request for variance before implementing ISBT

[BBKT]

Anyone heard about this one? 21 CFR 606.121(e)(1)(ii) states that the anticoagulant must appear before the proper name of the product. With ISBT 128 standards, the anticoagulant appears below the proper name. Does this mean I will need to request a variance when we start using ISBT products and we relabel when dividing?

[rcurrie]

The short answer is yes, but the long answer is that the FDA plans to change the regulation so that a variance is not required. You may be able to hold your breath long enough for the FDA to publish the new rule in the Federal Register. If you can't hold your breath that long, then feel free to use what worked for me when I requested a variance. Turnaround time is about 2 weeks from the FDA.

BC

ISBT 128 Variance Request2.doc

[lehooke]

I work at a small Transfusion Service at a community hospital. In the next few months, we will be converting to ISBT 128 and I need to know if we are required to send a letter to the FDA requesting a variance for conversion to ISBT 128.We do not relabel, pool, modify or collect products at all. I have seen a sample of the letter on this forum and wondered if this applied to all hospitals/ transfusion services or only those who relabel products. I spoke with a representative from the AABB and she thought this did not apply to us, but I want to be sure. I would appreciate any advice you all may have. Thanks!

[Mary]

Ask the FDA at matt@cber.fda.gov

[Franklyn]

A variance is still required (at this time) because the location of the anti-coagulant on the ISBT 128 label is in the wrong position as specified in 21 CFR 640.120

[Lcsmrz]

Sites that do nothing other than thaw FFP and Cryo do not need to be registered with ISBT-128 or obtain a label printer to generate labels. We eliminated aliquotting units and pooling products from our SOP to reduce the cost of implementation.