FFP Labeling And 24 Hour Outdate

[bbbirder]

I am posting this for another BB supervisor, but I have the same questions..

When discussing the new labeling requirements, she contacted the FDA with some questions, and got this as a part of a reply:

"1) When Fresh Frozen Plasma (FFP) and Plasma Frozen Within 24 Hours (PF24) are thawed, they retain the FFP and PF24 product name on the label. Only the expiration date and time and storage temperature is revised.

2) These products may only be stored for up to 6 hours at 1-6 C. Storage of these thawed products at 1-6 C for up to 24 hours is a common practice but it requires approval of a variance under 21 CFR 640.120 to 21 CFR 606.122(m)(3). Consult our website for published variances: http://www.fda.gov/cber/blood/exceptions.htm

3) The thawed products are no longer FFP or PF24 after 6 hours (or 24 hours with a variance approval). If these thawed products will be used after 6 or 24 hours, the FFP and PF24 product name and license number must be removed."

My questions to you are:

1) Have you requested a variance for using thawed FFP beyond 6 hours?

2) Are you removing the name and license number when you use it for up to 24 hours (or 5 days, as some places do)?

Thanks

[Seveets]

I am posting this for another BB supervisor, but I have the same questions..

When discussing the new labeling requirements, she contacted the FDA with some questions, and got this as a part of a reply:

"1) When Fresh Frozen Plasma (FFP) and Plasma Frozen Within 24 Hours (PF24) are thawed, they retain the FFP and PF24 product name on the label. Only the expiration date and time and storage temperature is revised.

2) These products may only be stored for up to 6 hours at 1-6 C. Storage of these thawed products at 1-6 C for up to 24 hours is a common practice but it requires approval of a variance under 21 CFR 640.120 to 21 CFR 606.122(m)(3). Consult our website for published variances: http://www.fda.gov/cber/blood/exceptions.htm

3) The thawed products are no longer FFP or PF24 after 6 hours (or 24 hours with a variance approval). If these thawed products will be used after 6 or 24 hours, the FFP and PF24 product name and license number must be removed."

My questions to you are:

1) Have you requested a variance for using thawed FFP beyond 6 hours?

2) Are you removing the name and license number when you use it for up to 24 hours (or 5 days, as some places do)?

Thanks

We have been following AABB in regards to the 24 hour out-date for Thawed FFP WITHOUT a variance -- glad to see the FDA has finally followed suit. That list of published variances is a list of APPROVED Exceptions and alternative procedures that have been in place since April 28th so NOW NO variances will need to be granted.

We place a THAWED FFP label on top of the FROZEN label (no matter which product it is) which states the storage temperature and we change the expiration date and time.

After the 24 hours, the product would be labeled as THAWED PLASMA for up to 5 days, but we do not offer this and would throw out any Thawed FFP after the 24hours has elapsed.

We have never removed the name and license number of a facility from a product.

Also all this will change so how once ISBT128 goes into effect.

[bbbirder]

Here is more from the FDA:

(I am getting my pencil sharpened now to send in my written request.)

"I assume when you use the term 'approvals', you are referring to our list of exceptions that we have granted that is posted on our web site. Please make careful note that ALL of these exceptions are valid only for the single requestor that was actually granted the exception by CBER. Of course some of these exceptions have been granted more than once, but each of these was granted to a single entity.

You would make the request for a variance in writing. Submit this request to the Office of Blood Research and Review in CBER. The address is:

FDA/Center for Biologics Evaluation and Research

Office of Blood Research and Review

Division of Blood Applications

Suite 200N, HFM-99

1401 Rockville Pike

Rockville, MD 20852-1448"

[Seveets]

I wonder why they would publish this list then, if it only refers to the requesting party and is not an updated procedural thing? To show all of us what could be??

[TOBYCAT]

I talked to a individual at FDA about what to do she was very helpful.

Judy Ciaraldi 301-827-6147. Need to request approval to deviate from REg 21CFR606.122(m)(3) under provision of REg 21CFR640.12.

Request must be made by responsible person(Lab Medical Director/Director of Transfusion Service) Include name adress and phone number of cintact person.

Mail request to:

Allan E. Williams PhD

Director division of Blood Application

HFM-370

1401 Rockville Pike

Rockville, Md 20852-1448

She was very helpful

[Mary]

Which way is it? Need a variance or not?

[Kwenz]

THis issue has come up within our network. Our FDA inspector has never questioned the 24 hour expiration date. Has anyone received a definite answer on this? I find it hard to believe that virtually everyone in the country has been using 24 hours in violation of FDA rules.

[bbbirder]

I contacted the AABB about this, and asked if they would please clarify the 6-hour vs 24-hour dating issue with the FDA. Here is part of the response I got from the AABB:

I want to let you know that FDA is continuing to say that each facility must request a variance.

We do intend to keep this conversation active with FDA as we believe they should enact enforcement discretion until such time as they can update the Code of Federal Regulation. They have publicly acknowledged for a couple of decades now that the CFR should be updated to match what they know is current practice.

I know many (most?) facilities are using a 24-hour date (or longer) for FFP without a variance, and I know that many FDA inspectors must not be paying attention to this issue. We went ahead and requested the variance, to make sure we were 'legal' until the FDA puts in writing that this variance can be used by everybody, or changes the CFR.

Linda Frederick

[Julie]

ANOTHER PLASMA QUESTION: At what time do you all start the expiration? From the time the frozen product goes into the waterbath or when it comes out?

[Lcsmrz]

We start our timing when the bag is removed from the freezer, but before placing it into the waterbath, by changing the component from frozen to thawed in the computer system.

[Eagle Eye]

We do same. Change status in the computer after removing from freezer and before placing in the waterbath.

[Mabel Adams]

We do it when it comes out of the water bath.

[donellda]

We also do when it comes out of the waterbath. At my former place of employment we had to record when we placed it in the bath and that was the time that we used for expiration.