Vaccines, Blood & Biologics
International Society of Blood Transfusion (ISBT)
Except where inconsistent with the regulations, FDA recognizes as acceptable the "United States Industry Consensus Standard for the Uniform Labeling of Blood and Blood Components Using ISBT 128" Version 2.0.0, dated November 2005, for container labels of blood and blood components intended for transfusion or for further manufacturing use. Any modifications to the Version 2.0.0 Standard are not recognized by FDA as acceptable for use until reviewed and found acceptable by the Director, CBER, and then issued as guidance. However, minor modifications to the Version 2.0 0 Standard document (e.g., 2.0.1, 2.0.2, 2.2, or 2.3, etc.) made to correct spelling or format errors in the document itself would be acceptable, and would not require review and acceptance by the Director, CBER.