A transfusion medicine physician in Ohio wonders if institutions are using specific, standardized labels for hematopoietic progenitor cells. She has been unable to find details in any FDA regulation regarding this kind of labeling. She laments that the only mention of standardized labeling she can find is in the Circular of Information for Hematopoietic Progenitor Cells, but she does not know the 'status' of this document, and if it is 'binding' and defines compliant practice. She asks what are others doing in regards to labeling their hematopoietic progenitor stem cells.

The following responses have been received.

1. A Lab Director of a Stem Cells & Immunotherapies Dept., at the Leeds Blood Centre of the NBS in West Yorkshire UK reports that very detailed and explicit labeling guidelines for Stem Cells and related therapeutic cellular products are laid down in the Accreditation Guidelines for JACIE (Joint Accreditation Committee ISCT EBMT). According to his reading of the JACIE Standards, sections D8.200 ("Product Identification") and D8.300 ("Label Content") - together with the list of "proper names of product" in Standard A3.00 - these would apply to the Ohio physician's question.

ADDENDA Sept. 15, 2005

2. A colleague who is very familiar with the workings of the FDA reports that the agency has not yet developed labeling requirements for hematopoietic stem cells because the FDA has NOT yet licensed any. The FDA was asked to comment on AABB's "Circular of Information for Hematopoietic Progenitor Cells", but has not blessed it the way the Office of Biologics Research and Review (OBRR) has blessed the "Circular of Information for the Use of Human Blood and Blood
Components". He concludes saying that the inquiring physician from Ohio should "stay tuned", but the FDA has no requirements at the present time.

ADDENDA Sept. 22, 2005

3. A Customer Regulatory Support Specialist for Gambro BCT reports that ICCBBA has ISBT code 128 standard HPC product codes on their list of ISBT product codes, that there is a section for blood (preceding letter in the code is "E"), a section for HPC & marrow (preceding letter in the code is "S") , and a section for tissues (preceding letter in the code is "T". It is recommended to contact pat.distler@iccbba.com for more information.

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Ira A. Shulman, MD
CBBS e-Network Forum Editor & Moderator