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FDA Changes FAQs

FDA Changes FAQs

Following extensive study, the U.S. Food and Drug Administration has changed its guidelines for blood donor eligibility related to gay and bisexual men. The new guidelines will allow more people to give blood. 

The FDA is basing eligibility to give blood on individual risk factors for HIV instead of sexual orientation. Eligibility will be determined via the pre-donation questionnaire that every donor must complete. 

Details about the changes are on the FDA website. 

The agency studied data from multiple sources: 
  • It looked at information from the United Kingdom and Canada, both of which made similar changes to their guidelines. 
  • It examined information from the Transfusion Transmissible Infections Monitoring System, a federal system that tracks blood donating testing data. 
  • It evaluated the effectiveness of already-mandated testing for HIV. 
  • It funded the Assessing Donor Variability And New Concepts in Eligibility (ADVANCE) study, which examined several HIV risk factors. 
The FDA’s assessment of the data indicated that questions based on behavior rather than sexual orientation would serve to further safeguard the blood supply when used in conjunction with extensive and sensitive testing already in place. Details are included in the FDA’s final guidance for the industry. 

On the pre-donation questionnaire that every donor must complete, all donors will be asked a series of questions regarding their sexual behavior, including whether they’ve had new and/or multiple sexual partners in the past three months.  

Differences in sexual behavior carry different HIV risk-levels. Science-based data supports FDA’s guideline changes.  

Donors taking oral medications to prevent HIV transmission like PrEP will be deferred for three-months. Those taking injectable PrEP will be deferred for two years from the date of the most recent dose. This is due to the effectiveness of these medications in suppressing the presence of HIV in the blood, especially during the “window period” of infection—the time between infection and its ability to be recognized by testing.  

This is just one of the many medications that can result in an individual being unable to donate blood while taking the medication and for some time after. 

Yes, thanks to the extensive research data and studies by the FDA, as well as the highly effective nature of the nucleic acid testing for HIV and the donor questionnaire. 

Deferring donations from gay men – and women who had sex with bisexual men – was the result of the AIDS epidemic of the 1980s and the lack of effective testing at the time. 

The announcement from the FDA about the changes 

FDA outline of guidelines for blood centers 

FDA system for keeping the blood supply safe 

In 2019, the FDA updated its guidance on active-duty and civilian military members and their families who were in Europe. You are now eligible to give blood.

Previously, if you were stationed for more than six months in Germany, Belgium, the Netherlands from 1980-90, or Greece, Turkey, Spain, Portugal or Italy from 1980-96, you could not donate blood. 

If you lived in the United Kingdom, Ireland and France between 1980-2001, you are now eligible to give blood.

If you received a blood transfusion in the United Kingdom, France and Ireland from 1980-present are also eligible to give blood. Learn more.