Guidance for Industry. Current Good Manufacturing Practice for Blood and Blood211 Components: (1) Quarantine and Disposition of Units from Prior Collections from 211 Donors with Repeatedly Reactive Screening Tests for Antibody to Hepatitis C Virus 211 (An

摘要

This document contains guidance that supersedes the HCV sections of the Food and211u001eDrug Administration (FDA) memorandum of July 19, 1996, entitled, Recommendations 211u001efor the Quarantine and Disposition of Units from Prior Collections from Donors 211u001ewith Repeatedly Reactive Screening Tests for Hepatitis B Virus (HBV), Hepatitis C 211u001eVirus (HCV), and Human T-Lymphotropic Virus Type I (HTLV-I). Additionally, this 211u001eguidance replaces FDAs guidance issued on March 20, 1998 entitled, Guidance for 211u001eIndustry: Supplemental Testing and the Notification of Consignees of Donor Test 211u001eResults for Antibody to Hepatitis C Virus(Anti-HCV). The FDA recommendation 211u001econtained in this document are provided to enable quarantine and disposition of 211u001eunits from prior collections from donors with repeatedly reactive screening tests 211u001efor HCV.