Docket Number:
FDA-2012-D-0307
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research

We, FDA, are issuing this guidance document to provide you, blood establishments that collect blood and blood components, with revised recommendations intended to reduce the possible risk of transmission of Creutzfeldt-Jakob disease (CJD) and variant Creutzfeldt-Jakob disease (vCJD) by blood and blood components.  The recommendations in this guidance apply to the collection of Whole Blood and blood components intended for transfusion or for use in further manufacturing, including Source Plasma.  We are revising or removing our prior recommendations to screen blood donors for:  1) geographic risk of possible exposure to bovine spongiform encephalopathy, including time spent on United States (U.S.) military bases in Europe; 2) receipt of a blood transfusion in certain vCJD risk countries; 3) risk factors for iatrogenic CJD (i.e., a history of taking  cadaveric pituitary human  growth hormone (hGH)); 4) having blood relatives with CJD; and 5) a history of injecting bovine insulin.  These changes are summarized in the Appendix of this guidance.

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Contact Point
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Food and Drug Administration
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