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Donor Eligibility Criteria

Blood providers are often asked about the donor eligibility criteria for men who have had sexual contact with other men. While all donor eligibility criteria are set by the U.S. Food and Drug Administration (FDA), blood centers have opportunity to provide input that may help shape future changes to U.S. FDA policy. We have joined other blood centers across the country to actively work with U.S. FDA to update the existing deferral for men who have had sexual contact with other men during the 90 days prior to their desired date of donation. For a comprehensive overview, see ImpactLife Responds to Calls for Change to Donor Eligibility Criteria. To review frequently asked eligibility questions, click here

Latest Developments

January 27, 2023: The Food and Drug Administration is expected to release draft guidance to change the blood donation deferral of males who have sex with another male. ImpactLife, along with America’s Blood Centers, the Association for the Advancement of Blood and Biotherapies, and blood centers across the country are united in support of evidence-based change to an individual sexual-behavior-based screening process for all donors intended to expand blood availability while maintaining blood safety.

Once blood centers have been issued the FDA draft guidance, a finalized version will be available after a period of review. At that time, blood centers will have 6–12 months to implement the changes involving modification to donor management software, donor screening and questionnaire protocols that will allow for new donor eligibility. ImpactLife will update communications as information becomes available. 

FDA News Release on New Draft Guidance (Jan. 27, 2023)

America's Blood Centers news release (Jan. 27, 2023)

Additional Resources

Government of Canada  United Kingdom Department of Health and Social Care  Examining FDA’s policies on blood donations from gay and bisexual men

See ImpactLife Diversity, Equity, Inclusion Initiative

frequently asked eligibility questions

Scroll down to review frequently asked eligibility questions from the LGBQTIA+ community. See additional donor criteria here.

FAQs

  • What is the MSM Deferral, and why does ImpactLife enforce this guideline?

    ImpactLife is regulated and audited by numerous organizations and governing bodies to ensure the safety of the blood and blood products we provide. One of those organizations is the U.S. Food and Drug Administration (FDA) which regulates all blood centers in the United States.

    The FDA guidance “Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products” released in April 2020 states that men who had sex with men (MSM) will be deferred for three (3) months from the date of last sexual encounter.

    As with all U.S. blood providers, ImpactLife is required to follow donor eligibility criteria that are set by the FDA. At the height of the HIV/AIDS crisis in the 1980s, the FDA enacted a lifetime deferral on MSM, which remained in place until 2015, when the deferral period was changed to one year.

    On January 27, 2023, FDA released draft guidance to change the blood donation deferral of males who have sex with another male. The draft guidance is now open for a 60-day period of comment and review. Once final guidance is issued, blood centers will have 6 - 12 months to implement the changes involving modification to donor management software, donor screening and questionnaire protocols that will allow for new donor eligibility. (See the FDA news release on the draft guidance and other updates here: www.bloodcenter.org/update.) 

  • Does ImpactLife support the FDA’s policy change regarding men who have sex with men?

    Yes, ImpactLife supports the change and has implemented the most recent FDA guidance concerning MSM. The changes are based on data from new studies showing the change can safely expand the nation’s blood supply. ImpactLife remains committed to additional research studies that can help guide future donor eligibility policies that are based on individual risk assessment.

    Three of the nation’s largest blood centers – Vitalant, OneBlood, and the American Red Cross – are conducting a pilot study funded by FDA that could lead to a significant change to blood donor eligibility for MSM.

    The research is called the ADVANCE Study: Assessing Donor Variability And New Concepts in Donor Eligibility. For information and updates, see www.advancestudy.org.

    On January 27, 2023, FDA released draft guidance to change the blood donation deferral of males who have sex with another male. The draft guidance is now open for a 60-day period of comment and review. Once final guidance is issued, blood centers will have 6 - 12 months to implement the changes involving modification to donor management software, donor screening and questionnaire protocols that will allow for new donor eligibility. (See the FDA news release on the draft guidance and other updates here: www.bloodcenter.org/update.) 

  • Did the FDA recently change its policy regarding men who have sex with men (MSM)?

    Yes. On April 2, 2020 the FDA announced changes to its donor eligibility policy titled: “Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products.” The policy change shortens the deferral criteria for MSM from 12 months to three months. ImpactLife has implemented this change.

    On January 27, 2023, FDA released draft guidance to change the blood donation deferral of males who have sex with another male. The draft guidance is now open for a 60-day period of comment and review. Once final guidance is issued, blood centers will have 6 -12 months to implement the changes involving modification to donor management software, donor screening and questionnaire protocols that will allow for new donor eligibility. (See the FDA news release on the draft guidance and other updates here: www.bloodcenter.org/update.) 

  • Can I donate if I was deferred under the previous 12-month deferral policy for MSM?

    People who were deferred under the previous 12-month deferral policy for MSM and who may now meet the new 3- month MSM deferral policy, must contact ImpactLife to have their donor profile updated in our computer system. If the person’s donor profile is not updated accordingly, the person will remain deferred. First time donors do not have to reach out. Please note, all donors are required to answer a series of questions on the FDA’s Donor History Questionnaire (DHQ) before donating.  Depending on the answers, there may be other circumstances that can cause a person to be deferred.

    On January 27, 2023, FDA released draft guidance to change the blood donation deferral of males who have sex with another male. The draft guidance is now open for a 60-day period of comment and review. Once final guidance is issued, blood centers will have 6 -12 months to implement the changes involving modification to donor management software, donor screening and questionnaire protocols that will allow for new donor eligibility. (See the FDA news release on the draft guidance and other updates here: www.bloodcenter.org/update.) 

  • I am a man who has had sex with another man in the past three months. Do I have to abstain from having sex with men for three months before donating blood?

    Yes. The FDA revised guidance states, “Defer for 3 months from the most recent sexual contact, a man who has had sex with another man during the past 3 months." Please note, all donors are required to answer a series of questions on the Donor History Questionnaire (DHQ) before donating. All potential donors must meet all applicable donor criteria in order to give blood.

    On January 27, 2023, FDA released draft guidance to change the blood donation deferral of males who have sex with another male. The draft guidance is now open for a 60-day period of comment and review. Once final guidance is issued, blood centers will have 6 -12 months to implement the changes involving modification to donor management software, donor screening and questionnaire protocols that will allow for new donor eligibility. (See the FDA news release on the draft guidance and other updates here: www.bloodcenter.org/update.) 

  • I am a man who is in a monogamous MSM relationship. Am I allowed to donate if I have had sex with a man in the last three months?

    No. The FDA revised guidance states, “Defer for 3 months from the most recent sexual contact, a man who has had sex with another man during the past 3 months." All U.S. blood collection organizations must follow this federal requirement. Please note, all potential donors must meet all applicable donor criteria in order to give blood.

    On January 27, 2023, FDA released draft guidance to change the blood donation deferral of males who have sex with another male. The draft guidance is now open for a 60-day period of comment and review. Once final guidance is issued, blood centers will have 6 - 12 months to implement the changes involving modification to donor management software, donor screening and questionnaire protocols that will allow for new donor eligibility. (See the FDA news release on the draft guidance and other updates here: www.bloodcenter.org/update.) 

  • I am a transgender individual. Am I allowed to donate?

    There is no deferral associated with being transgender, and your eligibility will be based upon the criteria associated with your self-identified, self-reported gender. The latest FDA revised guidance states, “In the context of the donor history questionnaire, FDA recommends that male or female gender be taken to be self-identified and self-reported.” Although there is no deferral associated with being transgender, you may be deferred for other reasons. For instance, if you identify as male and have had sex with men in the last three months, you will be deferred from donating per the MSM guidelines outlined above and you must meet all other eligibility guidelines to donate blood. Please note, all potential donors must meet all applicable donor criteria in order to give blood.

    On January 27, 2023, FDA released draft guidance to change the blood donation deferral of males who have sex with another male. The draft guidance is now open for a 60-day period of comment and review. Once final guidance is issued, blood centers will have 6 - 12 months to implement the changes involving modification to donor management software, donor screening and questionnaire protocols that will allow for new donor eligibility. (See the FDA news release on the draft guidance and other updates here: www.bloodcenter.org/update.) 

  • I do not identify as male or female. Will this impact my ability to donate?

    While being non-binary is not cause for a deferral, it is important to note that the regulated software we use to maintain our donor records system does not feature a gender non-binary option at this time. ImpactLife continues to work our software provider to update our system so that we can accept non-binary donors.

  • Are there other donor eligibility criteria I will need to meet to donate?

    Yes. To help ensure donor safety and safety of the blood supply, the FDA requires that all potential blood donors answer a series of questions on the Donor History Questionnaire (DHQ) prior to donation. Click here for Information on Donor Eligibility.

    On January 27, 2023, FDA released draft guidance to change the blood donation deferral of males who have sex with another male. The draft guidance is now open for a 60-day period of comment and review. Once final guidance is issued, blood centers will have 6 - 12 months to implement the changes involving modification to donor management software, donor screening and questionnaire protocols that will allow for new donor eligibility. (See the FDA news release on the draft guidance and other updates here: www.bloodcenter.org/update.) 

  • What is the latest on changes to donor eligibility criteria for men who have sexual contact with men?

    On January 27, 2023, FDA released draft guidance to change the blood donation deferral of males who have sex with another male. The draft guidance is now open for a 60-day period of comment and review. Once final guidance is issued, blood centers will have 6 - 12 months to implement the changes involving modification to donor management software, donor screening and questionnaire protocols that will allow for new donor eligibility. (See the FDA news release on the draft guidance and other updates here: www.bloodcenter.org/update.)