Revised Checklist Question

Posted September 15, 2009

TRM.43600 (REVISED 09/15/2009)

For each component, does the label specify all of the FDA required information, and are requirements for proper labeling of components defined?

Note: Required information may be offered separately in an approved “circular of information,” provided that the component label refers to the circular. All steps of blood component labeling must be defined in the procedure manual. There are two acceptable labeling systems in the US: the 1985 Uniform Labeling Guideline (FDA), and ISBT 128. The latter is recommended; if the laboratory does not use ISBT 128 routinely, it should have a plan for transitioning to the system. The laboratory must have a validated system to receive and manage all blood components that come into inventory, including those labeled with ISBT 128.

References

1. Food and Drug Administration. Washington, DC: US Government Printing Office, 1999(Apr 1):[21CFR600-21CFR.660]
2. An acceptable Circular of Information for the use of blood and blood components. FDA Guidance, December 2003.
3. Food and Drug Administration: Bar Code Label Requirements for Human Drug Products and Biological Products; Final Rule, Fed. Register (2004;69:9120-9171 4)
4. Recognition and use of a standard for uniform blood and blood component container labels. FDA Guidance, September 2006.