Accepted answer
Section 503A is an exemption, not an approval, and it is conditional on four things. A patient-specific prescription; a licensed pharmacist or physician doing the compounding in a licensed facility; bulk substances that either have a USP monograph, appear on the FDA's 503A bulks list, or are components of an approved drug, each with a certificate of analysis from a registered supplier; and the preparation must not be essentially a copy of a commercially available drug. That last condition is the one that moves: it turns on the shortage list, and what was lawful under 503A while a product was in shortage stops being lawful when the shortage is resolved. None of the four requires the finished preparation to be tested, which is the gap that independent assay fills.
Start with which category a facility is registered under, because it is a matter of public record and it tells you what it can legally do.
Outsourcing facilities may produce without a patient-specific prescription, register federally, are inspected on a risk-based schedule and are subject to current good manufacturing practice.
Neither category produces an approved product. Both operate outside the marketing-authorisation framework, and the difference is in the manufacturing standards applied, not in approval status.
Current good manufacturing practice applies to the outsourcing category and not to patient-specific compounding, which is the substantive regulatory difference.
Neither category yields an approved product, and the distinction is often blurred in marketing.
The category tells you which standards apply, not how good the preparation is.
6Is the beyond-use date something a facility will state on request? – tobias_maartens 17 days ago 7This is the clearest description of the two-tier structure I have read. – vial_five 2 months ago add a comment