Is an FDA variance needed to label a product as "Thawed Plasma" with a 5 day expiration? The label does not say "fresh" anywhere on the unit

Thawed Plasma is an unlicensed product and an FDA variance is not needed to use. The FDA has not received data to demonstrate that Thawed Plasma meets prescribed requirements of safety, purity and potency, and therefore is not licensed for distribution in interstate commerce. Even if a variance request is submitted to FDA, the FDA will not provide since they don't recognize the product.

I am resurrecting this post. I am about to discard 2 units of FFP that were thawed yesterday and have reached their 24 hour expiration date. According to the AABB TM (page 204), I can relabel the units as Thawed Plasma and keep the units for 4 more days at 1-6C. According to this thread, I don't need a FDA variance to do this.

How many of you in Transfusion Services relabel FFP as Thawed Plasma after 24 hours? Do you relabel by adding a tag and what other information do you included on that tag. Do you inform the physician that the product is Thawed Plasma and has reduced levels of factor V and VIII?

It seems that if I am going to do this I should write a policy first and get the pathologist's approval.....

Thank you!

After I posted I noticed there were many threads with information on 5 day thawed plasma. I now realize many many transfusion services use 5 day plasma. I also saw Cliff's post about getting labels from Shamrock--that is helpful. So thank you everyone! I am still a BB newbie and appreciate this site! I will obtain the pathologist's approval, the transfusion committee approval, write a policy and order labels....