Taking the question as asked, rather than the general version of it. Resolution therefore closed the doors unevenly, and the asymmetry follows from the bulks lists. For 503B the shortage clause was the only route to these molecules, so that route shut completely. A 503A pharmacy can still argue a doorway via "component of an approved drug" — but only for the substance in the form present in the approved product, which is exactly where the base-versus-salt argument lives, and it does nothing about the copy restriction, which came back into force on resolution.
Two pharmacies quoted me last year, one describing itself as 503A and one as 503B, and I assumed 503B just meant bigger until both stopped within weeks of each other.
Two things anyone can check: a state licence number for a 503A, and an FDA outsourcing-facility registration for a 503B. Both are publicly searchable, and a pharmacy unwilling to give you either has answered the question.
The narrow version of the question is why a shortage listing created a legal pathway at all, since a shortage is a supply fact rather than a permission.
Tell me what I have not thought of.
Dr.ObesityMed said:Resolution therefore closed the doors unevenly, and the asymmetry follows from the bulks lists.
Agreeing with Dr.ObesityMed, and the qualification matters more than the agreement. Worth adding the genuine exception, because it is real and narrow: a change made for an identified patient where the prescriber determines it produces a significant clinical difference for that patient. A grid of fixed doses offered to everybody is not that, whatever the intake form says.
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Shop Reference Standardssophie_paris said:Two pharmacies quoted me last year, one describing itself as 503A and one as 503B, and I assumed 503B just meant bigger until both stopped within…
Same position here, arrived at the long way round. The shortage clause is the answer to the second question and it is a subtraction rather than an addition. Both exemptions forbid compounding something that is essentially a copy of a commercially available approved product. A product FDA has listed as in shortage is not treated as commercially available, so listing removed the objection that otherwise blocked compounding. It never created a permission; it withdrew a prohibition, which is why it evaporated the moment the supply fact changed.
Adding the clinical framing, because it changes how the question reads.
Compounding pharmacy customer here with experience relevant to compounded supply.
I've ordered from 4 different compounding pharmacies over the past 14 months. The quality variation is real — purity ranged from 94% to 101% of label claim based on independent Janoshik testing.
My current compounder (a 503B facility) has been consistently 98-101% purity across 8 orders. I pay $135/month vs $1,365 for brand. The savings are substantial and the product is equivalent in my experience.
Re: compounded supply — this applies whether you're using brand or compounded. The clinical principles are the same.