FDA has always allowed individuals diagnosed with hemochromatosis to donate blood. However, FDA is now allowing variances to the requirements that blood establishments 1) label such blood with the donor's disorder, and 2) have a physician examine the donor at the time of donation if less than eight weeks has passed since the previous donation. These variances are specific for individuals with hereditary hemochromatosis. The existing regulations require that blood establishments using blood collected during therapeutic bleedings label these units with the disease that necessitated the therapeutic bleeding (21 CFR Part 640.3 (d)) and limit the frequency of whole blood collections (21 CFR Part 640.3 (f)). The CFR sections are availble at: http://www.access.gpo.gov/nara/cfr/waisidx_05/21cfr640_05.html. FDA has the authority to permit exemptions to the blood regulations under the provisions of 21 CFR 640.120, Alternative Procedures. In August 2001, FDA issued Guidance for Industry: Variances for Blood Collection from Individuals with Hereditary Hemochromatosis providing recommendations to blood establishments that wish to apply for these variances. Refer to the guidance document for the conditions blood establishments must meet in order for us to approve the variance requests. Not all blood establishments have applied for these variances. Ultimately, it is the decision of each blood establishment to apply for any variance. A list of the facilities that have been granted the hemochromatosis-related variances is available at http://www.fda.gov/cber/blood/hemochromvar.htm. In summary, when a blood establishment desires to use blood from a therapeutic hemochromatosis bleeding for transfusion purposes, the blood establishment must either 1) label the collected blood with the donor's disorder and have a physician examine the donor on the day of donation if less than eight weeks has passed since the previous donation, or 2) apply for the variances. | 
