The figures, for anyone assembling their own picture. 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.
Following on from Dr.KarenChen — 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?
dave_SLC said:Two things anyone can check: a state licence number for a 503A, and an FDA outsourcing-facility registration for a 503B.
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.
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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.
SarahChen_PharmD said:The shortage clause is the answer to the second question and it is a subtraction rather than an addition.
Agreed, and 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.