Shirk M B, Hale K N
Department of Pharmacy, Ohio State University Hospitals, Columbus 43210.
Am J Hosp Pharm. 1992 Nov;49(11):2731-9.
Guidelines are presented for pharmacist coordination of the importation for use by institutionalized patients of drugs not currently approved by the FDA. A prerequisite for importation of foreign drugs is that traditional therapies have failed or are not an option. Steps that are required for drug importation and administration include completing an investigational new-drug application, obtaining institutional review board approval, obtaining informed consent, contacting a customs broker or the local FDA district import program manager, arranging for drug shipment, and documenting receipt and administration of the drug. Conditions are described under which portions of this process may be waived. By helping to ensure compliance with FDA requirements, pharmacists can expedite drug importation for institutionalized patients.
本文给出了药师协调进口未获美国食品药品监督管理局（FDA）批准、供机构化患者使用的药品的指导原则。进口国外药品的一个前提条件是传统治疗方法已失败或不可行。药品进口和给药所需步骤包括完成一份研究性新药申请、获得机构审查委员会批准、获得知情同意、联系报关行或当地FDA地区进口项目经理、安排药品运输以及记录药品的接收和使用情况。文中描述了该过程部分环节可被豁免的条件。通过帮助确保符合FDA要求，药师可以加快为机构化患者进口药品的进程。
