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FDA Regulation Question
Hey everyone! Do R&D-only labs need to be registered or adhere to specific requirements when formulating OTCs (specifically sunscreen)? I know contract manufacturers have to register with the FDA, conduct SPF testing, and follow strict guidelines, but I am curious if there are regulations put in place for actual R&D labs that do not conduct manufacturing. I formulated a men’s facial moisturizer and want to include some SPF, but I would like to contract a chemist to add that component to the formulation. The companies that I’ve contacted only do custom formulations. So, I’d have to outsource a contract manufacturer upon completion of the formula revision. I just want to make sure things are done right. Thanks in advance.
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10 Replies
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Will the R&D lab be making product for human use/application?
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Yes, it will be for human use. They will only be adding the SPF component to the formula, but not actually mass producing it. I would have to source a CM for production.
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CM as an FDA reg facility in GMP control and product within monograph??
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Yes
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Your Formulator doesn’t have to be FDA Registered. They should however have experience with OTC products, the monographs, OTC documentation standards, and other specific tasks. Sunscreens are deceptively easy. There is far more to it than simply adding SPF to a product.
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Roger that. Thank you for the info.
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Supply lab with base formula under NDA and let them know desired SPF and specify zno and tio2 as sunscreens to use
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Hi @Ron_93,
If you’re in the market for a CM with an R&D lab to help develop this formula you can PM me and I’ll see if our company can be a good fit for you. We’re located in southern Florida and have experience formulating and manufacturing SPF products and other OTCs.
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The proposed MoCRA will change all of this.
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No - this is a drug question. MoCRA only addresses cosmetics and does not impact development labs
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