My pharmacy stopped supplying with three weeks notice and a letter that explained nothing, so I went and read the statute.
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 narrow version of the question is what actually distinguishes 503A from 503B, in terms of what each may make and from what starting material.
Happy to be told the question itself is wrong.
This one has a reasonably settled answer, so here it is. 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.
Correct me if the detail matters more than I have assumed.
JessicaH_TX said:Resolution therefore closed the doors unevenly, and the asymmetry follows from the bulks lists.
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.
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Shop Reference StandardsCryptoCarl said:My pharmacy stopped supplying with three weeks notice and a letter that explained nothing, so I went and read the statute.
Can confirm the pattern CryptoCarl describes. 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.
Happy to go further on any of that.
Clinical perspective, offered as context rather than as advice.
Regarding compounded supply compounding legality: compounding pharmacies can legally produce semaglutide and tirzepatide while these drugs remain on the FDA shortage list. If/when the shortage resolves, the legal landscape may change.
Stay informed. The FDA shortage list is updated regularly. Current status as of my last check: semaglutide partially resolved shortage, tirzepatide still in shortage. This directly impacts compounding availability.