HCV lookback proposed rule
This article was originally published in The Gray Sheet
Executive Summary
FDA's Center for Biologics Evaluation & Research intends to issue a proposed rule making the hepatitis C virus lookback program a requirement for blood establishments and health care providers, instead of relying on voluntary compliance with a Sept. 23 revised guidance ("The Gray Sheet, Sept. 28, p. 13). The lookback covers patients who may have received HCV-contaminated blood or blood products between 1988 and 1992. The rule is not anticipated to differ substantively from the guidance, which says blood establishments must begin to notify blood "consignees" (hospitals, transfusion services, physicians, etc.) about contaminated blood or blood products by March 23, 1999, and finish by March 23, 2000. Transfusion services must then notify recipients by March 23, 2001