Looking at several guidance documents and sites, I found it confusing of whether you can use a GRAS substance as a excipient.
For instance, Guidance for Industry Investigational New Drug Applications (INDs) - Determining Whether Human Research Studies Can Be Conducted Without an IND, stated,
"If a product containing substances generally recognized as safe (GRAS) for use in food is administered to subjects in a study intended toevaluate the effect ofthe substance on the pathogenesis of a human disease, is an IND required?
Substances designated as GRAS for use in food are not approved as drug products. A clinical investigation of a GRAS substance that is intended to evaluate the product's ability to diagnose, cure, mitigate, treat, or prevent disease requires an IND under part 312, unless the substance to be studied is also a lawfully marketed drug and the clinical investigation meets the criteria for exemption under 21 CFR 312.2(b)."
My excipient has GRAS status, but it is not on the approved Inactive Substance database. Does it mean it is considered as a "novel excipient"?
But on this site
http://www.barbfeick.com/vaccinations/allergy/605-1gras.html It says Excipient is "approved" by one of these 3 pathways
1. determination by FDA that the substance is "generally recognized as safe" (GRAS) pursuant to Title 21, U.S. Code of Federal Regulations, Parts 182, 184 or 186 (21 CFR 182, 184 & 186);
2. approval of a food additive petition as set forth in 21 CFR 171; or
3. the excipient is referenced in, and part of, an approved new drug application (NDA) for a particular function in that specific drug product.
Isn't the GRAS status only pursuant to its intended use i.e. Food additive GRAS substance for use in Food, but not in drugs?
Your input will be greatly appreciated.
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Lewis Lau
Cynapsus Therapeutics
Toronto, ON
Canada
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