Putting this up for argument rather than for agreement. I have read it twice and I am still not certain what it supports.
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.
Where I think it is weakest: the follow-up is short relative to how long people actually take these drugs, so durability is an assumption here rather than a finding.
What I am trying to establish is what actually distinguishes 503A from 503B, in terms of what each may make and from what starting material. 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.
JakeBK_lifts said:Resolution therefore closed the doors unevenly, and the asymmetry follows from the bulks lists.
No disagreement with JakeBK_lifts. One condition attached. 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.
JakeBK_lifts said:Resolution therefore closed the doors unevenly, and the asymmetry follows from the bulks lists.
I read this differently from JakeBK_lifts, 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.
I would rather be corrected than agreed with, if it comes to it.
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View ResultsThis 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.
PharmacoVig_BOS said:The shortage clause is the answer to the second question and it is a subtraction rather than an addition.
Can confirm. Same sequence, different timescale.