From: Trish Flaster [Tflastersprint@earthlink.net]
Sent: Saturday, August 09, 2003 9:05 AM
To: fdadockets@oc.fda.gov
Subject: docket#1996N-0417

THank you for making comments available by email.

I have two points concerning GMPS.  One is that AHP, American Herbal 
Pharmacopeal should be recognized as an authority. AHP has written more 
relevant monographs with the most current methods than USP and any 
other Pharmacopeal group in Europe etc.

Second it is critical as you have stated for raw materials that 
botanical identification also be required for all plant products.  The 
paper trail must refer to an annotated, botanical vouchered specimen 
with corresponding bulk raw materials of the part of the plant in use.  
This bulk will need characterization and have been extracted and used 
as a comparative for identification.  It is not necessary to have a new 
botanical voucher as a reference for each extract if one is in place 
with direct linkage to the original plant sourced.

No extract or processed plant materials can be identified without a 
vouchered specimen.  That for sure need to be required as TLC or other 
chemistry methods cannot not identify plants.

Trish Flaster, Executive Director
Botanical Liaisons, LLC
1180 Crestmoor Drive
Boulder, CO 80303
303-494-1555, 303-494-2555 FAX
www.BotanicalLiaisons.com