The Food and Drug Administration (FDA) issued the final guidance titled “Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products” in effort to reduce the risk of HIV transmission by blood and blood products.

Since the FDA’s recommendation in December 2014, the major change in effect is that men who have sex with men (MSM) will be deferred from donating blood for 12 months since last sexual contact with another man instead of being indefinitely deferred, a policy that was in place for about 30 years.

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The FDA’s initial proposal in December 2014 was in line with the HHS Advisory Committee on Blood and Tissue Safety and Availability’s recommendation to make the deferral period consistent with that of other men and women at increased risk of HIV infection. The final recommendation is based on the examination of a variety of recent studies, epidemiologic data, and shared experiences from other countries that have made recent MSM deferral policy changes.

The guidance also recommends that blood establishments make the appropriate revisions to donor educational materials, donor history questionnaires and accompanying materials, as well as donor requalification and product management procedures. In addition, the guidance states that potential donors with hemophilia or clotting disorders who have received clotting factor concentrates are still deferred but not due to the risk of HIV transmission as originally reflected. Rather, these donors are deferred for their own protection due to potential danger with using large needles during the donation process.

The FDA will continue to review blood donor deferral policies based as clinical data become available, including investigation of shorter deferral interval and individual risk assessment.

“In reviewing our policies to help reduce the risk of HIV transmission through blood products, we rigorously examined several alternative options, including individual risk assessment,” said Peter Marks, M.D., Ph.D., deputy director of the FDA’s Center for Biologics Evaluation and Research. “Ultimately, the 12-month deferral window is supported by the best available scientific evidence, at this point in time, relevant to the U.S. population. We will continue to actively conduct research in this area and further revise our policies as new data emerge.” 

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