Fed Regist. 2006 Jan 24;71(15):3921-97.
The Food and Drug Administration (FDA) is amending its regulations governing the content and format of labeling for human prescription drug products (including biological products that are regulated as drugs). The final rule revises current regulations to require that the labeling of new and recently approved products include highlights of prescribing information and a table of contents. The final rule also reorders certain sections, requires minor content changes, and sets minimum graphical requirements. These revisions will make it easier for health care practitioners to access, read, and use information in prescription drug labeling. The revisions will enhance the safe and effective use of prescription drug products and reduce the number of adverse reactions resulting from medication errors due to misunderstood or incorrectly applied drug information. For both new and recently approved products and older products, the final rule requires that all FDA-approved patient labeling be reprinted with or accompany the labeling. The final rule also revises current regulations for prescription drug labeling of older products by clarifying certain requirements. These changes will make the labeling for older products more informative for health care practitioners.
美国食品药品监督管理局（FDA）正在修订其关于人类处方药产品（包括作为药品监管的生物制品）标签内容和格式的法规。最终规则修订了现行法规，要求新的和最近批准的产品标签包括处方信息要点和目录。最终规则还重新排列了某些章节，要求进行少量内容更改，并设定了最低图形要求。这些修订将使医疗保健从业者更容易获取、阅读和使用处方药标签中的信息。这些修订将加强处方药产品的安全有效使用，并减少因误解或错误应用药物信息导致用药错误而产生的不良反应数量。对于新的和最近批准的产品以及旧产品，最终规则要求所有经FDA批准的患者标签随标签一起重新印刷或附上。最终规则还通过澄清某些要求来修订旧产品处方药标签的现行法规。这些更改将使旧产品的标签对医疗保健从业者更具信息性。
