2015年2月FDA發(fā)布了"藥物配制外包設(shè)施公司依據(jù)FD&C Act 503B的不良事件報(bào)告的指導(dǎo)原則(草案)"."藥物配制外包設(shè)施公司"是指在一個(gè)地理位置或地址,從事配制無菌藥品的外包設(shè)施機(jī)構(gòu)而且已注冊(cè)為外包設(shè)施公司并且遵守FD&C Act 503B的所有要求."配制"是指執(zhí)業(yè)藥師、執(zhí)業(yè)醫(yī)師或在外包設(shè)施公司內(nèi)在執(zhí)業(yè)藥師監(jiān)督下的人,根據(jù)患者個(gè)體需要,組合、混合或改變藥物成分,創(chuàng)制藥物制劑的過程.介紹該指導(dǎo)原則的主要內(nèi)容,期待對(duì)我國醫(yī)療機(jī)構(gòu)配制制劑的不良事件報(bào)告及其監(jiān)管有所啟發(fā).

FDA issued "Adverse Event Reporting for Outsourcing Facilities Under Section 503B 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 503B. "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.