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  • The challenges for 340B covered entities attempting to comply with the orphan drug exclusion are two-fold:  First, the list of orphan drugs issued by HRSA is description-based, and does not include NDCs necessary to definitively identify which drugs carry the orphan exclusion and should therefore be excluded from the program.  Second, a covered entity wishing to obtain 340B pricing on orphan-designated drugs used for non-orphan conditions must match the dispenses of the drug against patient diagnoses to identify the context of “usage”.