Variance for the storage of FFP for 24 hrs post thaw

[Eagle Eye]

FDA Liasion meeting on 4/11/07---FDA revise the regulation for the expiration time for FFP after thawing-------

"The current expiration time of FFP is six hours post thaw if maintained at a temperature of 1-6° C, whereas in the revised regulation, the expiration time will be 24 hours post thaw if maintained at a temperature of 1-6° C. This marks a significant change that will eliminate the requirement for facilities to request a variance under 21 CFR 640.120 for the storage of FFP for 24 hours post thaw."

.....we do not need variance... :) :)

[rcurrie]

It's not a done deal yet, but it is coming. It must be published in the Federal Register before it becomes law. Until then, everyone who is operating without a variance is in technical violation of cGMP regulations. I really took the FDA to task for approving the Circular of Information, with its conflicting message that FFP is good for 24 hours. I talked to people all the way to the top on this, pointing out their inconsistency. I don't know if my conversations had anything to do with their change of heart, but I like to think it did, because I really let them have it.

BC

[Mary]

Good for you. Thanks.

[hmust1]

I used Bob's sample variance letter and applied for a variance to convert to ISBT labeling (last July) and never heard anything back from the FDA. I contacted them recently as we're getting ready to implement ISBT and they, of course, don't have any record of my request.

In the meantime I also learned of the necessary variance to store thawed FFP for 24 hours (that our facility has also never applied for). We never get inspected by either the FDA or AABB, so I admit, it's hard to stay up on this stuff. I have a hard time reading ANYTHING written by the FDA, let alone trying to ask them for something!

With both of these regulations about to be "overturned" is it even worth my while? Of course I want to do the right thing...but I don't want to have to do it multiple times, to no avail, only to not have to do it in the end anyway.

What do you suggest?? Does anyone have a sample variance request for both of these situations...in English?

Thanks,

Heather

[Mary]

Send me your email and I willl send you the info.

[acarrgreer]

I am writing regarding the entry - titled Variance for the storage of FFP for 24 hrs post thaw - that I have reprinted below. This entry references information that was on the AABB web site on 4/16/07. The information on the AABB web site was revised - see below titled 24-hour expiration time for FFP held at 1-6C - to clarify that the final rule that would change this regulation has not yet been issued. The revision was more clear that when the final rule is issued - if there are no changes from the proposed language - then the need for variances will be eliminated.

The variance is still required. AABB has posted a variance template that can be utilized by a facility that needs to obtain the variance.
The template can be found at http://www.aabb.org/Content/Programs_and_Services/Government_Regulatory_Issues/bloodcomponentsresources.htm. Click on Resources.

Sincerely,

M. Allene Carr-Greer, MT(ASCP)SBB
Director, Regulatory Affairs
AABB
voice: 919-658-1689
fax: 919-658-1692
email: acarrgreer@aabb.org
-----------------------------------
Variance for the storage of FFP for 24 hrs post thaw - 04-16-2007, 08:42 AM

FDA Liasion meeting on 4/11/07---FDA revise the regulation for the expiration time for FFP after thawing-------
"The current expiration time of FFP is six hours post thaw if maintained at a temperature of 1-6° C, whereas in the revised regulation, the expiration time will be 24 hours post thaw if maintained at a temperature of 1-6° C. This marks a significant change that will eliminate the requirement for facilities to request a variance under 21 CFR 640.120 for the storage of FFP for 24 hours post thaw."

.....we do not need variance..

-------------

FDA Clarifies Content Addressed at Liaison Meeting (Weekly Report 4/20/07)

The FDA has provided further clarification on two issues — use of a 24-hour period instead of calendar day to define “day of collection†for determining donor suitability and 24-hour expiration time for fresh frozen plasma held at 1-6 C — discussed at last week’s FDA Liaison Meeting. A revised summary of the meeting is available on the AABB Web site.

24-hour expiration time for FFP held at 1-6oC

http://www.aabb.org/Content/Meetings_and_Events/Government_Advisory_Meetings/FDA_Liaison_Meetings/flm041107.htm - FDA Liaison Meeting – 4/11/07 (Revised 4/27)
FDA is currently reviewing comments to the proposed rule entitled “Revisions to Labeling and Storage Requirements for Blood and Blood Components, Including Source Plasma.†If there is no need to change the requirements as proposed, the final rule would eliminate the need for blood establishments to request variances in accordance with 21 CFR 640.120 in order to hold FFP for 24 hours at 1-6oC after thawing or to use ISBT 128 labeling codes.