This is the version of the explanation I wish somebody had given me, written down before I forget what confused me. It is about cross-border ordering, and it is deliberately narrow — everything I am not confident about is marked as such.
What is actually established
The variables that decide how a cross-border order goes are declaration wording, the destination country's import rules for prescription medicines, and whether the shipment looks commercial. Personal-import allowances exist in some jurisdictions and not in others, and where they exist they are usually conditional on a prescription and a quantity limit. The failure mode is normally a seizure notice rather than anything worse, and a reshipment policy is the thing worth confirming before ordering rather than after.
The condition it depends on
Cold chain is the underrated risk on long routes. A shipment held at a border for a week has had a temperature excursion whether or not it arrives.
What I am not sure about
What I am after is which of the variables in a cross-border order actually determine the outcome, and which are superstition. Practical detail welcome, however dull — the duller the better.
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.
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Shop Reference StandardsThis 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.