Hims & Hers began offering a compounded pill version of Novo Nordisk’s Wegovy shortly after the FDA approved the branded oral formulation, prompting immediate industry and regulatory scrutiny. The telehealth company said it would provide an alternative compounded product to patients; Novo Nordisk signaled potential legal action, calling such copies "unapproved" and "inauthentic." FDA Commissioner Marty Makary publicly warned the industry that the agency would "take swift action" against companies mass‑marketing unapproved copycat drugs. For clinicians and payers, compounded versions of complex biologic‑derived or specialized small‑molecule regimens raise questions about manufacturing standards and regulatory compliance. Compounding pharmacies can legally prepare individualized medicines, but large‑scale commercialization of compounded therapeutic equivalents sits in a gray area of enforcement and litigation risk.
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