lisa_labSD said:

One practical note: write down what you did and when, before you need it.

Agreed, and the size of the effect matters as much as its existence. Something real and small gets treated here as though it were real and decisive.

I would rather be corrected than agreed with, if it comes to it.

lisa_labSD said:

One practical note: write down what you did and when, before you need it.

This is exactly what I could not find anywhere else. I will report back once I have actually tried it.

Clinical perspective, offered as context rather than as advice. It helps to say which part of this you are uncertain about. A precise question gets a precise answer; a general one gets everybody’s favourite anecdote.

TrialNerd_Beth said:

It helps to say which part of this you are uncertain about.

This matches mine closely enough to be worth saying so out loud. Nothing to add that would improve it.

TrialNerd_Beth said:

It helps to say which part of this you are uncertain about.

Coming at TrialNerd_Beth’s question from a different direction. The shortage clause is the answer to the second question and it is a subtraction rather than an addition. Both exemptions forbid compounding something that is essentially a copy of a commercially available approved product. A product FDA has listed as in shortage is not treated as commercially available, so listing removed the objection that otherwise blocked compounding. It never created a permission; it withdrew a prohibition, which is why it evaporated the moment the supply fact changed.

Worth separating that from compounded supply, which this thread keeps folding into the same question. They behave differently and the advice does not transfer.