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.
Revisiting: Why a compound being unapproved is not the same as being illegal to possess posts 61–83
This is a continuation of a long topic, addressed by post number rather than by page. Start at post 1.
Practical note that does not fit anywhere else. Whatever you conclude from this topic, write down what you did and when. The single most useful thing in your own records is not any individual result; it is that they are dated and consecutive.
This follows post #60 rather than contradicting 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.
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.
Why this category is maintained as documentation, not as recommendations: the goal is factual accuracy and sourcing, not endorsement of any specific regulatory position.
On post #62 — 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.
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 #68 is right about the mechanism and I think understates the practical bit.
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.
Two things before anyone answers the substance.
First, the context in the first post is clear and specific. Second, the question is framed so that an answer can actually address it. Both are the norm here and both matter more than they sound.
Picking up post #69: that is the part I would want checked first.
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.
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.
I read post #73 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.
This follows post #73 rather than contradicting it.
I disagree with the reply above, and I think the disagreement is substantive rather than terminological.
The distinction being drawn does not survive when you look at the published data for this specific question. I would be glad to be shown wrong on this, because the version I am arguing against is more convenient.
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.
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.
This follows post #78 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.
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.
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.
This topic was referenced in
- Reading a regulatory notice rather than an article about itSourcing › Regulatory · 2 replies
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