I would be interested in how many of you are now putting a 6 hour expiration time on thawed FFP.(FDA Reg 21CFR 606 122(m)(3).

We are not yet. I am debating about whether to request the variance. I've never done that before, so I am not sure how the process works. Did FDA recently change this law or did we just miss it all these years?

Our expiration for thawed FFP is 24 hours. I remember expiring it in 6 hours about 10 years ago but I don't remember when we changed it to 24 hours.

We have also used 24 hours for longer than I can remember, without requesting a variance, as this was the AABB standard.

I find it interesting that this regulation applies to what must be written into the Circular of Information. The current FDA approved circular in use (rev 2002) and the one approved by the FDA in 2003, both state that if not used immediately, thawed FFP can be stored for up to 24 hrs.

In the November issue of the AABB Regulatory Newsbriefs, there were further comments that indicate the FDA has asked their inspectors to use "enforcement discretion" in lieu of the current practice of requesting variances.

I am not sure when it happened, but I read about it in the summary of the Ask The Experts questions from the last AABB meeting. I emailed the FDA about it and will give you the info when I get it. The CRF fro a variance is: 21 CFR 640.120.

I am confused. Why would the FDA require anything for outdating FFP in 6 hours instead of 24? I know there is a move to go to 5 days. Are we maybe not all talking about the same thing here?

I was probably one of those that asked that question of the FDA at the last AABB conference in Miami and the response was that every institution is required to request a variance if they are going to issue thawed plasma up to 24 hours after thawing. I asked for the variance when I got back and just received the OK. I really don't understand why the FDA doesn't just issue a blanket approval so that it matches the Circular of Information and the Technical Manual. It would save everyone a lot of time.

Can you tell me how to apply for this variance?

You will be requesting a variance from 21 CFR 606.122(m)(3) in order to extend the storage time of thawed fresh frozen plasma at 1-6 C to 24 hours instead of 6 hours. Your request should consist of a letter stating the CFR reg as written and then how you want to deviate from it. You can state you want to align your hospital practice with the statement in the Circular, etc. You should state how you plan to label the product (new sticker, line through the word fresh...) and what you will do with the product after the 24 hours (discard, change to thawed plasma...) Also, print the form 356h from the FDA website and submit with your letter. Address your letter to:

Dr Alan E Williams, HFM-370

Center for Biologics Evaluation and Research

Food and Drug Administration

Suite 200N

1401 Rockville Pike

Rockville, MD 20852-1448

I got this information from our blood supplier and they were a great help in the 'how-to' department. Hope this helps.

Kathy

Or you could just change the labeling to "thawed plasma" at the time of initial thaw and save yourself the relabeling the product at 24 hours, as well as the hassle of a variance. This would also give you the flexibility to store this for 5 days at 1-6 C for quick issue if needed. We have been thru multiple FDA inspections with this product and never had any objections raised.

Per a recent article in January Transfusion (Comparison and stability of ADAMTS13 activity in therapeutic plasma products, Transfusion 2007;47:120-5), 5-day stored thawed plasma had basically the same levels of the enzyme as newly thawed & 24 hour thawed fresh frozen plasma. Other authors have found that therapeutic levels of the major clotting factors (>40% activity), even "labile" factors V & VIII, are also maintained in the stored thawed plasma. Just tailor your procedure such that this isn't the sole product given to Factor VIII deficient patients.

MJ

We also label as "Thawed Plasma" immediately after thawing. We have had no problem with FDA. It is labeling using the least common denominator (i.e. we are not calling a product something more than it is).

Why is it coming out now that the FDA wants a variance when people have been using a 24 hr outdate for 10 years?

Thanks for the info. I am having trouble finding labels that say "Thawed Plasma" rather than "Thawed Fresh Frozen Plasma". The only one I can find says "Liquid Plasma" (barcode 18501). Any suggestions?

We have been using Thawed plasma with a 5 day outdate for years. I don't know about you r blood supplier but ours doesn't make FFP any more, they make plasma frozen within 24 hours. Once thawed we take this right to a 5 day product and call it thawed plasma. We have a very aggressive prospective review policy and use the thawed plasma in situations where the INR is elevated. We ignore the PTT.

Mary, as far aas the labels go- We use Cerner classic still and they built a special program so the we generate barcoded labels from the computer. Before barcodes were required, we printed our own labels on a PC.

Is there or will there be an ISBT128 label for thawed plasma?

What is the barcode (codabar, not ISBT) for "Thawed Plasma"? The only one I can find in the catalog is "Thawed Fresh Frozen Plasma, 18900" which isn't in AABB's list of product codes dated March 2006.

Thanks!

Just one more question to all those that go straight to 'thawed plasma'....We have a mixture of plasma products from our supplier, many of which are apheresed. According to the AABB technical manual the expiration of apheresed plasma is 24 hours after thawing. Do you treat this product differently?

What is the barcode (codabar, not ISBT) for "Thawed Plasma"? The only one I can find in the catalog is "Thawed Fresh Frozen Plasma, 18900" which isn't in AABB's list of product codes dated March 2006.

Thanks!

We use Shamrock's THAWED PLASMA label (Codabar product code 29381)

For ISBT-128, I found quite a few. Here are some of the more common ones:

From CPD FFP: E26840

From CPD 24 hr plasma: E27010

From CPDA-1 FFP: E27020

From CPDA-1 24 hr plasma: E27190

From CP2D FFP: E27200

From CP2D 24 hr plasma: E27370

In Quebec, Canada we follow the Circular of Information, recently updated by Héma-Québec (the manufacturer) in 2005 that states frozen plasma may be stored for 12 months at - 18 degrees celsius or colder for 12 months, or at 1-6 degrees celsius for 24 hours after thawing.

MJ is correct. Go with Thawed Plasma, and you have no problem whatsoever, as the FDA does not regulate this product. The problem we have now with all this confusion was caused by the FDA. The regulation says transfusion of FFP must begin within 6 hours of thawing (not expire in 6 hours after thawing). The Circular of Information says FFP is good for 24 hours. The FDA approved the Circular of Information. So, everyone took this to mean they could now extend the expiration of FFP to 24 hours. To compound the issue, the FDA grants a variance request to anyone who asks to allow labeling Thawed FFP with a 24-hour expiration. So, I finally sent in my variance request last month and it was granted. In the meantime, since I became aware of the FDA interpretation, I labeled my FFP with a 6-hour outdate, then, at the end of 6 hours, converted it to Thawed Plasma with a 5-day post thaw outdate. I asked if I could get a verbal variance request (the FDA will do that on occasion, particularly when RBCs are at risk of being lost), but the Director said no, but they did allow me to fax my request to expedite the process.

So, I recommend biting the bullet and sending in the variance request (or convert to Thawed Plasma). I have attached my request. It works.

BC

FFP 24hr Variance Request.doc