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10.1371/journal.pgen.1000504 PLoS Genet
Under Section 503B, outsourcing facilities may not compound drugs that are essentially copies of one or more approved drug products, and they are prohibited from compounding using bulk drug substances unless the substance appears on FDA's 503B bulks list or the drug appears on FDA's drug shortagel at the time of compounding, distribution and dispensing
What Hims failed to tell investors was Hims marketed compounded semaglutide from unapproved Chinese suppliers, not Novo Nordisks authorized chain
The sterility is compromised after the first use, raising infection risk
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