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.
Posting the whole record, including the parts that do not flatter my decision.
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 enforcement dates were staggered by category — 503A first, 503B a few weeks later — because outsourcing facilities have manufactured inventory and clinic contracts to unwind while a 503A makes to order.
What I actually want to know is what actually distinguishes 503A from 503B, in terms of what each may make and from what starting material. I have searched first, so if this is covered somewhere point me at it and I will read it.
PharmHunterJen 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…
No disagreement with PharmHunterJen. One condition attached. 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.
Happy to go further on any of that.
PharmHunterJen 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…
I read this differently from PharmHunterJen, on substance rather than tone. A research-chemical supplier selling lyophilised powder labelled research use only is not compounding and is not claiming to. It is a different legal universe with no pharmacy oversight, no patient relationship and no content guarantee, and conflating the two in these threads helps nobody.
Happy to go further on any of that.
Sigma-Aldrich — Research-Grade Standards
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Shop Reference StandardsTaking the question as asked, rather than the general version of it. 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.
Ask again with the specifics and you will get a better answer than this one.
Dr.LipidDallas said:Resolution therefore closed the doors unevenly, and the asymmetry follows from the bulks lists.
Same pattern here, and in the same order. Nothing to add that would improve it.