FDA is issuing this guidance for immediate implementation in accordance with 21 CFR 10.115(g)(4)(i).
The Center for Biologics Evaluation and Research (CBER), is recognizing as acceptable for use by 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 containerlabels for blood and blood components intended for transfusion or for further manufacturing use.
The CBER believes 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.
Under 21 CFR 606.121(c)(13), the container label of blood or blood components intended for transfusion must bear encoded information in a format that is machine-readable and approved for use by the Director, CBER.
The Director of CBER has reviewed the Version 4.0.0 Standard, dated January 2024, and finds it acceptable for use on the container labels of blood or blood components.
