Fed Regist. 1998 Jan 5;63(2):176-85.
The Food and Drug Administration (FDA) is proposing to amend its regulations to add certain labeling requirements concerning aluminum in large volume parenterals (LVP's) and small volume parenterals (SVP's) used in total parenteral nutrition (TPN). FDA is also proposing to specify an upper limit of aluminum permitted in LVP's and to require applicants to develop and to submit to FDA for approval validated assay methods for determining aluminum content in parenteral drug products. The agency is proposing these requirements because of evidence linking the use of parenteral drug products containing aluminum to morbidity and mortality among patients on TPN therapy, especially premature infants and patients with impaired kidney function.
美国食品药品监督管理局（FDA）提议修订其法规，以增加有关用于全胃肠外营养（TPN）的大容量胃肠外营养液（LVP）和小容量胃肠外营养液（SVP）中铝的某些标签要求。FDA还提议规定LVP中允许的铝的上限，并要求申请人开发并向FDA提交用于确定胃肠外药品中铝含量的经过验证的分析方法以供批准。该机构提出这些要求是因为有证据表明，使用含铝的胃肠外药品与接受TPN治疗的患者（尤其是早产儿和肾功能受损患者）的发病和死亡有关。
