sophie_paris said:No disagreement, though it depends on where somebody is starting from, and this thread has been assuming a starting point nobody stated.
Mine went the same way, slower. I had assumed I was the exception until I read this.
sophie_paris said:No disagreement, though it depends on where somebody is starting from, and this thread has been assuming a starting point nobody stated.
Adding the part of the answer the thread has not reached. 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.
The figures, for anyone assembling their own picture. Practical: whatever you change, write down the date and the reason. In three months the reason is what you will have forgotten, and the reason is what makes the record worth having.
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View ResultsOne thing that is still open after sophie_paris’s answer:
What actually distinguishes 503A from 503B, in terms of what each may make and from what starting material?
stefan_berlin said:Practical: whatever you change, write down the date and the reason.
This is where I part company with the consensus forming above. Pushing back on the consensus forming here. Consistency is not the same as correctness, and a board that agrees with itself quickly is usually agreeing with the first person who sounded certain.
Correct me if the detail matters more than I have assumed.