Follow-up: How compounding permissions changed when supply normalised posts 61–78
This is a continuation of a long topic, addressed by post number rather than by page. Start at post 1.
Post #60 put the caveat in the right place and I want to underline it.
Worth separating compounding permissions as a question about the compound from compounding permissions as a question about the documentation. They get answered by different people and only one of them is answerable here.
Building on post #63 rather than restating it.
Small correction to my own earlier position on compounding permissions. I had the units the wrong way round, which changes the conclusion by an order of magnitude and therefore changes it entirely.
Nothing in this subcategory is legal advice, and the members who work in regulated environments are the most careful to say so.
Where I part company with post #65, and it is a narrow parting.
Two things can be true about compounding permissions at once: the mechanism is plausible and the evidence for the size of the effect is thin. Most of the argument here is people defending the first against attacks on the second.
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.
A qualification I should have led with rather than closed on.
On post #65 — agreed on the reasoning, with one qualification.
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 this at better than even and not much better.
Picking up post #69: that is the part I would want checked first.
Compounding permissions is well covered in the tag pages, and the older discussions are better than the recent ones because they were argued out properly. Worth twenty minutes before adding to this one.
I would call the community position on compounding permissions likely rather than established, and I would be comfortable defending that hedge.
An indication approved for one age range does not extend to another, and paediatric extensions are separate decisions with separate evidence.
A compound in a compounding pathway in one country and unavailable in another is a common situation and produces most of the confusion here.
I would call that likely rather than established.
Narrowing post #72, because the general version has more than one answer.
Since compounding permissions keeps coming up, it should probably be a maintained page rather than a recurring thread. I am happy to draft it if someone with more direct experience will review it.
Helpful, and short, which on this subject is harder than long.
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.
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.
For what it is worth, the same held on the two occasions I checked.
This topic was referenced in
- Import rules for personal quantities, by jurisdiction, datedSourcing › Regulatory · 3 replies
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