What a regulator's shortage notice actually authorises — what changed since

The question in the title: What a regulator's shortage notice actually authorises — what changed since I will give what I have already checked below so nobody repeats it.

A logistics question, since the answers here are usually better than anywhere else I have looked.

Parcel despatched 7 days ago, tracking last updated 3 days ago at a customs facility, no further movement. Cold pack included at despatch.

Two questions. First, at what point is this genuinely a problem rather than an ordinary delay? Second, if it does arrive, what is the actual decision process for assessing it, as opposed to the two extremes people usually offer?

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.

On the opening post — agreed on the reasoning, with one qualification.

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.

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.

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.

post #7 is right about the mechanism and I think understates the practical bit.

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.

Coming back to post #7, because the follow-up matters more than the original answer.

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.

Picking up post #7: 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.

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.

post #12 answers the question as asked. The question underneath it is different.

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.

On post #10 — agreed on the reasoning, with one qualification.

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.