This is a continuation of a long topic, addressed by post number rather than by page. Start at post 1.
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.
Worth saying I have only my own numbers here, and n is small.
Picking up post #32: that is the part I would want checked first.
Nothing in this subcategory is legal advice, and the members who work in regulated environments are the most careful to say so.
On post #30 — agreed on the reasoning, with one qualification.
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.
The bit of compound being unapproved that nobody enjoys is that the answer changes depending on what you are trying to decide with it. Say what the decision is and the thread will converge.
Adding the measurement that post #36 says would settle it.
Preclinical versus clinical: compounds with strong preclinical data can fail in clinical trials. Compounds with no human data are being used on theoretical grounds. The regulatory position reflects this asymmetry.
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 would want the raw data before agreeing with my own summary of it.
Post #36 answers the question as asked. The question underneath it is different.
Where the compound being unapproved discussion usually stalls is that nobody wants to say "I do not know" and everyone is willing to say "it varies". Those are the same sentence with different clothes on.
If you are new and reading this thread for the answer to compound being unapproved: the answer is conditional, the conditions are in the third reply, and the rest of the thread is worth skipping.
Everything in post #39 holds. The case it does not cover is the one I have.
A compound in a compounding pathway in one country and unavailable in another is a common situation and produces most of the confusion here.
Worth one more sentence than it usually gets.
Bookmarking this. I will come back when I have something worth adding.
A note on scope: what I am saying about compound being unapproved applies to the case in the first post and I would not extend it further without checking.
The arithmetic in post #43 is right; the assumption feeding it is the part to check.
An indication approved for one age range does not extend to another, and paediatric extensions are separate decisions with separate evidence.
Not the answer, but possibly the question that gets there.
Adding a null result on compound being unapproved. I looked, carefully, and found nothing, and null results deserve posting precisely because they never are.
Same experience here, different supplier, so it is at least not unique to one of them.
Generic or biosimilar entry depends on patent and exclusivity positions that are jurisdiction-specific and are frequently misreported.
Somebody will have a better source than mine, and I hope they post it.
Post #50 is the version of this I will quote in future. One addition.
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.
Posted with less confidence than the sentence structure implies.
No disagreement from me. Posting only so the question does not look ignored.
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.
Practical answer on compound being unapproved, since the theoretical one is upthread: do the simplest check first, write down the result, and only then decide whether the complicated explanation is needed. It usually is not.
Post #53 put the caveat in the right place and I want to underline it.
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.
I would put this at better than even and not much better.
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 uncertainty is in the assumption, not in the calculation.
Nothing in this subcategory is legal advice, and the members who work in regulated environments are the most careful to say so.
One more thing on compound being unapproved that took me far too long to see: the two figures people quote are not measuring the same quantity. Once you notice that, the apparent contradiction disappears.