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  • However, section 340B(e) of the PHSA does not exclude from the 340B Program drugs that are transferred, prescribed, sold, or otherwise used for conditions or diseases other than for which the drug was designated under section 526 of the FFDCAWhat is orphan designation?View AnswerA drug is designated by the FDA as a drug for a rare disease or condition pursuant to section 526 of the FFDCA at the
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