Regulatory Focus™ > News Articles > FDA: Blood Products Policy Guide 'Obsolete'

FDA: Blood Products Policy Guide 'Obsolete'

Posted 27 June 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) has withdrawn its compliance policy guide (CPG) governing the registration of blood banks and other companies  that prepare human blood and blood products-the third such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.


Read more:

FDA - Compliance Policy Guide Sec. 230.110--Registration of Blood Banks, Other Firms Collecting, Manufacturing, Preparing, or Processing Human Blood or Blood Products; Withdrawal


Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe