Final guidance, “Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products.”

FDA is announcing the availability of the final guidance, “Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products.”  The final guidance may be found on FDA’s website at http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/UCM446580.pdf.

The major change being effected is that men who have sex with men will be deferred from donating blood for twelve months since last sexual contact with another man, instead of being indefinitely deferred.

As we make this change, we affirm our commitment to further progressing blood donor deferral policies as supported by scientific evidence that is developed, including investigation of shorter deferral interval and individual risk assessment.

If you have any questions, please contact FDA’s Center for Biologics Evaluation and Research atocod@fda.hhs.gov.

Richard Klein
Office of Health and Constituent Affairs
Food and Drug Administration

Kimberly Struble
Division of Antiviral Products
Food and Drug Administration

Steve Morin
Office of Health and Constituent Affairs
Food and Drug Administration

For more information about the HIV Liaison Program visit the FDA Patient Network