TrialNerd_Beth said:The shortage clause is the answer to the second question and it is a subtraction rather than an addition.
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.
MariaRD said:Agreed on the mechanism, with the caveat that the head-to-head used semaglutide 1mg, not 2.4mg.
Thank you for spelling out the reasoning rather than just the conclusion. I will report back once I have actually tried it.
TrialNerd_Beth 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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Browse GL BiochemOne concrete data point for the thread. Say what you would expect to see if you were wrong, before you look. It is a small discipline and it changes what you notice.