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From:"Peter A. Takes" <> (by way of histonet)
To:histonet <>
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Please note: My message should have read 21 CFR 809 or 864, NOT 12 CFR 809 or
864.   Sorry for any confusion.


Peter A. Takes wrote:

> Yvonne:
> 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
> 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
> life possibilities for their products.  However, if they formally endorse
> 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
> for any reagents you choose to use in this manner.
> Hope this helps to answer some of the questions.
> Peter
> --
> 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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