My compounded sema journey — 12 months, 6 pharmacies, lessons learned

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.

This 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.