Answer

 
  • 21 CFR 606.121(c)(13)(ii-iii) states the container label must bear encoded information in a format that is machine-readable and approved for use by the Director, Center for Biologics Evaluation and Research.

 

  • Currently, two types of machine-readable label types are recognized by FDA: FDA recognized the use of Codabar (a specific bar code symbology) in 1985; and FDA accepted the use of ISBT 128, version 1.2.0, in 2000. CBER has recognized the second version (2.0.0.) effective September 22, 2006. Please see our latest Guidance on this: http://www.fda.gov/cber/gdlns/unilabbld.htm as well as the new ISBT 128 Uniform Labeling document: http://www.fda.gov/cber/gdlns/ISBT128.pdf.

 

 

  • Each label must have at a minimum: (A) A unique facility identifier; (B) Lot number relating to the donor; (C) Product code; and, (D) ABO and Rh of the donor.

Last revised: March 28, 2007