My pharmacy stopped supplying with three weeks notice and a letter that explained nothing, so I went and read the statute.
What I am trying to establish is why a shortage listing created a legal pathway at all, since a shortage is a supply fact rather than a permission.
Practical detail welcome, however dull — the duller the better.
This one has a reasonably settled answer, so here it is. They are two different exemptions from the same federal requirements and they buy different things. A 503A pharmacy is regulated primarily by the state board, needs a patient-specific prescription, is exempt from CGMP, and may use a bulk substance that has a USP monograph, is a component of an approved drug, or appears on the 503A bulks list — three independent doorways. A 503B outsourcing facility registers with the FDA, is inspected on a risk basis, must comply with CGMP, may compound for office stock without a patient-specific prescription, and has one doorway to a permitted bulk substance: the 503B bulks list, or the drug shortage list.
That is the short version; the long version is somebody else's post.
Dr.SurgeonPGH said:They are two different exemptions from the same federal requirements and they buy different things.
Agreeing with Dr.SurgeonPGH, and the qualification matters more than the agreement. Worth adding the genuine exception, because it is real and narrow: a change made for an identified patient where the prescriber determines it produces a significant clinical difference for that patient. A grid of fixed doses offered to everybody is not that, whatever the intake form says.
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Shop Reference StandardsZaraB_AL 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 ZaraB_AL describes. 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.
Ask again with the specifics and you will get a better answer than this one.
From the other side of the consultation, briefly.
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 shortage ongoing, tirzepatide partially resolved. This directly impacts compounding availability.