Did you know??

[hmust1]

FYI - for small hospitals/tranfusion services...even though my tiny non-FDA registered hospital aliquots packed cells about once every five years or so...

I found out yesterday that anyone implementing ISBT 128 bar codes who also labels any red cell products (including a red cell aliquot) needs to request a variance to FDA regulation 21 CFR 606.121. Here's the information I got from matt@cber.fda.gov:

"Please be advised that if you are converting from Codabar to ISBT 128, you should apply for variance to 21 Code of Federal Regulations (CFR) 606.121(e)(1)(ii) which will allow you to print the anticoagulant name after the product name instead of preceding it. You will need a variance prior to using ISBT 128. The variance is required regardless of whether the facility is registered-only or not. We do not require that registered-only facilities submit labels for prior approval; but a variance to use ISBT is required at this time since it conflicts with the regulations as currently written. All blood establishments are required to comply with the "bar code rule" which was effective April 26, 2006."

Mail your request for variance to:

Center for Biologics Evaluation and Research

Attn: Division of Blood Applications (DBA)

HFM-375, Room 200N

1401 Rockville Pike

Rockville, MD 20852-1448

[rcurrie]

Yes, I knew that, but then you knew that I knew that. ;-)

But, I always say go to the horse's mouth to make sure. I talk to good ole Matt all the time.

Attached is what works to obtain a variance for ISBT 128.

BC

ISBT 128 Variance Request2.doc

[Mabel Adams]

And what will happen to the little non-registered transfusion service that does not apply for a variance?

Most of them seem to be necessary because FDAs regs aren't up to date.

[rcurrie]

As we say in the legal world, ignorance of the law is no excuse. The usual pattern of FDA enforcement is to issue a 483, then a warning letter, then place the institution under a consent decree, then padlock the doors. It happens.

As far as "being up to date," a regulation is in force until it is superceded, repealed, ruled void, or found to be Unconstitutional. The FDA has no great pressure to keep up to date; it's their ball, so they make the rules. Interestingly enough, a regulation can be found void for vagueness (quite a common defense) or unenforceable due to a history of lack of enforcement with known violations. If I were to challenge the 24-hour FFP variance requirement, it would be on the ground of "unenforceability due to a history of lack of enforcement with known violations."

BC

[bmarotto]

I am also aware of the need for a variance. Does anyone know how long it takes to obtain? We will convert to ISBT-128 when our blood center (Red Cross) does. It has already been delayed several times; the last I heard they are aiming for March 2008. Do you have to implement ISBT-128 within a certain time after receiving the variance? If not, I may just go ahead and submit my request now.

[rcurrie]

Go ahead and request it now. You don't have to implement until you are ready. My guess is it will take 2 weeks to a month. Mine took a little over a week, but I have a close connection in the FDA- someone I went to law school with. I was able to fax my request and it was on the director's desk the same day.

BC

[Seveets]

As far as "being up to date," a regulation is in force until it is superceded, repealed, ruled void, or found to be Unconstitutional. The FDA has no great pressure to keep up to date; it's their ball, so they make the rules. Interestingly enough, a regulation can be found void for vagueness (quite a common defense) or unenforceable due to a history of lack of enforcement with known violations. If I were to challenge the 24-hour FFP variance requirement, it would be on the ground of "unenforceability due to a history of lack of enforcement with known violations."

BC

Anyone hear anything new about the variance requirement for ISBT or for keeping THAWED FFP for 24 hours?

[Franklyn]

The AABB website has a nice form letter for requesting the ISBT variance. Just fill in your information, sign it and send it.