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From:
Carol Lydick <[log in to unmask]>
Date:
Sat, 27 Jun 1998 20:55:52 EDT
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<<Disclaimer: Verify this information before applying it to your situation.>>

I was speaking with a research scientist, from Warner Chilcot
Pharmaceutical Company, who is researching the GF status of a cholesterol drug
for me made by that company.  He appeared very knowledgeable about the problems
of fillers in drugs.   He reiterated, (information that most of us know at this
point), the problem of companies buying fillers from many sources and if there
is a delay in receiving an order from one company during the production
of a drug, the drug company will switch to another.  They have no way of
knowing the ingredients the supplying companies may have included in the mix or
whether the ingredients are grown on a gluten product.  Also the actual
manufacturing of a drug is often contracted out to other companies for
production, further complicating the issue of ingredients.

I mentioned that we were trying to get the FDA to control ingredient
labeling in food and drugs.  This gentleman stated that he felt, that on
this issue, we were dealing with the wrong people.  He felt that the USP,
or U.S. Pharmacopeia was the right agency to approach on these issues.
That it is the USP that dictates the regulations developed in the
manufacturing of drugs and serves many other functions in the pharmaceutical
community.  Whatever they recommend, the FDA usually supports.  He therefore
recommends that we bring our issues to the USP.

I have been trying to find the USP on the internet, but so far have had
no luck.  Anyone out there have any opinions or knowledge about the USP?
Has anyone from the CSA or other groups been in contact with this
organization?

Carol in NJ

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