Susan,
Thank you very much for your comment. Does this mean that we need to look for another manufacturer that would have the actives we use and are registered? I am asking because I spoke with the current manufacturer we use and I was told that their products do not need to be registered because it is an excipient and also because it has been used and never needed to be registered since the 50s. We get Dimethicone NF and Zinc Oxide (ZOCO 103 USP) from them which we use in our OTC skin protectant (which has an NDC #). I even showed them the monograph for OTC skin protectants showing them that their products fall under “actives”. They said that I will not find any manufacturer that sells these chemicals and is registered and listed if it is used for OTC skin protectants.
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Olufunke Bundo (Olu)
Frisco TX
United States
Original Message:
Sent: 22-Sep-2016 13:14
From: Susan Crane
Subject: APIs used in OTC skin protectants
Dear Olufunke,
If the ingredient is being used in an OTC skin protectant drug product as an active ingredient, the facility must be registered (21 CFR 207.17) and the drug must have an NDC (21 CFR 207.33) and be listed (21 CFR 207.41). This is very clear in the recently updated Establishment Registration and Drug Listing regulations.
If the ingredient is strictly being used as an excipient (as in a cosmetic), the registration and listing requirements would not apply.
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Susan Crane
President
OTC Compliance, LLC
Johns Creek GA
United States
Original Message:
Sent: 21-Sep-2016 23:29
From: Olufunke Bundo
Subject: APIs used in OTC skin protectants
Hello All,
I am looking for information to show why a manufacturer may not have chemicals listed (NDC #) and also not have their facility registered (FEI #). The chemicals can be excipients being used as actives in OTC skin protectants. Such as Zinc Oxide USP, Dimethicone (NF), Petrolatum. I know there is an exemption in 21 CFR 207.10 but I do not think it applies to them. Could they be considered atypical actives? If yes, is there any regulation that covers the manufacturer not listing them? Thank you.