US compounding rules and how they changed posts 31–60
This is a continuation of a long topic, addressed by post number rather than by page. Start at post 1.
Pharmacy practice varies between pharmacies within the same city, so two honest accounts can be entirely different.
That has held every time I have looked, which is not the same as always.
The arithmetic in post #30 is right; the assumption feeding it is the part to check.
Anyone reporting an outcome should give the stated reason rather than the verdict. The reason is the part somebody else can use.
Where a compounding pathway existed and closed, posts describing it stay in the archive and should be read with their date attached.
Post #32 put the caveat in the right place and I want to underline it.
Where a manufacturer runs a direct supply route, that is a commercial arrangement rather than a regulatory change, and it can end.
That is the version I use. It may not be the version that is correct.
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.
Anyone who has looked at this more carefully, please correct the record.
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.
This is the first time the answer has come with its own limits attached. Appreciated.
Everything in post #41 holds. The case it does not cover is the one I have.
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.
Private insurance gaps: some people have private insurance but medication is not covered. Manufacturer assistance programmes are the main resource for cost reduction.
Happy to be the one who is wrong here if it settles the question.
Post #41 and I disagree about the size of the effect, not about the direction.
Shortage status determines what compounding is permitted in some jurisdictions, which is why the availability question and the compounding question are linked.
Taking post #45 at face value and following it one step further.
Prior authorisation criteria are usually published by the payer and reading them before the appointment changes the outcome more than anything else does.
Date every claim in this subcategory. Positions here have moved repeatedly and old posts are read as current.
I am aware this is the third time this month I have made this point.
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.
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.
The strength of my opinion here exceeds the strength of my evidence.
The arithmetic in post #52 is right; the assumption feeding it is the part to check.
Pharmacy practice varies between pharmacies within the same city, so two honest accounts can be entirely different.
The number is defensible. The precision I gave it is not.
Answering the question post #50 raises rather than the one it answers.
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.
Flagging that the sources on this are thinner than the confidence in the thread suggests.
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.
Compounded preparations and authorised products are different regulatory categories with different oversight, and conflating them produces most of the confusion here.
Cross-border purchasing raises both a legal question and a practical one, and the legal one is yours to establish for your own jurisdiction.
Caveat: everything above assumes the paperwork is what it says it is.
Everything in post #54 holds. The case it does not cover is the one I have.
Anyone reporting an outcome should give the stated reason rather than the verdict. The reason is the part somebody else can use.
I am confident about the direction and much less about the magnitude.
This follows post #56 rather than contradicting it.
Appeals succeed more often than people expect when they answer the stated criterion point by point and include nothing else.
The conclusion is tentative; the arithmetic underneath it is not.
Thank you for taking the time. That was more work than a reply usually is.