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Note the launch of LillyDirect as an example of a branded, regulated pharmaceutical company going direct-to-consumer (DTC) beyond advertising to provide a service platform focused on obesity and weight management

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Key Takeaways On April 1, 2026, FDA issued astatementreminding 503A pharmacies and 503B outsourcing facilities that compounded drugs qualify for the statutory exemptions under the Federal Food, Drug, and Cosmetic Act (FD&C Act), only when applicable conditions are satisfied, with specific focus on the essentially a copy standard.

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