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December 2023 Update: New FDA Guidance for Long-standing Deferral; HIV Changes

Image of December 2023 Update: New FDA Guidance for Long-standing Deferral; HIV Changes. Effective December 2023, the Armed Services Blood Program has incorporated all FDA-recommended revisions to the individualized donor assessment and new screening procedures. All donors, regardless of sexual orientation, will be asked the same screening questions. (Photo: Jonathan Davis)
(Editor’s note: The following article is an updated version of an article released earlier this year in June. This article reflects further relevant changes effective December 2, 2023. The original article, titled “New FDA Guidance for Long-standing Deferral; HIV Changes,” is available at https://health.mil/News/Dvids-Articles/2023/06/02/news446057)

The Food and Drug Administration issued guidance in May of 2023 for blood donors, removing and adjusting some long-standing deferrals. In addition, the FDA is now recommending moving towards an individualized risk-based approach when determining donor eligibility.

Effective December 2, 2023, the Armed Services Blood Program has incorporated all FDA-recommended revisions to the individualized donor assessment and new screening procedures. All donors, regardless of sexual orientation, will be asked the same screening questions.

One of the most significant changes is the FDA guidance document “Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products,” released in May 2023, recommends “eliminating the screening questions specific to men who have sex with men (MSM) and women who have sex with MSM.” Instead, they are now recommending assessing donor eligibility using the same individual risk-based questions relevant to HIV risk for every donor regardless of sex or gender. Donors previously deferred for positive responses to screening questions specific to MSM activity may be re-assessed for blood donation eligibility.

“The Armed Services Blood Program, as well as all civilian blood collection programs, are closely regulated by the FDA. We closely review, and safely implement each guidance issued by the FDA,” explained ASBP Division Chief U.S. Navy Capt. Leslie Riggs. “This one is no different. We welcome the thoroughly researched and safe changes the FDA has provided which has the possibility to increase the donor pool. This change will provide more people with the opportunity to donate blood, and ultimately, when you donate, you can help save a life.”

Now, the temporary deferral will be assessed based on sexual contact and high-risk sexual activity with new partners within the three months prior to the assessment. As this donor assessment language shifts, deferrals are being updated out of an abundance of caution. These deferrals affect those who have taken or are taking any medication to prevent or treat an HIV infection.

The updated deferrals recommended by the FDA, effective December 2, 2023, include a three-month deferral from the most recent dose of certain oral medications, such as short-acting antiviral HIV pre-exposure prophylaxis drugs, otherwise known as PrEP. In addition, there is now a two-year deferral being recommended from the most recent injected version of the medication—the long-acting antiviral PrEP. A permanent deferral is in place for any individual who has ever taken any medication to treat an HIV infection.

The FDA ensured that safety will not be compromised, stating in the May 2023 guidance document that “In considering the available data, we believe implementation of the individual risk-based approach recommended in this guidance will maintain the current high level of safety of blood and blood components.”

“Blood product safety will always be our number one priority,” said Tamara Clayton, quality assurance specialist with ASBP. “This updated guidance better reflects the current donor landscape, but more importantly, these recommendations are backed by sound research that has been conducted worldwide.”

Please contact your local ASBP blood donor center if you have specific questions or concerns about your eligibility to donate.  

About the Armed Services Blood Program

Since 1962, the Armed Services Blood Program is the official blood program of the United States military. Our mission is to provide quality blood products and support to military operations worldwide; from the battlefield to the local hospital, whenever and wherever needed. The ASBP collects, processes, stores, transports, and distributes blood products to service members, their families, retirees and veterans in peace and war. In an ASBP Enterprise view—Military Health Affairs, Defense Health Agency, Service Blood Programs and Combatant Commands—we operate under common goals, metrics, procedures, and work together to shape the future.

The ASBP is one of four organizations tasked with providing a safe blood supply to the Nation. Our program also works closely with our civilian counterparts in times of need to maximize the availability of this national treasure.

To find out more about the ASBP or schedule an appointment to donate, please visit www.health.mil/militaryblood. To interact directly with ASBP staff members or get the latest news, follow us @militaryblood on Facebook and Twitter, and @usmilitaryblood on Instagram.

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Last Updated: April 09, 2024
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