This is the version of the explanation I wish somebody had given me, written down before I forget what confused me. It is about compounded supply, and it is deliberately narrow — everything I am not confident about is marked as such.
What is actually established
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.
The condition it depends on
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.
The practical version
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.
What I am not sure about
What I am trying to establish is what actually distinguishes 503A from 503B, in terms of what each may make and from what starting material. Practical detail welcome, however dull — the duller the better.
KevinCompounds said:Resolution therefore closed the doors unevenly, and the asymmetry follows from the bulks lists.
Agreeing with KevinCompounds, and the qualification matters more than the agreement. 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.
KevinCompounds said:Resolution therefore closed the doors unevenly, and the asymmetry follows from the bulks lists.
This is where I part company with the consensus forming above. 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.
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Browse GL BiochemThis one has a reasonably settled answer, so here it is. They are two different exemptions from the same federal requirements and they buy different things. A 503A pharmacy is regulated primarily by the state board, needs a patient-specific prescription, is exempt from CGMP, and may use a bulk substance that has a USP monograph, is a component of an approved drug, or appears on the 503A bulks list — three independent doorways. A 503B outsourcing facility registers with the FDA, is inspected on a risk basis, must comply with CGMP, may compound for office stock without a patient-specific prescription, and has one doorway to a permitted bulk substance: the 503B bulks list, or the drug shortage list.
pete_manc_UK said:The shortage clause is the answer to the second question and it is a subtraction rather than an addition.
Agreed, and it is worth saying that rounding to the nearest whole unit is usually acceptable at maintenance doses and is not acceptable at the bottom of a ladder, where one unit can be a fifth of the intended dose.