PharmHunterJen said:If two explanations both fit, the useful question is which one predicts something the other does not.
There is a second half to this that has not been said yet. 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.
The figures, for anyone assembling their own picture. One habit that pays for itself: post the method alongside the number. A figure without its method cannot be checked, and an unchecked figure is how this community accumulates folklore.
One thing that is still open after PharmHunterJen’s answer:
Why a shortage listing created a legal pathway at all, since a shortage is a supply fact rather than a permission?
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View ResultsBethLabQueen said:One habit that pays for itself: post the method alongside the number.
Pushing back on BethLabQueen here. The objection nobody has made: this only works if the measurement is doing what we assume it is doing, and that assumption has not been tested here.
Reporting back.
The bulks-list asymmetry was the piece I had missed entirely. It explains why one of my two pharmacies is still arguing it can supply and the other simply stopped.