规定。第十七条规定:医疗单位配制制剂必须经所在省、自治区、直辖市卫生行政部门审查批准,并发给《制剂许可证》。一、核发《制剂许可证》核发医疗单位制剂许可证的程序是:由本单位提出申请,经当地卫生行政部门审核同意,然后上报所在省、自治区、直辖市卫生行政部门,按规定的条件经检查验收合格者,可发给《制剂许可证》。该证要注明配制制剂的范围及有效日期,到期重新审查,合格者重新发给或延期使用;不合格者吊
Chapter 4 of the Drug Administration Law makes explicit legal provisions on the administration of pharmaceuticals by medical units. Article 17 stipulates that preparations formulated by medical units must be examined and approved by the health administrative department of the province, autonomous region or municipality directly under the Central Government and be issued with a “preparation license.” First, the issuance of “preparation permit” issued by the medical unit preparation permit program is: by the unit to apply for approval by the local health administrative department approval, and then reported to the provinces, autonomous regions and municipalities directly under the Central Government, according to the conditions of the inspection and acceptance Passers-by can be issued “preparation permit.” The certificate should indicate the scope and expiration date of preparation of the preparation, to re-examine the expiration of the pass, re-issue or postpone the use of eligible;