2000D-1392 - BOTANICAL DRUG PRODUCTS
FDA Comment Number : EC5
Submitter : Miss. Anna Choy Date & Time: 09/24/2004 02:09:10
Organization : Shanghai Comman Pharmaceutical Co., Ltd
Drug Industry
Category :
Issue Areas/Comments
GENERAL
GENERAL
In the 'Guidance for Industry-Botanical Drug Products' which is issued in June 2004, the 2nd part 'II. Background' states that the 'Highly purified substances (e.g., paclitaxel)' is not included in the botanical products.

We would like to know if there is any specific limit for the 'highly purified substance'? Which purity could be classified as 'highly purified' and which could be not?

Do the limits apply to both botanical drugs and botanical dietary supplements? If there is any reference, please let us know.

A quick response is highly appreciated. Thanks and best regards.