I have a client who formulated a topical cream. They used 0.625% pantothenate (aka Vitamin B5) in the formulation as a functional excipient to enhance solubility as a weak acid. I don't see it in FDA's excipient database, but have found Bayer's Bepanthen Cream sold OTC in France has 5% pantothenate in it and that back in 1978 FDA's Select Committee on GRAS Substances declared it safe. So:
1. Is there any alternate database to refer to levels of specific excipients in products for safety, other than the IIG database the FDA currently uses? And if not …
2. What is the official, or best way to declare an old, unlisted excipient, to avoid a RTR from FDA's OGD division where there's no DMF to reference, it's a B vitamin and declared safe by an FDA committee back in 1978?
Perhaps go in with a Controlled Correspondence first?
Thanks for any suggestions.
Chris
Christopher Smith, CQE, RAC
President, Coastal Pharmaceutical Consultants, Inc. ®
7950 Old River Road, Burgaw, NC 28425 USA
910-259-8877 (land)
910-789-1232 (mobile)
chrissmith@coastalpharmaconsultants.com