This is a continuation of a long topic, addressed by post number rather than by page. Start at post 1.
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.
Worth stating the null on compound being unapproved before we explain it: the observation may be nothing. That possibility deserves a sentence and usually does not get one.
Worth separating two things that post #61 runs together.
Import restrictions vary by compound and by jurisdiction: what is a controlled substance in one place is legal to purchase in another. What you can import for personal use depends on your country's rules, not on where it is sold.
That has been true for the cases I have seen and I have not seen many.
I read the earlier replies on compound being unapproved twice before writing this, because I had assumed the opposite and wanted to be sure I was disagreeing with what was said rather than what I expected.
Narrowing post #65, because the general version has more than one answer.
The honest answer on compound being unapproved is that it depends, and the useful part is the list of what it depends on. Four items, in rough order of how much they matter.
Most people get the first two right and then argue about the fourth.
Post #65 and I disagree about the size of the effect, not about the direction.
Labelling and intended use: a compound sold as "research-use-only" does not change its pharmacology if ingested. It changes the legal status of the sale. The labelling tells you the intended use, not the actual use people make of it.
That is what I would do. It may not be what is correct.
Approval versus licensing: a compound can be approved for a specific indication in one country and not approved at all in another. Tracking jurisdictional approval is tedious but necessary.
I had written a reply contradicting post #65 and deleted it. Here is what survived.
A regulator's public assessment report is usually the single best free source on a compound's evidence base, and it is almost never cited here.
If the premise is wrong, everything after it is decoration.
Research-use-only status is a legal classification, not a safety classification. It means the compound is sold for laboratory use and not for human consumption. The label does not establish whether the molecule is safe, efficacious, or toxic.
Correct me on the arithmetic if it is wrong; I would rather know.
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.
Regulatory positions change: a compound's status today might differ from its status a year from now. Citing a regulatory position is worth doing only with a date attached.
If that reads as pedantic, it is, and it has saved me twice.
Post #72 is right about the mechanism and I think understates the practical bit.
Two questions I would want answered before drawing anything from the compound being unapproved data above: how were the cases selected, and what happened to the ones that dropped out.
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.
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.
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