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From:"Peter A. Takes" <> (by way of histonet)
To:histonet <>
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You won't find instructions or protocols for extending expiration dating in 12
CFR 809 or 864.  Nor will FDA help in this regard...that's something they
preach against.

>From a technical standpoint, yes, most non-diluted (i.e., neat concentrated)
reagents will last and be viable for extended periods (years) under frozen
storage when aliquoted.  Even some diluted reagents.  I believe organizations
like HCFA & CAP may allow the use of such reagents after the
manufacturer-specified expiration date has passed, but require that individual
labs seeking to use such reagents do their own revalidation of the antibody's
efficacy.  In the event of ASRs, you will have to do this anyway for "within
expiration date" reagents, since, by rule, manufacturers cannot promote or
endorse specific uses as having been validated or as appropriate if the
antibody is labeled as an ASR.

Individual manufacturers can tell you how to store and the theoretical extended
life possibilities for their products.  However, if they formally endorse such
extensions for IVD or ASR products, there are a number of FDA labeling issues
that can result in controversy for the manufacturer.  Most will give you
general (not product-specific) guidelines, and tell you to pursue revalidation
for any reagents you choose to use in this manner.

Hope this helps to answer some of the questions.

Peter A. Takes, Ph.D., RAC
Director, Clinical & Regulatory Affairs
Ph. 1-314-615-6964; Pager: 841-9351


> Dear Histonetters,
> Would appreciate input on the use of expired immuno reagents/antibodies.
> I am under the impression that some of us may aliquot and freeze
> antibodies thereby extending their "life" beyond the expiration date
> and some may use properly stored antibodies after expiration...both
> practices and perhaps other combinations are then always quality assured by
> running appropriate controls that validate results.
> I've researched 21CFR809 and 21CFR864 as these were the codes that were
> applied to the recent FDA ruling on Analyte Specific Reagents (ASRs). I
> can find nothing that addresses this specific subject. I called the
> FDA and their position is that there is no data to support the use of ASRs
> beyond the expiration date and therefore they are not to be used.
> So...what do my friends in Histoland think and do regarding this practice.
> Inquiring pathologist and histologists minds want to know :-)
> Thank you.
> Yvonne Thompson, VA Medical Center, Bay Pines, FL.

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