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2015年2月FDA发布了“药物配制外包设施公司依据FD&C Act 503B的不良事件报告的指导原则(草案)”。“药物配制外包设施公司”是指在一个地理位置或地址,从事配制无菌药品的外包设施机构而且已注册为外包设施公司并且遵守FD&C Act 503B的所有要求。“配制”是指执业药师、执业医师或在外包设施公司内在执业药师监督下的人,根据患者个体需要,组合、混合或改变药物成分,创制药物制剂的过程。介绍该指导原则的主要内容,期待对我国医疗机构配制制剂的不良事件报告及其监管有所启发。
In February 2015, the FDA released the “Guiding Principles (Draft)” for Pharmaceutical Ingredient Outsourcing Companies under the FD & C Act 503B. “Pharmaceuticals Outsourcing Facilities Company” means all outsourcing facilities that make sterile pharmaceuticals in a single geographic location or address and have been registered as outsourced facility companies and comply with all FD & C Act 503B requirements. “Formulation” means the process by which a licensed pharmacist, a practicing physician, or a person under the supervision of a practicing pharmacist at an outsourced facility company, to create, combine, mix or alter the composition of a drug according to the needs of the individual patient. The main content of this guideline is introduced, and it is expected to give some inspiration to the reports and supervision of the adverse events formulated by medical institutions in our country.