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Product safetyFDAUnited StatesImports

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

3 November 2026

In plain English

FDA announced final guidance for industry, "Recommendations for Reducing the Risk of Transfusion-Transmitted Hepatitis B Virus," advising blood establishments on HBV testing of blood and blood components, including Source Plasma.

Read the official notice
Topic
Product safety
Regulator
FDA
Published
3 November 2026
For
Imports
Where it applies
United States
Source
FDA (Food and Drug Administration)

From the notice

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 guid
The full text is at the source

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