TrialNerd_Beth said:My experience ordering cross-border ordering internationally: I've ordered from an Australian compounder.
This matches mine closely enough to be worth saying so out loud. Nothing to add that would improve it.
From the other side of the consultation, briefly. The useful move here is to separate what is established from what is widely repeated. Those two sets overlap less than the confident tone of most write-ups suggests, and the second set is where nearly all the disagreement on this board comes from.
Dr.LeslieOBGYN said:The useful move here is to separate what is established from what is widely repeated.
Same experience, arrived at from the opposite direction.
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Shop Reference StandardsDr.LeslieOBGYN said:The useful move here is to separate what is established from what is widely repeated.
Coming at Dr.LeslieOBGYN’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.
Correct me if the detail matters more than I have assumed.