Pharmaceutical compounding rules, summarised from primary sources posts 61–90
This is a continuation of a long topic, addressed by post number rather than by page. Start at post 1.
Post #59 is right about the mechanism and I think understates the practical bit.
Marking my uncertainty on pharmaceutical compounding rules explicitly. I am confident about the direction, much less confident about the size, and not confident at all that it generalises past the case in the first post.
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.
Not a strong opinion, just a consistent one.
Pharmaceutical compounding rules is well covered in the tag pages, and the older discussions are better than the recent ones because they were argued out properly. Worth twenty minutes before adding to this one.
I read post #63 twice before replying, because I had assumed the opposite.
I have no financial interest in anything named in this thread and I want to say so before I comment on pharmaceutical compounding rules, because it is the sort of subject where it matters.
Collapsed as off-topic by two members at trust level 3 or above
Taking post #67 at face value and following it one step further.
A methods point on pharmaceutical compounding rules rather than a substantive one: if the comparison is not like for like, the difference you are measuring is the difference in method.
Post #70 is the version of this I will quote in future. One addition.
Something worth flagging about pharmaceutical compounding rules: the strongest-sounding claims in this thread are the ones with no source attached, which is the usual pattern and not a coincidence.
Where I part company with post #69, and it is a narrow parting.
An indication approved for one age range does not extend to another, and paediatric extensions are separate decisions with separate evidence.
Sensible. I would want the same detail before I acted on it either.
Contradicting a claim in this subcategory is most useful when it comes with a link to the primary source and a date of access.
Small point, but it is the one that usually catches people.
Building on post #74 rather than restating it.
Adding what did not work for me on pharmaceutical compounding rules, since the failures never get written up and they are half the useful information.
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.
Written from notes rather than memory, which is why the numbers are specific.
Everything in post #77 holds. The case it does not cover is the one I have.
Pharmaceutical compounding rules: I would want to see the raw numbers rather than the summary before agreeing. Summaries lose exactly the information that would settle this.
Post-authorisation safety commitments are public and are one of the more useful sources for what a regulator considered uncertain at approval.
That has been true for the cases I have seen and I have not seen many.
Generic or biosimilar entry depends on patent and exclusivity positions that are jurisdiction-specific and are frequently misreported.
I have changed my mind on this once already, so take it as current rather than settled.
Contradicting a claim in this subcategory is most useful when it comes with a link to the primary source and a date of access.
That is the version I would defend. It is not the version I started with.
Post #81 answers the question as asked. The question underneath it is different.
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.
I have deliberately not rounded that, because the rounding is where the argument starts.
Nothing to add on the substance. Thank you for taking the question at face value.
Coming back to post #85, because the follow-up matters more than the original answer.
Import rules for personal quantities differ from commercial import rules and both differ by country. Establishing your own position is not something a forum can do for you.
Adding this to the thread rather than to the wiki, because I am not confident enough for the wiki.
Post #85 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.
I would put this at better than even and not much better.
Where I part company with post #85, and it is a narrow parting.
Read the primary regulatory document rather than a summary of it. Summaries in this area lag by a year routinely and by longer occasionally.
Old habit: I write down the expected answer before I calculate it.
Post #89 is the version of this I will quote in future. One addition.
Nothing in this subcategory is legal advice, and the members who work in regulated environments are the most careful to say so.
I have said this before in a thread nobody could find, so it is worth repeating.