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That last list is the "503A bulks list." Appearing on it is a compounding-eligibility decision — it is not FDA approval of a finished drug, which is an entirely separate pathway

Mists

Mass:10ml

What the FDA Review Could Mean If PCAC recommends Emideltide for inclusion on the 503A Bulks List and the FDA acts on that recommendation, compounding pharmacies would have a clear legal path to dispense DSIP for patient-specific prescriptions