FDA对药物配制外包设施公司不良事件报告的要求

FDA's requirements for adverse event reporting of outsourcing facility

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。

FDA issued 'Adverse Event Reporting for Outsourcing Facilities Under Section 503 B of the FD&C Act Guidance for Industry(Draft)' in February 2015. 'Outsourcing facility' is a facility at one geographic location or address that is engaged in the compounding of sterile drugs, has elected to register as an outsourcing facility, and complies with all of the requirements of section 503 B. 'Compounding' refers to a practice in which a licensed pharmacist, a licensed physician, or, in the case of an outsourcing facility, a person under the supervision of a licensed pharmacist, combines, mixes, or alters ingredients of a drug to create a medication tailored to the needs of an individual patient. This paper introduces the main contents of the guidance, looking for inspiration to adverse event reporting of medical institution preparation and its regulation in our country.