Recognition and Use of a Standard for Uniform Blood and Blood Component Container Labels Guidance for Industry April 2024

GUIDANCE DOCUMENT

• Docket Number: FDA-1998-D-0067
• Issued by: Center for Biologics Evaluation and Research

We, FDA, Center for Biologics Evaluation and Research (CBER), are recognizing as acceptable for use by you, manufacturers of blood and blood components, subject to United States statutes and regulations, the document entitled “United States Industry Consensus Standard for the Uniform Labeling of Blood and Blood Components Using ISBT 128,” Version 4.0.0, dated January 2024 (Version 4.0.0 Standard).  The Version 4.0.0 0 Standard is the revised version of the “United States Industry Consensus Standard for the Uniform Labeling of Blood and Blood Components Using ISBT 128,” Version 3.0.0, dated March 2013.  

The Version 4.0.0 Standard describes a system of uniform container labels for blood and blood components intended for transfusion or for further manufacturing use.  We believe that this uniform container label standard will assist manufacturers in complying with the container label requirements under Title 21 of the Code of Federal Regulations 606.121 (21 CFR 606.121).  This guidance supersedes the guidance of the same title dated June 2014.

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