Clinical perspective, offered as context rather than as advice. Worth answering the question that was asked rather than the one behind it. The narrow version usually has an answer; the broad version usually does not, and answering the broad one is how a thread stops being useful.
Dr.Martinez said:Worth answering the question that was asked rather than the one behind it.
Can confirm. Same sequence, different timescale. The detail I would add is minor and it is already implied above.
Dr.Martinez said:Worth answering the question that was asked rather than the one behind it.
Coming at Dr.Martinez’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.
If somebody has the primary source to hand I would rather cite it than paraphrase it.
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Browse GL BiochemOne concrete data point for the thread. Keep the original post as written when you update it, and add the correction underneath. An edited-away mistake is invisible to the next person who makes it.
One thing that is still open after Dr.Martinez’s answer:
What actually distinguishes 503A from 503B, in terms of what each may make and from what starting material?