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The appropriate response is not avoidance, but disciplined translational design that aligns mechanism, indication, and risk tolerance

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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