How compounding permissions changed when supply normalised I have a specific reason for asking rather than idle curiosity, and the context is below.
I was wrong about compounding permissions in a thread last spring and I would like to correct it publicly rather than quietly.
The error was in the units, which changed the conclusion by an order of magnitude. Setting out the corrected version, and the way I now check for that class of mistake.
Two claims get bundled together under compounding permissions and they need separating. The descriptive one — this is what was observed — is usually well supported. The causal one — this is why — usually is not.
Almost every disagreement in threads like this one dissolves once you say which of the two you are making.
Good question, well framed, and I would like to see it answered properly.
The opening post answers the question as asked. The question underneath it is different.
Compounding and pharmacy rules: some jurisdictions allow a pharmacy to compound a drug that is not on the market under specific conditions. The conditions are strict and vary by jurisdiction. Generalising from one country's rules to another's is unreliable.
I would put the burden of proof on the interesting explanation, not the dull one.
Worth separating two things that the opening post runs together.
An indication approved for one age range does not extend to another, and paediatric extensions are separate decisions with separate evidence.
That is one dataset and I would not build a rule on it.
Speaking only to compounding permissions as I have actually seen it, rather than as it is usually described: the effect is real, it is smaller than the thread suggests, and the variance between people is larger than the effect.
I disagree with the framing of compounding permissions above, and I think it is a substantive disagreement rather than a terminological one. Setting out why, so it can be checked.
The reasoning depends on an assumption that is doing a lot of work and is never stated. If the assumption holds, the conclusion follows. I do not think it holds generally.
Post #5 is right about the mechanism and I think understates the practical bit.
Generic or biosimilar entry depends on patent and exclusivity positions that are jurisdiction-specific and are frequently misreported.
Worth reading the earlier posts in this thread before acting on mine.
Post #5 put the caveat in the right place and I want to underline it.
A compound in a compounding pathway in one country and unavailable in another is a common situation and produces most of the confusion here.
It is the kind of thing that is obvious once and never again.
Building on post #9 rather than restating it.
If you can confirm or contradict a position for your own region, please date the answer. An undated regional claim is the least useful thing in this category.
I would put a moderate confidence on that and no more.
Compounding permissions: I have looked for the primary source twice and failed twice. Either it does not exist or it is somewhere I do not know to look, and I would like to know which.
Where I part company with post #8, and it is a narrow parting.
Careful with the language on compounding permissions. "Not detected" and "not present" are different findings and the first is a statement about the method.
Confirming post #14 from a second method, which matters more than confirming it from a second person.
The practical version of compounding permissions is three sentences long. The rigorous version is three pages and reaches the same conclusion with the conditions attached.
I had written a reply contradicting post #12 and deleted it. Here is what survived.
Compounding and pharmacy rules: some jurisdictions allow a pharmacy to compound a drug that is not on the market under specific conditions. The conditions are strict and vary by jurisdiction. Generalising from one country's rules to another's is unreliable.
If it helps: the failure mode here is usually boring rather than dramatic.
Small methodological point on compounding permissions: repeating a measurement is cheap and resolves most of what is being argued about here at no cost to anyone.
Generic or biosimilar entry depends on patent and exclusivity positions that are jurisdiction-specific and are frequently misreported.
On reflection I would soften that slightly.
I had written a reply contradicting post #17 and deleted it. Here is what survived.
The strongest argument against my own position on compounding permissions, stated as well as I can state it, since nobody else has yet.
Distinguishing three things in the compounding permissions discussion that keep getting used interchangeably: the observation, the proposed mechanism, and the recommendation that gets attached to both.
Where I part company with post #21, and it is a narrow parting.
I think the compounding permissions question is answerable and has not been answered, which is a more optimistic position than most of this thread.
Post #25 is the version of this I will quote in future. One addition.
A compound in a compounding pathway in one country and unavailable in another is a common situation and produces most of the confusion here.
That is the honest state of it as of this week.
Where the compounding permissions reasoning breaks down for me is the step from the group result to the individual case. That step is almost never argued for.
Building on post #29 rather than restating it.
Where I would push back on the compounding permissions consensus is the confidence, not the direction. The direction looks right. The confidence is borrowed.