503B outsourcing facility
Where a compounded drug parts company with an FDA-approved one, where 503A parts company with 503B, and which accreditation programs tell them apart.
Definition
An FDA-registered outsourcing facility that can compound in larger volumes without a patient-specific prescription. It is inspected by FDA and held to full cGMP, which is a materially higher bar than a 503A. Naming a 503B partner is one of the strongest disclosure signals a seller can offer.
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