After reaching out to a few folks and getting their ideas and re-reading the FDA information, I do not believe you are precluded from submitting any substance to be included on the list of bulk drug substances that may be used to compound drug products. Any substance that you would like to be included on the list should be submitted to the FDA for consideration. So to answer the specific question posed, you are free to submit Estriol to be included on the list. If the FDA decides to include Estriol or any other substance on a proposed list, other stakeholders will have an
opportunity to comment on the proposal and then the FDA will issue a final
determination.
1 comment:
Thanks for the reply! The FDA might say "No way!" (as estriol has never been in an FDA approved drug, and might not want to set precedent). But, if they reassured the holistic community of doctors and patient advocates (Suzanne Sommers, etc) by signaling that estriol was not going to be banned, then there wouldn't be the pushback when the FDA goes after the dangerous things (e.g. bHRT pellets thst have an unreliable rate of dissolution, etc.).
Kenneth Woliner, MD
www.holisticfamilymed.com
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