Thawed Plasma and FDA Requirements

[SBriggs]

I know there are some conversations about this topic already out there, but I haven't been able to find the answer to my questions.

 

My facility would like to being using Thawed plasma with the 5 day outdate.  I am currently not registered by the FDA and need to know if this would require me to register?

Any advice is greatly appreciated.

[David Saikin]

I believe you would need to register as you need to relabel the product, hence you are a manufacturer.

[tbostock]

Hmmm...not sure about this one.  We relabel the product when we thaw it or when we aliquot, and registration is not necessary.  I thought you only had to register if you are actually doing something to modify the product.

[Eagle Eye]

NO. You do not need to register if you are modifying to thaw, prepare aliquot and if you pool cryo you do not need to register with FDA. 

 

On the other hand combining RBC and plasma for neonatal exchange transfusion, washing the RBC, volume reduction of platelet requires FDA registration. 

[bmarotto]

I think that is one of the gray areas.  To thaw plasma and use the FDA recognized post thaw dating you do not have to register.  Changing to "Thawed Plasma" is relabeling as a different product....but one that I do not believe is FDA licensed so you have to make sure the FDA license # is crossed off.  I would tend to agree with Eagle Eye and say you do not have to register.  We do use "Thawed Plasma" and are FDA registered.  We were visited by the FDA a few weeks ago and when she heard we were discontinuing our Autologous Donor program due to low volume, she said we could discontinue our registration if it wasn't that we irradiated blood.  She knew we use Thawed Plasma and did not mention that would require that we remain registered.    

[SMW]

You do not need to register with the FDA to convert FFP/FP24 to the 5day Thawed Plasma product.  You are not "manufacturing" a new product, rather just applying a new product code and expiration date.  However, since you need to apply a new ISBT128 product code label, it may change your registration requirements with ICCBBA.