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ISBT Code 128 for HPC Products


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Are there any exceptions for the FDA ruling regarding the implementation of ISBT Code 128 for all blood products within the next couple of years?

I am the Director of a low-volume progenitor cell processing facility. We support only one program and process HPCs for approximately 30 patients annually. Our facility does not provide/process any other blood products.

Is there a source where I can find more detailed information regarding the FDA ruling?

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  • 1 year later...

AABB has on its web site Publication #06-03 that refers to the ISBT 128 requirements. I have verified with the Regulatory Affairs department that the last bullet point of this memo is correct.

If you are working only with HCT/Ps that are either autologous or related allogeneic (classified as 261 products) you are NOT required to implement the ISBT 128 labeling. If however you start using 251 products (e.g. unrelated allos) you will be subject to compliance with ISBT 128 within 60 days of implementing the new treatment.

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