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Commissioner Makary stated: "Compounded drugs can be important for overcoming shortages or meeting unique patient needs, but compounders should not try to compound drugs in a way that circumvents FDA's approval process." While these targeted injectables, not herbal patches, the regulatory direction is clear
The direct claim asserts that Hims's compounded products contain semaglutide and fall within at least claim 1 of the '343 patent, while the inducement theory targets Hims's role in coordinating with API suppliers, compounding pharmacies, prescribers, and patients, citing a YouTube video titled "How to Take Compounded GLP-1 Injections" as evidence of active encouragement
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