Fed Regist. 2012 Jan 3;77(1):7-18.
The Food and Drug Administration (FDA) is revising the labeling requirements for blood and blood components intended for use in transfusion or for further manufacture by combining, simplifying, and updating specific regulations applicable to labeling and circulars of information. These requirements will facilitate the use of a labeling system using machine-readable information that would be acceptable as a replacement for the ``ABC Codabar'' system for the labeling of blood and blood components. FDA is taking this action as a part of its efforts to comprehensively review and, as necessary, revise its regulations, policies, guidances, and procedures related to the regulation of blood and blood components. This final rule is intended to help ensure the continued safety of the blood supply and facilitate consistency in labeling.
美国食品药品监督管理局（FDA）正在修订用于输血或通过合并、简化和更新适用于标签及信息通告的特定法规进行进一步制造的血液及血液成分的标签要求。这些要求将促进能够使用机器可读信息的标签系统的应用，该系统将可作为用于血液及血液成分标签标记的“ABC条码”系统的替代方案。FDA将此行动作为其全面审查并在必要时修订与血液及血液成分监管相关的法规、政策、指南和程序工作的一部分。本最终规则旨在帮助确保血液供应的持续安全，并促进标签的一致性。
