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GUIDANCE DOCUMENT

Requalification Method for Reentry of Donors Who Test Hepatitis B Surface Antigen (HBsAg) Positive Following a Recent Vaccination against Hepatitis B Virus Infection Guidance for Industry November 2011

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2008-D-0263
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research

This guidance document is intended for blood establishments that manufacture Whole Blood and blood components for transfusion or for further manufacture, including Source Plasma and Source Leucocytes. This guidance provides recommendations for a requalification method or process for the reentry of deferred donors who test repeatedly reactive for hepatitis B surface antigen (HBsAg), confirmed positive by neutralization, following a recent vaccination against hepatitis B virus (HBV) infection, and who are not infected by HBV.

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5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2008-D-0263.

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