Current good manufacturing practice for blood and blood components; notification of consignees and transfusion recipients receiving blood and blood components at increased risk of transmitting hepatitis C virus infection ("lookback"). Final rule.
The Food and Drug Administration (FDA) is requiring establishments collecting Whole Blood or blood components, including Source Plasma and Source Leukocytes, to establish, maintain, and follow an appropriate system for identifying blood and blood components previously donated by a donor who tests reactive for evidence of hepatitis C virus (HCV) infection on a subsequent donation identified either by current testing or after a review of historical testing records, or when the collecting establishment is made aware of other reliable test results or information indicating evidence of HCV infection. Such collections may be at increased risk of transmitting HCV infection. FDA is requiring collecting establishments to quarantine prior in-date blood and blood components from such a donor, to notify consignees of prior in-date blood and blood components from such a donor for quarantine purposes, and to perform further testing on the donor. FDA is also requiring consignees to notify transfusion recipients of blood and blood components from such a donor, as appropriate. In addition, FDA is revising the human immunodeficiency virus (HIV) "lookback" requirements for greater consistency with the HCV "lookback" requirements, and extending the record retention period to 10 years. FDA is taking this action to help ensure the continued safety of the blood supply and to help ensure that information is provided to recipients of blood and blood components that may have been at increased risk of transmitting HIV or HCV infection. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document entitled "Guidance for Industry: 'Lookback' for Hepatitis C Virus (HCV): Product Quarantine, Consignee Notification, Further Testing, Product Disposition, and Notification of Transfusion Recipients Based on Donor Test Results Indicating Infection with HCV'' (the "lookback" guidance). We are also issuing this final rule in conjunction with a companion interim final rule published by the Centers for Medicare and Medicaid Services (CMS) elsewhere in this issue of the Federal Register.
D001771:Blood Banks / Q000331:legislation & jurisprudence*; D001782:Blood Donors / Q000331:legislation & jurisprudence*; D001803:Blood Transfusion / Q000331:legislation & jurisprudence*; D018563:Disease Notification; D018562:Disease Transmission, Infectious / Q000331:legislation & jurisprudence*; D006526:Hepatitis C / Q000097:blood*; D006801:Humans; D019221:Mandatory Reporting; D014481:United States; D014486:United States Food and Drug Administration