Thank you for the correction. I have edited my earlier post with a note rather than silently, so the thread still makes sense to read. The error was mine and it was the kind that comes from remembering a figure instead of looking it up.
Pharmaceutical compounding rules, summarised from primary sources posts 31–60
This is a continuation of a long topic, addressed by post number rather than by page. Start at post 1.
On post #28 — agreed on the reasoning, with one qualification.
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.
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.
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.
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.
This follows post #34 rather than contradicting it.
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.
Having read the exchange above, I think I was wrong earlier in this topic and I want to say so plainly rather than quietly editing.
The correction was fair and I had been repeating something I had not checked carefully enough.
post #38 answers the question as asked. The question underneath it is different.
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.
On post #37 — agreed on the reasoning, with one qualification.
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.
post #41 answers the question as asked. The question underneath it is different.
Thank you for the correction. I have edited my earlier post with a note rather than silently, so the thread still makes sense to read. The error was mine and it was the kind that comes from remembering a figure instead of looking it up.
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.
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.
post #45 is right about the mechanism and I think understates the practical bit.
Why this category is maintained as documentation, not as recommendations: the goal is factual accuracy and sourcing, not endorsement of any specific regulatory position.
I read post #45 twice before replying, because I had assumed the opposite.
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.
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.
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.
Collapsed as off-topic by two members at trust level 3 or above
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.
On post #50 — agreed on the reasoning, with one qualification.
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.
Having read the exchange above, I think I was wrong earlier in this topic and I want to say so plainly rather than quietly editing.
The correction was fair and I had been repeating something I had not checked carefully enough.
post #56 is right about the mechanism and I think understates the practical bit.
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.
Worth separating two things that post #54 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.
Primary documents matter: regulatory positions are published in official documents. Reading the regulatory agency's website directly is more reliable than reading a forum summary of it.
Coming back to post #58, because the follow-up matters more than the original answer.
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.