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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

Download the Final Memorandum
Final
Docket Number:
FDA-2022-D-0497
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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5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2022-D-0497.

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(800) 835-4709
(240) 402-8010
 
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