HPLC_Greg 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.
If somebody has the primary source to hand I would rather cite it than paraphrase it.