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.