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MEMORANDUM

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

Final
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research

The attached recommendations by the Food and Drug Administration (FDA) to blood and plasma establishments concern the quarantine and disposition of prior collections of blood, blood components and Source Plasma from a donor who subsequently tests repeatedly reactive for hepatitis B surface antigen (HBsAg), antibody to hepatitis B core (anti-HBc), antibody to hepatitis C virus (anti-HCV), or antibody to human T-lymphotropic virus, type I (anti-HTLV-I).


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Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

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Food and Drug Administration
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Rockville, MD 20852

All comments should be identified with the title of the guidance.

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