Use of FFP anf FFP24(FFP frozen within 24hrs)

[Eagle Eye]

Do you use FFP and FFP24(FFP frozen within 24 hrs) interchangeably ? Do you use FFP24 up to 5 days after thawing?

[bmarotto]

We use them interchangeably but use a more conservative up to 3 days post-thaw.

[donellda]

We currently are not set up to use FFP24.

[Seveets]

We used to.

Now we have extended the outdate to 5 days but only for FFP so that is what they are buying.

[TexasMarty]

We use FP24 interchangebly with FFP except we do not use it for neonates.

We extend the outdate to 5 days post thaw. It, like FFP, then becomes thawed plasma. Today I found out that we have to send a letter to FDA (like the ISBT 128 letter), but that's all the information I have right now.

[stephanie sephel]

We use FP24 interchangebly with FFP except we do not use it for neonates.

We extend the outdate to 5 days post thaw. It, like FFP, then becomes thawed plasma. Today I found out that we have to send a letter to FDA (like the ISBT 128 letter), but that's all the information I have right now.

Can you expand on the FDA requirement to expand the FFP24 to 5 days? Do you have the reference for that?

[TexasMarty]

An assessor told me this last week. We'll probably find out more on the AABB web site.

[rcurrie]

Under federal regulations for frozen plasma products, your Circular of Information must contain "instructions to begin administration of the product within 6 hours after thawing." (See 21 CFR 122(m)(3)) There is no federally mandated expiration that must be assigned to thawed plasma products. However, in order to comply with the regulation above, we (the blood banking industry as a whole) always assigned a 6-hour outdate to thawed plasma products. However, in the last dozen or so years, the FDA has allowed those institutions who submit a request for exception (variance request) to label the units with a 24-hour hour expiration. The regulation is in contradiction with the FDA-approved Circular of Information (July 2002). The Circular of Information (CIO) says, "Thawed FFP should be infused immediately or stored at 1-6 C for up to 24 hours. If stored greater than 24 hours, the words 'fresh frozen' must be removed." The approval of the CIO by the FDA implied to most people (and reasonably so, I might add), that the FDA had granted a variance to all comers to store FFP for up to 24 hours. The FDA and the blood banking industry have been engaged in a "don't ask, don't tell" situation for many many years over this issue. Well, someone finally asked (in the 2006 Ask The FDA session of the AABB Annual Conference). So, the FDA said it is 6 hours unless you submit a request for exception under 21 CFR 640.120. The FDA does not differentiate between FFP and plasma frozen within 24 hours of collection (so-called FFP24). The requirements stand for both products. If you want to store FFP24 for up to 24 hours, you must submit a Request for Exception, otherwise known as a variance request. As far as extending the storage to 5 days and labeling it as Thawed Plasma, the FDA does not license or regulate this product. AABB says you can store it for up to 5 days.

I hope that clears up some of the mystery.

BC

[rcurrie]

Step 2:

For those of you who wish to now come into compliance with federal regulations (assuming you are labeling thawed FFP with a 24-hour outdate in violation of such federal regulations), here is the wording of my Request for Exception, for which I was granted a variance from the regulation:

Department of Health and Human Services

Center for Biologics Evaluation and Research

Food and Drug Administration

1401 Rockville Pike

Rockville, MD 20852-1448

ATTN : Alan Williams, Ph.D.

Re : Request , under 21 CFR 640.120, for Exception to 21 CFR 606.122(m)(3) to Extend the Storage Time of FFP to 24 Hours

This letter is official notification from <<name of institution>>, Facility Registration Number <<FEI>>, of our request, under 21 CFR 640.120, for an exception to 21 CFR 606.122(m)(3) to extend the storage time of Fresh Frozen Plasma (FFP), thawed at 30 to 37ºC and stored at 1 to 6ºC, to 24 hours, instead of 6 hours.

[leslieweber]

Hi

Re letter to FDA for 5 day plasma - what is this? Can someone send me the reference that describes this requirment?

Thank you

[rcurrie]

It is not a letter- it is a regulation. The regulation is 21 CFR 606.122(m)(3). This regulation basically requires a 6-hour outdate on FFP. The FDA will grant a variance to allow an institution to label FFP with a 24-hour outdate, but there is nothing that allows you to give FFP a 5-day outdate. Rather, you can call it Thawed Plasma (but not Thawed FFP). The FDA does not regulate Thawed Plasma, so has no problem with a 5-day outdate on this product.

BC

[ffriesen]

We use interchangably up to 24 hours.

[bmarotto]

We compromise and give all our thawed plasma a 3 day outdate and use it interchangeably with FFP. We use a lot of plasma due to a very active hepatobiliary and liver transplant service. We find with 3 day dating, we almost never outdate thawed plasma so there is little reason to extend the dating to 5 days.

[irshadaad]

we use thawed ffp upto 24 hrs only after thet we labl it as plasma with 5 days expiry

[Ral]

I may be totally off base here...but this is how I understand it:

- FFP must be frozen within 6 or 8 hours (vendor specific) - From Whole blood or apheresis

- FP24 is whole blood plasma frozen withing 24 hours of collection

- PF24 is apheresis plasma frozen within 24 hours of collections - the FDA does not recognize this product.

- I don't know the regs. on when FFP or FP24 labeling changes to liquid plasma.

- the 24 hour \ 5 day outdate is dependent on the collection method. All WB and some Apheresis plasma are collected in a closed system and therefor carry a 5 day outdate. Some apheresis plasma is collected on older technology which is open system plasma and must be utilized or discarded within 12 hours of thaw.

Hope this has added something to the conversation, besides confusion.

[tcoyle]

We also use FFP/FP24 interchangeably. We do not extend (to 5 days) the outdate on apheresis plasma as our system to collect is considered open. Our computer system is set to control this so that we cannot inadvertently thaw an apheresis unit with an extended outdate.