From the other side of the consultation, briefly. Start from the measurement rather than the conclusion. Almost every disagreement here turns out to be two people measuring different things and comparing the numbers anyway.
Dr.PulmRoch said:Start from the measurement rather than the conclusion.
Adding a me-too, because a thread of one person's experience is not much use.
Dr.PulmRoch said:Start from the measurement rather than the conclusion.
Coming at Dr.PulmRoch’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.
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Browse GL BiochemThe figures, for anyone assembling their own picture. For anyone reading later: the numbers in this thread are worth checking against a primary source before you act on them, including mine. Half the figures circulating in this community trace back to a secondary summary that dropped a qualifier.
Happy to go further on any of that.
Following on from Dr.PulmRoch — and this may be the naive question:
What actually distinguishes 503A from 503B, in terms of what each may make and from what starting material?