My pharmacy stopped supplying with three weeks notice and a letter that explained nothing, so I went and read the statute.
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 am after is why a shortage listing created a legal pathway at all, since a shortage is a supply fact rather than a permission. Tell me what I have not thought of.
PharmHunterJen said:My pharmacy stopped supplying with three weeks notice and a letter that explained nothing, so I went and read the statute.
PharmHunterJen has the substance of this right. The condition it depends on is worth stating. 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.
If somebody has the primary source to hand I would rather cite it than paraphrase it.
PharmHunterJen said:My pharmacy stopped supplying with three weeks notice and a letter that explained nothing, so I went and read the statute.
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.
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Browse GL BiochemThis one has a reasonably settled answer, so here it is. 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.
CarlaRPh_TPA said:Resolution therefore closed the doors unevenly, and the asymmetry follows from the bulks lists.
This is my experience too, for whatever a second data point is worth.