International compounding regulations — anyone have experience?

Dr.RenalNash said:

They are two different exemptions from the same federal requirements and they buy different things.

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.

One concrete data point for the thread. Two things anyone can check: a state licence number for a 503A, and an FDA outsourcing-facility registration for a 503B. Both are publicly searchable, and a pharmacy unwilling to give you either has answered the question.

sarah.morrison said:

Import rules are jurisdiction-specific and this board keeps giving US-shaped answers to non-US questions.

Coming at sarah.morrison’s question from a different direction. 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.

Following on from TomFromTexas — and this may be the naive question:

Why a shortage listing created a legal pathway at all, since a shortage is a supply fact rather than a permission?

Reporting back.

The bulks-list asymmetry was the piece I had missed entirely. It explains why one of my two pharmacies is still arguing it can supply and the other simply stopped.