International compounding regulations — US vs EU vs AU comparison

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.

Answering the narrow version, because the broad one does not have a single answer. Resolution therefore closed the doors unevenly, and the asymmetry follows from the bulks lists. For 503B the shortage clause was the only route to these molecules, so that route shut completely. A 503A pharmacy can still argue a doorway via "component of an approved drug" — but only for the substance in the form present in the approved product, which is exactly where the base-versus-salt argument lives, and it does nothing about the copy restriction, which came back into force on resolution.

labquiet_amy 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…

This matches mine closely enough to be worth saying so out loud. Nothing to add that would improve it.