Recommendations for Reducing the Risk of Transfusion-Transmitted Hepatitis B Virus; Guidance for Industry; Availability
Published . Updated .
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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 The guidance announced in this notice finalizes the draft guidance titled "Recommendations for Testing Blood Donations for Hepatitis B Surface Antigen" (July 2025 Draft Guidance).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).
Directly affected
- No company is named in this report.
Indirectly affected
- XLV Health Care Select Sector SPDR
Health Care Select Sector SPDR: it holds drugmakers and health companies. Linked by “drug” (pharma and health) in this story.
- XBI SPDR S&P Biotech ETF
SPDR S&P Biotech ETF: it holds drugmakers and health companies. Linked by “drug” (pharma and health) in this story.
- LLY Eli Lilly and+19.9% 30d
Eli Lilly and (pharmaceutical preparations): drugmakers move with drug pricing, approvals and health policy. Linked by “drug” (pharma and health) in this story.
- JNJ Johnson & Johnson+1.9% 30d
Johnson & Johnson (pharmaceutical preparations): drugmakers move with drug pricing, approvals and health policy. Linked by “drug” (pharma and health) in this story.
- PFE Pfizer+7.3% 30d
Pfizer (pharmaceutical preparations): drugmakers move with drug pricing, approvals and health policy. Linked by “drug” (pharma and health) in this story.
- MRK Merck+5.9% 19d
Merck (pharmaceutical preparations): drugmakers move with drug pricing, approvals and health policy. Linked by “drug” (pharma and health) in this story.
Price reaction, T-5 to T+3
| Ticker | T-5 | T-3 | T-1 | T0 | T+1 | T+2 | T+3 |
|---|---|---|---|---|---|---|---|
| XLVNo price data for this ticker | — | — | — | — | — | — | — |
| XBINo price data for this ticker | — | — | — | — | — | — | — |
| LLYNo price data for this ticker | — | — | — | — | — | — | — |
| JNJNo price data for this ticker | — | — | — | — | — | — | — |
| PFENo price data for this ticker | — | — | — | — | — | — | — |
| MRKNo price data for this ticker | — | — | — | — | — | — | — |
Closing-price change versus T-1, the last close before the story. T0 to T+3 fill in after each market close. Prices: Alpaca IEX.
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 establish…
Source: Federal Register
Trades by members of Congress and officials in the stocks in this story
- Rep. Rohit Khanna bought Eli Lilly (LLY) (held by a spouse), worth $1,001 - $15,000 on 4 Sep 2026. That is 59 days before publication. Filed 7 Oct 2026. View the filing.
- Rep. Thomas H. Kean Jr sold Johnson & Johnson (JNJ), worth $1,001 - $15,000 on 30 Sep 2026. That is 33 days before publication. Filed 30 Oct 2026. View the filing.
- Rep. Rohit Khanna bought Johnson & Johnson (JNJ) (held by a spouse), worth $1,001 - $15,000 on 25 Sep 2026. That is 38 days before publication. Filed 7 Oct 2026. View the filing.
- Rep. Lloyd Doggett bought Johnson & Johnson (JNJ), worth $1,001 - $15,000 on 8 Sep 2026. That is 55 days before publication. Filed 5 Oct 2026. View the filing.
- Rep. Rohit Khanna sold Pfizer (PFE) (held by a spouse), worth $1,001 - $15,000 on 4 Sep 2026. That is 59 days before publication. Filed 7 Oct 2026. View the filing.
- Donald J Trump, an executive branch official, bought Pfizer (PFE), worth $100,001 - $250,000 on 21 Aug 2026. That is 73 days before publication. Filed 8 Oct 2026. View the filing.
- Rep. Maria Elvira Salazar sold Merck (MRK), worth $1,001 - $15,000 on 24 Sep 2026. That is 39 days before publication. Filed 7 Oct 2026. View the filing.
- Rep. Maria Elvira Salazar bought Merck (MRK), worth $15,001 - $50,000 on 19 Aug 2026. That is 75 days before publication. Filed 9 Sep 2026. View the filing.
Public disclosure filings, not a recommendation. The filing link is the source document. News use of these reports still sits under 5 U.S.C. § 13107(c).
This story
25 out of 100
“Recommendations for Reducing the Risk of Transfusion-Transmitted Hepatitis B Virus; Guidance for Industry; Availability” scores 25 out of 100. The score uses 2 sources.