From the other side of the consultation, briefly. The version of this that has an answer is narrower than the version being asked. Narrow it and it becomes tractable; leave it broad and the thread will produce nine confident and incompatible replies.
BiostatsBrad said:Say what you would expect to see if you were wrong, before you look.
Coming at BiostatsBrad’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.
Adding the numbers, since they settle part of this. Worth stating the units and the reference range whenever you post a number here. A large fraction of the apparent disagreement in these threads is two people using different units and both being right.
If somebody has the primary source to hand I would rather cite it than paraphrase it.
Trusted third-party HPLC & mass spectrometry analysis. Verify peptide purity with the lab the community relies on. Independent. Accurate. Transparent.
Verify Your PeptidesEst. 1998. The synthesis house behind the vials you send for testing. ISO 9001 and cGMP certified, 1,500+ staff, batch-specific COA with every order.
Browse GL BiochemOne thing that is still open after BiostatsBrad’s answer:
Why a shortage listing created a legal pathway at all, since a shortage is a supply fact rather than a permission?
Moderator note: reminder that nothing in this thread is medical advice, and that clinical claims need a source. No action needed from anybody.