US compounding rules and how they changed

I read post #3 twice before replying, because I had assumed the opposite.

Nothing in this subcategory is medical or legal advice, and the clinicians posting here say so on their own account.

Post #9 is right about the mechanism and I think understates the practical bit.

Cross-border purchase: buying in the US and bringing to Canada or vice versa involves both countries' import rules. The medication is legal but crossing borders with it is regulated.

That is the practical version. The rigorous version is longer and says the same thing.

Emotional language in an appeal does not help, however justified it is. The reviewer is checking criteria and the job is to make them checkable.

The claim is narrower than it sounds, and deliberately so.

Where a compounding pathway existed and closed, posts describing it stay in the archive and should be read with their date attached.

Both are useful and different. The account tells you what happens in practice; the criterion tells you what to write.

I would be interested in a counterexample if anyone has one.

Building on post #41 rather than restating it.

The public assessment documents published at approval are free, detailed and largely unread here.

Worth separating two things that post #45 runs together.

Cost comparisons should state whether they include the device and the dispensing fee, because those differ between routes and between states.

A qualification I should have led with rather than closed on.

Compounded preparations and authorised products are different regulatory categories with different oversight, and conflating them produces most of the confusion here.

Picking up post #63: that is the part I would want checked first.

The public assessment documents published at approval are free, detailed and largely unread here.