Fast-breaking News from AABB PulsePoints The following has been reproduced from the September 22, 2006 AABB PulsePoints, an electronic news alert provided by the American Association of Blood Banks.

September 22, 2006
No. 751

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

AABB PulsePoints

The Food and Drug Administration (FDA) released guidance on Sept. 22, 2006, that recognizes an updated ISBT 128 standard. Intended for immediate implementation, “United States Industry Consensus Standard for the Uniform Labeling of Blood and Blood Components Using ISBT 128,” Version 2.0.0, dated November 2005, applies to container labels of blood and blood components intended for transfusion or for further manufacturing use. This revised guidance document is relevant in all cases except those in which ISBT is inconsistent with the regulations.

Under 21 CFR 606.121(c)(13), the container label for blood and blood components intended for transfusion must have encoded information in a format that is machine-readable and approved for use by the director of the Center for Biologics Evaluation and Research (CBER). The director of CBER has reviewed the information regarding the Version 2.0.0 standard and found it acceptable for use on the container labels of blood and blood components intended for transfusion or for further manufacturing use, except where inconsistent with 21 CFR 606.121(e)(1)(ii).

Until the current inconsistency between 21 CFR 606.121(e)(1)(ii) and the Version 2.0.0 standard is corrected, a manufacturer that intends to follow the Version 2.0.0 standard instead of 21 CFR 606.121(e)(1)(ii) must seek approval for an exception or alternative for a container label under 21 CFR 640.120. If the alternative is approved, a manufacturer may use the Version 2.0.0 standard to produce labels. Manufacturers that have previously received approval for an exception to or an alternative for a container label for the Version 1.2.0 standard would not need to reapply to use the Version 2.0.0 standard.

To view the guidance document, visit http://www.fda.gov/cber/gdlns/unilabbld.pdf.