Does the FDA still require a variance to modify thawed ffp to 5 day thawed plasma?

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.

I didn't think you needed a variance, it's an unlicensed product. I'll have to research/think.

Heard from the FDA.  Variance is no longer required.  This is an unlicensed product and may not be shipped across state lines.

 

Thanks for posting David.

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.

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?