a herbal evaluation form, completed according to the instructions given in Appendix III, is appended to the submission:.

herbal non-medicinal ingredients, that are identified as being unacceptable, are not included (Appendix II):.

Information in the submission must support compliance as follows:

A drug submission for a product intended for oral use and containing herbal non-medicinal ingredient(s) may be accepted for review if compliance with the policy, and with other requirements, is confirmed.

In the case of two or more like-acting herbs, the pharmacological effects are considered to be additive and their combined activity must not exceed 10% for the same pharmacological action, based on the lowest documented therapeutic daily dose for each ingredient concerned.

The amount of a non-medicinal ingredient of botanical origin contained in the daily dose must not exceed 10% of the lowest therapeutic daily dose documented in traditional herbal literature.

Note that this list is intended as a guide only and is not necessarily all inclusive. Some herbs that are considered unacceptable in this regard are identified in Appendix II.

Only those ingredients of botanical origin that present negligible risk may be considered acceptable as non-medicinal ingredients in nonprescription drug products for oral use.

OL2975578W Page-progression lr Page_number_confidence 95.84 Pages 680 Pdf_module_version 0.0.20 Ppi 643 Related-external-id urn:isbn:0553201484

Access-restricted-item true Addeddate 19:31:39 Boxid IA146906 Camera Canon EOS 5D Mark II City Toronto Date-raw July 1982 Donorįriendsofthesanfranciscopubliclibrary External-identifier

The herb book by john b lust