Recommendations for Reducing the Risk of Transfusion-Transmitted Hepatitis B Virus; Guidance for Industry; Availability

Summary

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance titled "Recommendations for Reducing the Risk of Transfusion-Transmitted Hepatitis B Virus." The guidance document provides blood establishments that collect blood and blood components, including Source Plasma, with FDA's recommendations for testing blood and blood components for hepatitis B virus (HBV) to reduce the risk of transfusion-transmitted HBV. The recommendations contained in the guidance apply to the collection of Whole Blood and blood components, including Source Plasma. The guidance announced in this notice finalizes the draft guidance titled "Recommendations for Testing Blood Donations for Hepatitis B Surface Antigen" (July 2025 Draft Guidance). The guidance also supersedes the documents titled "Recommendations for the Management of Donors and Units that are Initially Reactive for Hepatitis B Surface Antigen (HBsAg)" (December 1987 Memorandum), "FDA Recommendations Concerning Testing for Antibody to Hepatitis B Core Antigen (Anti-HBc)" (September 1991 Memorandum), "Adequate and Appropriate Donor Screening Tests for Hepatitis B; Hepatitis B Surface Antigen (HBsAg) Assays Used to Test Donors of Whole Blood and Blood Components, Including Source Plasma and Source Leukocytes" (November 2007 Final Guidance), "Requalification Method for Reentry of Blood Donors Deferred Because of Reactive Test Results for Antibody to Hepatitis B Core Antigen (Anti-HBc)" (May 2010 Final Guidance), "Requalification Method for Reentry of Donors Who Test Hepatitis B Surface Antigen (HBsAg) Positive Following a Recent Vaccination against Hepatitis B Virus Infection" (November 2011 Final Guidance), and "Use of Nucleic Acid Tests on Pooled and Individual Samples from Donors of Whole Blood and Blood Components, Including Source Plasma, to Reduce the Risk of Transmission of Hepatitis B Virus" (October 2012 Final Guidance). The guidance supersedes the recommendations specific to HBV in "Recommendations for the Quarantine and Disposition of Units from Prior Collections from Donors with Repeatedly Reactive Screening Tests for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) and Human T- Lymphotropic Virus Type I (HTLV- I)" (July 1996 Memorandum).