A blood bank technologist reports that the transfusion service where she used to work in the Western United States had been registered with the FDA to perform blood product irradiation. However, recently that transfusion service discontinued blood product irradiation and dropped their FDA registration. When they were registered, they reported all Biological Product Deviations (BPDs), as required by 21 CFR 600.14 and 21 CFR 606.171. However, now that they are no longer registered (or licensed) with FDA, she wonders if BPDs still need to be reported. Thus, she is asking if other unlicensed, unregistered transfusion services are reporting BPDs to the FDA?

The following comments have been received.

ADDENDA May 18, 2005

1. According to Sharon O'Callaghan, Program Surveillance Branch, DIS/OCBQ/CBER/FDA (attribution used with permission), in accordance with 21 CFR 606.171, transfusion facilities that are not licensed or registered with FDA are required to report to FDA any deviations or unexpected events associated with manufacturing that may affect the safety, purity or potency of a distributed product. Manufacturing in a transfusion service may include, but not limited to, compatibility testing, component preparation (e.g., pooling, thawing), labeling, storage, and distribution of units for transfusion. Additional information on BPD reporting may be found at www.fda.gov/cber/biodev/biodev.htm.

2. A Laboratory Coordinator of a hospital transfusion service in New Jersey reports that according to an article by Katharine A. Downes, MD of the University Hospitals of Cleveland (Case Western; attribution used with permission) a BPD is reportable (whether or not a transfusion service is FDA registered, FDA licensed, or neither) if the transfusion service releases a blood product from its control and the error has the potential to effect the safety, potency or purity of the product, even if it is not administered to a patient.

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