KevinCompounds said:The bulks-list asymmetry was the piece I had missed entirely.
Same pattern here, and in the same order. Posting only so the count is not one.
KevinCompounds said:The bulks-list asymmetry was the piece I had missed entirely.
Coming at KevinCompounds’s question from a different direction. 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.
Correct me if the detail matters more than I have assumed.
Adding the numbers, since they settle part of this. Say what you would expect to see if you were wrong, before you look. It is a small discipline and it changes what you notice.
Worth separating that from compounded supply, which this thread keeps folding into the same question. They behave differently and the advice does not transfer.
Ask again with the specifics and you will get a better answer than this one.
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Browse GL BiochemFollowing on from KevinCompounds — and this may be the naive question:
Why a shortage listing created a legal pathway at all, since a shortage is a supply fact rather than a permission?
Dr.PeteFamMed said:Say what you would expect to see if you were wrong, before you look.
Worth saying that the confident version of this is more useful to the person writing it than to the person reading it.