A colleague in Massachusetts wonders about current FDA regulations regarding donor eligibility for patients who have been diagnosed with systemic lupus erythematosus ('lupus'). She is asking this question because a prospective blood donor recently claimed that a new 'ruling' has been handed down from the FDA saying that individuals with lupus can be acceptable blood donors, if symptom-free. She wants to know what the policy and practice is at other centers.

The following responses have been received.

1. A colleague on the East coast who is familiar with current federal rules and regulations for donor eligibility reports that he is unaware of any new 'rulings' specifically addressing lupus or any of the other autoimmune diseases in blood donors. However, he points out that a 'Draft Guidance for Industry', entitled "Acceptable Full-length Donor History Questionnaire and Accompanying Materials for Use in screening Human Donors of Blood and Blood Components" was issued by the FDA in April 2004, and might account for why the individual with lupus believes they may be an acceptable blood donor. The draft guidance states 'a donor's eligibility to donate blood and blood components is determined in part by a physical assessment and medical history interview to determine whether the donor is free of any disease transmissible by blood transfusion (CFR 640.3 and 640.63)'. Apparently a blood bank director could interpret the language in this draft guidance to mean an otherwise qualified blood donor with inactive lupus (which is not proven to be transmissible by transfusion) could potentially be eligible as a blood donor. Although this document is issued in draft and is presently gathering public comments, he understands that some organizations are apparently incorporating it into their SOP.

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