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Significant inflammation with endotheliitis can lead to disseminated intravascular coagulation (DIC), and thrombosis of small and large vessels with tissue necrosis or infarction

however, some evidence of degeneration, necrosis, and widened subgranular zones persisted

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If passed, these requirements would shift cGMP compliance for 503B facilities operating at scale from an episodic enforcement matter into a gatekeeper for whether new drugs can be compounded at all