United States Industry Consensus Standard for the Uniform Labeling of Blood and Blood Components Using ISBT 128; Availability

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The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``United States Industry Consensus Standard for the Uniform Labeling of Blood and Blood Components Using ISBT 128,'' December 1997. The International Council for Commonality in Blood Banking Automation (ICCBBA) has submitted the draft document to FDA with a recommendation that it serve as the basis for current FDA guidance on the labeling of blood and blood components. The ICCBBA recommends that the bar coding system described in the draft document, ``ISBT 128,'' replace the coding system ``ABC Codabar'' currently in use for blood and blood components. FDA is considering updating its guidance on blood labeling and is issuing this notice to invite public comment on the ICCBBA's draft document and the ``ISBT 128'' coding system, as well as issues related to the possible transition from the labeling of blood and blood components using the ``ABC Codabar'' to a new coding system.