"Guidance for industry: current good manufacturing practice for blood and blood components: (1). Quarantine and disposition of units from prior collections from donors with repeatedly reactive screening test for antibody to hepatitis C virus (anti-HCV); (2). Supplemental testing, and the notification of consignees and blood recipients of donor test results for anti-HCV;" availability--FDA. Notice.
The Food and Drug Administration (FDA) is announcing the availability of a guidance document (dated September 1998) entitled "Guidance for Industry: Current Good Manufacturing Practice for Blood and Blood Components: (1) Quarantine and Disposition of Units From Prior Collections From Donors With Repeatedly Reactive Screening Test for Antibody to Hepatitis C Virus (Anti-HCV); (2) Supplemental Testing, and the Notification of Consignees and Blood Recipients of Donor Test Results for Anti-HCV." The guidance document provides recommendations for donor screening and supplemental testing for antibody to hepatitis C virus (HCV), notification of consignees and quarantine of prior collections from a donor who later tests repeatedly reactive for antibody to HCV, notification of recipients of blood and blood components at increased risk for transmitting HCV.
D001771:Blood Banks / Q000592:standards*; D001782:Blood Donors; D017408:Guidelines as Topic; D006526:Hepatitis C / Q000517:prevention & control*; D006801:Humans; D018580:Mandatory Testing / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration