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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