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.
Answering this needs the jurisdiction, since this two-tier structure is a feature of one national framework and does not translate directly elsewhere.
Beyond-use dating differs by category and by the preparation environment, and an unusually long date on a compounded sterile preparation is worth asking about.
Put another way, adverse event reporting obligations attach to the outsourcing category and not to the patient-specific one, which is a real difference in the information that exists about what a facility produces.
Current good manufacturing practice applies to the outsourcing category and not to patient-specific compounding, which is the substantive regulatory difference.
A registration category describes obligations, not the quality of any particular preparation.
The category tells you which standards apply, not how good the preparation is.
3Sharing records with the usual clinician is the advice I ignored and should not have. – retest_please 8 months ago 4Thank you — treating this as a paperwork problem with a paperwork solution reframed it for me. – w_okoye 10 months ago add a comment