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根据《药品管理法》第四章的规定和《药品管理法实施办法》第三章、第八章的规定,制定本验收标准.一、配制制剂的性质和范围1.医疗单位配制的制剂,只限于本单位临床和科研需要而市场上无供应或供应不足的药物制剂.自制制剂凭医生处方使用,不得流入市场销售.2.配制制剂应按国家药品标准和地方药品标准及卫生行政部门颁布的制剂规范等进行配制.
According to the “Drug Administration Law” Chapter IV and “Drug Administration Law Implementation Measures” Chapter III, Chapter VIII of this acceptance criteria for the development of a preparation of the nature and scope of the preparation of a medical unit preparation, Confined to the clinical and scientific research needs of the unit while the market is not available or insufficient supply of pharmaceutical preparations. Homemade preparations with the doctor’s prescription use shall not flow into the market .2 preparation of formulations should be in accordance with national drug standards and local drug standards and health administration promulgated Formulation specifications and the like.