This is a continuation of a long topic, addressed by post number rather than by page. Start at post 1.
Coming back to post #119, because the follow-up matters more than the original answer.
Where I would push back on the Research-use-only labelling consensus is the confidence, not the direction. The direction looks right. The confidence is borrowed.
I would keep Research-use-only labelling and the decision it usually gets used for separate in this thread. They are related and they are not the same question, and merging them is why the last one went badly.
Off-label use and medical practice: clinicians can prescribe approved medications off-label under some circumstances. That is different from research-use-only compounds, which are not approved for any human use.
That is what I would do. It may not be what is correct.
Adding a note of thanks rather than an opinion. I did not know most of that.
I read post #123 twice before replying, because I had assumed the opposite.
Nothing in this subcategory is legal advice, and the members who work in regulated environments are the most careful to say so.
Post #123 answers the question as asked. The question underneath it is different.
Having read the whole Research-use-only labelling thread before replying: the question in the first post has not actually been answered yet, and three of us have answered a nearby one instead.
An indication approved for one age range does not extend to another, and paediatric extensions are separate decisions with separate evidence.
That matches what I was told, which is not the same as knowing it.
The practical version of Research-use-only labelling is three sentences long. The rigorous version is three pages and reaches the same conclusion with the conditions attached.
Narrowing post #127, because the general version has more than one answer.
Research-use-only material is not approved for human use anywhere. That is a statement about the material's regulatory category rather than about its quality.
Building on post #130 rather than restating it.
Adding the boring version of Research-use-only labelling, because the interesting version keeps getting posted and the boring one is usually right.
Check the ordinary explanations, in order, and stop when one of them accounts for what you are seeing. Most of the time the second one does.
Post #128 put the caveat in the right place and I want to underline it.
The confident answers on Research-use-only labelling and the well-sourced answers are not the same answers, which is the most useful thing I have learned reading this category.
Generic or biosimilar entry depends on patent and exclusivity positions that are jurisdiction-specific and are frequently misreported.
Scoping that to what I have actually seen rather than what I have read.
That is a cleaner way of putting what I was circling around.
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.
Happy to expand any of that if it is the useful part.
Research-use-only labelling is one of those subjects where the general answer and the answer for a specific case diverge, and the thread will go in circles until someone says which one is being asked for.
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.
It is worth stating the boring hypothesis before the interesting one.
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 be interested in a counterexample if anyone has one.
Research-use-only labelling is worth one more sentence than it usually gets, and the sentence is the one about how the number was arrived at.
Post #141 describes the usual case. This is about the unusual one.
The reason Research-use-only labelling keeps being re-asked is that the answer is conditional and people quote it without the condition. It is not that the answer is unknown.
Adding the measurement that post #141 says would settle it.
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.
I would call that likely rather than established.
The arithmetic in post #146 is right; the assumption feeding it is the part to check.
My experience of Research-use-only labelling 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.
I read post #146 twice before replying, because I had assumed the opposite.
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.
Post #149 answers the question as asked. The question underneath it is different.
On Research-use-only labelling: 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.