My experience of compounding permissions contradicts the reply above. I am posting it as a data point rather than as a refutation, because one person's experience is exactly that.
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Sourcing · Regulatory · continued
Follow-up: How compounding permissions changed when supply normalised posts 31–60
This is a continuation of a long topic, addressed by post number rather than by page. Start at post 1.
Post #30 put the caveat in the right place and I want to underline 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.
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The arithmetic in post #32 is right; the assumption feeding it is the part to check.
Answering the compounding permissions question as asked, then the question I think is meant. As asked: yes, with the qualification below. As meant: it depends on how the first measurement was taken.
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j.marchetti, post #5: 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. Go to post
Where a claim about legality is made here, the useful follow-up is which instrument it rests on. Most such claims turn out to rest on a forum post.
Thank you for the correction. I would rather find out here than later.
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Post #34 and I disagree about the size of the effect, not about the direction.
On compounding permissions: the maintained page in the documentation commons covers the general case with citations and a review date, which is more reliable than any reply here including this one.
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s.teixeira, post #1: 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… Go to post
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.
The right answer here may simply be that it has not been measured.
m.yildiz, post #9: 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. Go to post
The question underneath compounding permissions is usually "how would I tell?" rather than "what is true?", and that one has a method attached to it.
Write down what you would expect to see under each hypothesis before you collect anything. If they predict the same observation, collecting it will not help.
This follows post #36 rather than contradicting it.
Agreed on compounding permissions, with one qualification that I think matters. The reasoning holds for the case as described. Change the starting assumption and it does not, and the starting assumption is the part nobody states.
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Tavares, post #20: Nothing in this subcategory is legal advice, and the members who work in regulated environments are the most careful to say so. Go to post
A compound in a compounding pathway in one country and unavailable in another is a common situation and produces most of the confusion here.
An update on my earlier compounding permissions post: the pattern held for another six weeks and then stopped, which I did not predict and cannot explain.
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m.adebayo, post #17: Compounding permissions looks different depending on whether you are reading the primary literature or the summaries of it, and the difference is not in our favour. Go to post
Saving this. It is the version I will quote when the question comes round again.
Norrington, post #8: 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. Go to post
An honest declaration on compounding permissions: I have a prior here and it is strong enough that you should weight what I say downward. Stating it rather than hiding it.
Where I part company with post #47, and it is a narrow parting.
Compounding permissions is worth one more sentence than it usually gets, and the sentence is the one about how the number was arrived at.
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Post #47 is the version of this I will quote in future. One addition.
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.
Same conclusion as the reply above, reached differently, which is mildly reassuring.
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forest_plot, post #31: My experience of compounding permissions contradicts the reply above. I am posting it as a data point rather than as a refutation, because one person's experience is exactly that. Go to post
Nobody has said the unglamorous part of compounding permissions yet, so: most of the variation is explained by things that are boring to write about and easy to check.
What I would want before treating compounding permissions as settled: the method, the sample, and whether anyone tried to find the opposite result. Two of the three are usually missing.
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Picking up post #50: that is the part I would want checked first.
An indication approved for one age range does not extend to another, and paediatric extensions are separate decisions with separate evidence.
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I would put moderate confidence on the mainstream reading of compounding permissions and no more. That is not scepticism for its own sake; it is where the sourcing actually stops.
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Nothing in this subcategory is legal advice, and the members who work in regulated environments are the most careful to say so.
I have separated what I observed from what I concluded, which does not always happen.
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n.achebe, post #11: 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. Go to post
Helpful, and easy to find again, which is half of what a good reply is.
p.novotny, post #24: That is the distinction I keep failing to hold on to. Written down now. Go to post
Narrowing post #57, because the general version has more than one answer.
The confident answers on compounding permissions and the well-sourced answers are not the same answers, which is the most useful thing I have learned reading this category.
c.ostergaard, post #38: The question underneath compounding permissions is usually "how would I tell?" rather than "what is true?", and that one has a method attached to it. Write down what you would expect to see under each hypothesis before you collect anything. If they predict the same observation, collecting it will not help. Go to post
Everything in post #56 holds. The case it does not cover is the one I have.
Where I have landed on compounding permissions, having got it wrong once in public: the direction is clear, the magnitude is not, and anyone quoting a precise magnitude has borrowed it from somewhere that did not measure it.