Did you have to advise the FDA when you started extending the expiration date beyond 24 hours?

I do plan on it, but we haven't actually implemented it yet.

Did you have to advise the FDA when you started extending the expiration date beyond 24 hours?

Do you have to notify the FDA if you are going to start extending the expiration date to 5 days?

My impression is that you don't need to (but then we no longer have an active FDA registration, we are just a transfusion service.) Thawed Plasma is not a licensed product, so any license # needs to be crossed off the unit. Product name needs to be changed from FFP (or FP24) to Thawed Plasma. We are not ISBT, yet, but they do have codes for all of these.

Linda Frederick

Thanks.

Someone expressed the opinion to me that plasma frozen within 24 hours (FP24) had the same levels of factors as 5 day plasma. Has anyone else heard this? I had been under the impression that FP24 had almost the same level of factors as FFP.

My understanding is that 24 hour plasma and 5 day plasma are essentialy equal in factors but have reduced labile factors when compared with FFP. (How much reduced varies with the studies you read but not by much.) Our clinical pathology group has decided that the difference is not enough to worry about so we use them interchangably.