amsterdam_pete said:

The variables that decide how a cross-border order goes are declaration wording, the destination country's import rules for prescription medicines,…

amsterdam_pete has the substance of this right. The condition it depends on is worth stating. Worth adding the genuine exception, because it is real and narrow: a change made for an identified patient where the prescriber determines it produces a significant clinical difference for that patient. A grid of fixed doses offered to everybody is not that, whatever the intake form says.

amsterdam_pete said:

The variables that decide how a cross-border order goes are declaration wording, the destination country's import rules for prescription medicines,…

Filing a mild objection. Mild because I might be wrong; an objection because nobody has addressed the case that does not fit. Import rules are jurisdiction-specific and this board keeps giving US-shaped answers to non-US questions. What is a personal-import allowance in one country is a controlled-import offence in another.

I would rather be corrected than agreed with, if it comes to it.

This one has a reasonably settled answer, so here it is. 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.

DebRD_ATL said:

Worth adding the genuine exception, because it is real and narrow: a change made for an identified patient where the prescriber determines it produces…

Same experience, arrived at from the opposite direction. The detail I would add is minor and it is already implied above.