FDA Webview
X

Free FDA Notices

FDA Withdraws Guide on Frozen Plasma

07/22/2013

Federal Register Notice: FDA is withdrawing a compliance policy guide entitled “Sec. 253.100 — Use of Units of Plasma and Fresh Frozen Plasma Which Have Been Thawed,” issued 10/1/80, and revised in 3/1995. In a final rule published in the 1/3/12 Federal Register, FDA modified the time limits contained in the instruction circular for when administration of thawed frozen plasma products begins, as required by 21 CFR 606.122(m)(3), to “within a specified time after thawing.” To view this notice, click here.

LATEST NEWS