FDA: Blood Products Policy Guide 'Obsolete'
Posted 27 June 2012 | By
The US Food and Drug Administration (FDA) has withdrawn its compliance policy guide (CPG) governing the registration of blood banks and other companies that prepare human blood and blood products-the third such withdrawal made this week.
In a Federal Register notice posted late on 26 June, FDA said it believes its 1974 CPG, Registration of Blood Banks, Other Firms Collecting, Manufacturing, Preparing or Processing Human Blood or Blood Products (CPG 7134.01), is "obsolete" as the result of other advances at the agency.
FDA explained since the CPG's last update in 2000, "the regulations for blood establishment registration under part 607 have been amended several times."
FDA's latest blood product guidance may be found on its website.
FDA - Compliance Policy Guide Sec. 230.110--Registration of Blood Banks, Other Firms Collecting, Manufacturing, Preparing, or Processing Human Blood or Blood Products; Withdrawal