Dr.DermMIA said:Worth adding the genuine exception, because it is real and narrow: a change made for an identified patient where the prescriber determines it produces…
This is my experience too, for whatever a second data point is worth. Posting only so the count is not one.
Dr.DermMIA said:Worth adding the genuine exception, because it is real and narrow: a change made for an identified patient where the prescriber determines it produces…
Coming at Dr.DermMIA’s question from a different direction. They are two different exemptions from the same federal requirements and they buy different things. A 503A pharmacy is regulated primarily by the state board, needs a patient-specific prescription, is exempt from CGMP, and may use a bulk substance that has a USP monograph, is a component of an approved drug, or appears on the 503A bulks list — three independent doorways. A 503B outsourcing facility registers with the FDA, is inspected on a risk basis, must comply with CGMP, may compound for office stock without a patient-specific prescription, and has one doorway to a permitted bulk substance: the 503B bulks list, or the drug shortage list.
Adding the numbers, since they settle part of this. 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.
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Browse GL BiochemFollowing on from Dr.DermMIA — and this may be the naive question:
Why a shortage listing created a legal pathway at all, since a shortage is a supply fact rather than a permission?
dan_philly said:For anyone reading later: the numbers in this thread are worth checking against a primary source before you act on them, including mine.
Careful with the causal language. Two things moving together in a period when five things changed is not a mechanism, and stating it as one makes the thread less useful to somebody reading it later.
Worth separating that from compounded supply, which this thread keeps folding into the same question. They behave differently and the advice does not transfer.