On the subject in the title: Revisiting: Why a compound being unapproved is not the same as being illegal to possess Working notes rather than a conclusion.
I would like to know what people here actually do about compound being unapproved, as distinct from what is usually recommended. Those have diverged in every other subject I have looked at closely.
Mine is below, with the reasoning, including the parts I am not confident about.
Small methodological point on compound being unapproved: repeating a measurement is cheap and resolves most of what is being argued about here at no cost to anyone.
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.
This has been discussed before and I could not find the thread, so, again.
Careful with the language on compound being unapproved. "Not detected" and "not present" are different findings and the first is a statement about the method.
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.
Picking up post #6: that is the part I would want checked first.
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.
Posting it because the silence on this was starting to look like agreement.
Narrowing post #6, because the general version has more than one answer.
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.
Adding a source would improve this post and I do not have one to hand.
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.
Not the answer, but possibly the question that gets there.
Building on post #11 rather than restating it.
One caution on compound being unapproved: everything above assumes the underlying documentation is what it claims to be. That assumption is doing real work and is rarely stated.
Everything in post #11 holds. The case it does not cover is the one I have.
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.
Two people can read the same figure differently here and both be reasonable.
Post #11 and I disagree about the size of the effect, not about the direction.
On compound being unapproved, I would rather understate and be corrected upward than overstate and be quoted. That is a house style here and it is a good one.
Taking post #15 at face value and following it one step further.
A compound in a compounding pathway in one country and unavailable in another is a common situation and produces most of the confusion here.
Noting that the question and the thing people usually mean by it are different.
This settles it for me, at least until somebody posts a reason it should not.
Post #15 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.
Not a strong opinion, just a consistent one.
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.
If anyone has run this properly I would rather read that than my own guess.
The reason compound being unapproved 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.
Post #20 answers the question as asked. The question underneath it is different.
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.
Stating my assumptions rather than smuggling them in.
I read post #22 twice before replying, because I had assumed the opposite.
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.
The right answer here may simply be that it has not been measured.
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.
Take it as a starting point and not as a specification.
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.
One more caveat and then I will stop qualifying: the sample selected itself.
Everything in post #26 holds. The case it does not cover is the one I have.
If someone has run compound being unapproved properly I would rather read that than my own reconstruction of it. Posting mine only because the thread has gone quiet.
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 am describing what is, rather than arguing for what should be.
Where I part company with post #26, and it is a narrow parting.
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.