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FDA Commissioner Marty Makary stated: "When FDA-approved drugs are available, outsourcing facilities cannot lawfully compound using bulk drug substances unless there is a clear clinical need." What this means for 503B facilities: If finalized, this proposal would permanently close the large-scale outsourcing facility compounding pathway for these three medications - regardless of future shortage conditions

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The KwikPen contains four fixed doses and is available in dosages ranging from 2.5 mg to 15 mg allowing flexible, personalized dosing

It's because the price difference is paying for downstream infrastructure that doesn't exist on the research side

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