US compounding rules and how they changed — setting out what I have, and where I think it stops being reliable.
Reporting a regional experience with the date and the jurisdiction attached, because an undated regional account is the least useful thing in this category.
What happened, in order, with the stated reason at each step. The stated reason is the part that generalises; the outcome is not.
Picking up the opening post: that is the part I would want checked first.
Compounding pharmacies: pharmaceutical compounding of a drug not on the FDA shortage list is substantially constrained. The landscape changed when supply normalised. Current compounding availability is limited.
Pharmacy practice varies between pharmacies within the same city, so two honest accounts can be entirely different.
I keep a log of this specifically because memory is unreliable about it.
This follows post #3 rather than contradicting it.
Say which country and which state or province. Regulatory position, availability and practical route can all differ within the same continent and frequently do.
That is a fair summary of where the discussion has got to.
Compounded preparations and authorised products are different regulatory categories with different oversight, and conflating them produces most of the confusion here.
Someone should write this up properly, and it should probably not be me.
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.
I am reporting what happened, not recommending it.
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.
Both are useful and different. The account tells you what happens in practice; the criterion tells you what to write.
It cost nothing to check and would have cost something not to.
Post #12 answers the question as asked. The question underneath it is different.
Date every claim in this subcategory. Positions here have moved repeatedly and old posts are read as current.
Where a manufacturer runs a direct supply route, that is a commercial arrangement rather than a regulatory change, and it can end.
Shortage status determines what compounding is permitted in some jurisdictions, which is why the availability question and the compounding question are linked.
I would want to see it done twice before believing it once.
The public assessment documents published at approval are free, detailed and largely unread here.
A partial answer, offered because a partial answer beats none.
That matches what I have seen, for whatever a single anecdote is worth.
Worth separating two things that post #19 runs together.
Cost comparisons should state whether they include the device and the dispensing fee, because those differ between routes and between states.
This follows post #23 rather than contradicting it.
The denial letter is the specification for the appeal. It states a criterion and the job is to demonstrate that criterion in the letter's own language.
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.
Post #23 and I disagree about the size of the effect, not about the direction.
Cost comparisons should state whether they include the device and the dispensing fee, because those differ between routes and between states.
Cross-border purchasing raises both a legal question and a practical one, and the legal one is yours to establish for your own jurisdiction.
For what it is worth, the same held on the two occasions I checked.
Post #27 is the version of this I will quote in future. One addition.
Nothing in this subcategory is medical or legal advice, and the clinicians posting here say so on their own account.