Putting this up for argument rather than for agreement. I have read it twice and I am still not certain what it supports.
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.
Where I think it is weakest: the subgroup findings are the part I trust least — with enough subgroups something is always significant, and these were not all pre-registered.
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.
Figures above are from the primary publication rather than the press summary. If a number here disagrees with one you have, post yours and we will work out which of us is reading a secondary source.
SleepFixSam said:The shortage clause is the answer to the second question and it is a subtraction rather than an addition.
Agreeing with SleepFixSam, and the qualification matters more than the agreement. 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.
I would rather be corrected than agreed with, if it comes to it.
SleepFixSam said:The shortage clause is the answer to the second question and it is a subtraction rather than an addition.
Filing a mild objection. Mild because I might be wrong; an objection because nobody has addressed the case that does not fit. 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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Shop Reference StandardsThis 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.
mike_nyc said:They are two different exemptions from the same federal requirements and they buy different things.
This is my experience too, for whatever a second data point is worth. Nothing to add that would improve it.