David Saikin Posted September 22, 2016 Share Posted September 22, 2016 Does the FDA still require a variance to modify thawed ffp to 5 day thawed plasma? Link to comment Share on other sites More sharing options...
Teristella Posted September 22, 2016 Share Posted September 22, 2016 Anecdotal evidence, but at my previous facility we routinely modified everything to 5 day with no variances. On the other hand, the VA lab I'm at now has an FDA license number and is FDA inspected just to thaw products. I'm guessing this was a requirement for some kind of product modification they did in the past and it's just been left alone. David Saikin 1 Link to comment Share on other sites More sharing options...
goodchild Posted September 22, 2016 Share Posted September 22, 2016 I didn't think you needed a variance, it's an unlicensed product. I'll have to research/think. David Saikin 1 Link to comment Share on other sites More sharing options...
David Saikin Posted September 30, 2016 Author Share Posted September 30, 2016 Heard from the FDA. Variance is no longer required. This is an unlicensed product and may not be shipped across state lines. goodchild, tcoyle, Maureen and 2 others 5 Link to comment Share on other sites More sharing options...
AMcCord Posted October 1, 2016 Share Posted October 1, 2016 Thanks for posting David. Link to comment Share on other sites More sharing options...
profbaud Posted September 18, 2017 Share Posted September 18, 2017 Not for 5 day plasma but they used to require it if you extended the expiration date of thawed FFP from 6 hrs to 24 hrs. Link to comment Share on other sites More sharing options...
Laurie Underwood Posted September 19, 2017 Share Posted September 19, 2017 We received a variance in 2011 to extend the expiration date of thawed FFP from 6 hours to 24 hours. Is this still required or has this been stopped? Link to comment Share on other sites More sharing options...
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