Patients with hereditary hemochromatosis undergo regular therapeutic phlebotomy in order to induce iron deficiency. The Food and Drug Administration allows this blood to be transfused provided it meets certain requirements.


Blood from a patient with hereditary hemochromatosis can be transfused if:

(1) the patient meets all donor criteria to exclude hazardous conditions

(2) one of the following:

(2a) the blood is prominently labeled with the patient's diagnosis AND the interval between blood donations is at least 8 weeks

(2b) the blood center obtains a variance (no label required AND the interval between donations can be less than 8 weeks)


To obtain the variance the blood center must provide free phlebotomy to all patients with hemochromatosis even if the blood is not used for transfusion. This seemingly bizarre requirement stems from the FDA's belief that a patient would deny hazardous exposures so that s/he could donate for free versus pay for a therapeutic phlebotomy procedure.


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