pat_auckland said:They are two different exemptions from the same federal requirements and they buy different things.
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.
tommy_boulder said:Agreed on the mechanism, with the caveat that the head-to-head used semaglutide 1mg, not 2.4mg.
That reframing is the part I needed.
pat_auckland said:They are two different exemptions from the same federal requirements and they buy different things.
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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Moderator note: good thread. Keeping it here rather than moving it, because the question is general enough to be useful. No action needed from anybody.