Regulatory Focus™ > News Articles > Revisions to Labeling Requirements for Blood Products Coming in July 2012

Revisions to Labeling Requirements for Blood Products Coming in July 2012

Posted 03 January 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) is preparing to release revisions to their labeling requirements for blood and blood components, including source plasma, in July of 2012 according to a 3 January posting in the Federal Register.

The rule will transition the system to one that uses machine-readable information that will act as a replacement for the "ABC Codabar" system that presently exists.  The final rule will also consolidate most of the labeling requirements for blood products in to a single section of the Code of Federal Regulations (CFR).

The replacement for the current ABC Codabar system comes from the International Council for Commonality in Blood banking Automation (ICCBBA), and is known as International Society of Blood Transfusion Code 128 (ISBT 128).

The final rule will:

  • finalize labeling requirements for blood and blood components intended for use in transfusion or other manufacture;
  • eliminate inconsistencies between prior versions of the ISBT standard ;
  • facilitate the use of a labeling system using machine-readable information;
  • facilitate the use of future labeling systems not yet under development;
  • consolidate regulations in the CFR so that blood labeling requirements now reside in 21 CFR 606.121; and
  • make a number of smaller changes, including re-titling certain sections and replacing "shall" with "must" in all areas of the rule.


The rule has been under development since 1995, when the FDA determined that the ABC Codabar system was becoming outdated. 

The rule will become effective on 2 July, 2012.

(Federal Register - Revisions to Labeling Requirements for Blood and Blood Components, Including Source Plasma)


Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe