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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

That is more than the company spent on research and development over the past three decades combined, undermining arguments by Big Pharma that high prices are needed to convince companies to invest in R&D

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