International compounding regulations — looking for input

SandraNC_45 said:

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

That is correct as far as it goes, and here is where it stops going. 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.

SandraNC_45 said:

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

Pushing back on SandraNC_45 here. 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. They are two different exemptions from the same federal requirements and they buy different things. A 503A pharmacy is regulated primarily by the state board, needs a patient-specific prescription, is exempt from CGMP, and may use a bulk substance that has a USP monograph, is a component of an approved drug, or appears on the 503A bulks list — three independent doorways. A 503B outsourcing facility registers with the FDA, is inspected on a risk basis, must comply with CGMP, may compound for office stock without a patient-specific prescription, and has one doorway to a permitted bulk substance: the 503B bulks list, or the drug shortage list.

Dr.ObesityLA 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…

Mine went the same way, slower.