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May 2001


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"Faulkner, Arthur J" <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Mail List <[log in to unmask]>
Wed, 2 May 2001 10:49:42 -0400
text/plain (85 lines)
Scott, thanks for your response.  The following is taken from a slide that
you presented regarding review of microbial regulations/AET:

        FDA must detail a mechanism for handling grandfathered products.

        In the absence of protection, USP cannot agree to "regulate" safe
and effective products off the market

        In the presence of protection, USP is inclined to accept EP criteria

The third point was somewhat concerning, but it sounds as though there is
not a significant effort to harmonize the acceptance criteria.  Thanks again
for your input.

Art Faulkner

-----Original Message-----
From: Scott Sutton [mailto:[log in to unmask]]
Sent: Tuesday, May 01, 2001 6:46 PM
To: [log in to unmask]
Subject: Re: [PMFLIST] PET criteria

Okay, since no one else is going to touch this one I will answer it.

The methods are "essentially harmonized."  The criteria may not be
without some compromise on the European side (unlikely, as little or
no desire to compromise has been evident to date from the European
side).  The USP probably will not accept the more stringent EP
criteria because there is no compelling reason to do so.  In other
words, no one has been able to make a believable case that there is a
problem with products on the US market that acceptance of the EP
criteria would fix.

In addition, if the USP were to move to more stringent requirements,
then the FDA could well consider itself obligated to enforce these
criteria against products currently on the US market.  Many of these
products would not meet the more strigent expectations and might well
be subject to recall.

The USP is thought to be unwilling to regulate products off the market
for no measureable gain in safety or efficacy.

Scott Sutton

On Tue, 24 Apr 2001 08:39:11 -0400, you wrote:

>Can anyone provide an update on the harmonization of the preservative
>efficacy test through PDG.  I understand that the test methods are
>considered essentially harmonized, however the acceptance criteria are very
>different.  I've heard that USP may consider adopting the more stringent
>Eur. Criteria.  What is the current status of this proposal to harmonize
>acceptance criteria?
>Art Faulkner
>The PMFList ( is operated from
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The PMFList ( is operated from
The Microbiology Network ( and supported by
our sponsors ( as a service to
the scientific community.

The PMFList ( is operated from
The Microbiology Network ( and supported by
our sponsors ( as a service to
the scientific community.