Re: EXPIRATION DATE
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From: | "Peter A. Takes" <ptakes@stereotaxis.wustl.edu> (by way of histonet) |
To: | histonet <histonet@magicnet.net> |
Reply-To: | |
Content-Type: | text/plain; charset="us-ascii" |
Please note: My message should have read 21 CFR 809 or 864, NOT 12 CFR 809 or
864. Sorry for any confusion.
Peter
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
>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
> --
> Peter A. Takes, Ph.D., RAC
> Director, Clinical & Regulatory Affairs
> STEREOTAXIS, Inc.
> Ph. 1-314-615-6964; Pager: 841-9351
> ptakes@stereotaxis.wustl.edu
>
> THOMPSON.YVONNE_M@BAY-PINES.VA.GOV wrote:
>
> > 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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