FDA blood product regulations

Executive Summary

Agency is amending regulations to allow alternative methods for licensing, testing, collecting, storing and distributing blood and blood products. Final rule, published in the March 21 Federal Register, also removes the previous requirement that labeling state that a product was nonreactive when tested for hepatitis B surface antigen. The final rule is effective March 21, 1991 and FDA is requesting that manufacturers of products prepared from whole blood submit amended draft labeling before July 19, 1990.