Dr.ObesityMed said:They are two different exemptions from the same federal requirements and they buy different things.
Filing a mild objection. Mild because I might be wrong; an objection because nobody has addressed the case that does not fit. Import rules are jurisdiction-specific and this board keeps giving US-shaped answers to non-US questions. What is a personal-import allowance in one country is a controlled-import offence in another.
Worth separating that from compounded supply, which this thread keeps folding into the same question. They behave differently and the advice does not transfer.
Adding the numbers, since they settle part of this. Two things anyone can check: a state licence number for a 503A, and an FDA outsourcing-facility registration for a 503B. Both are publicly searchable, and a pharmacy unwilling to give you either has answered the question.
HPLC_Greg said:Import rules are jurisdiction-specific and this board keeps giving US-shaped answers to non-US questions.
There is a second half to this that has not been said yet. Resolution therefore closed the doors unevenly, and the asymmetry follows from the bulks lists. For 503B the shortage clause was the only route to these molecules, so that route shut completely. A 503A pharmacy can still argue a doorway via "component of an approved drug" — but only for the substance in the form present in the approved product, which is exactly where the base-versus-salt argument lives, and it does nothing about the copy restriction, which came back into force on resolution.
Happy to go further on any of that.
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Shop Reference StandardsFollowing on from lisa_labSD — 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?
Closing the loop on my own question.
The bulks-list asymmetry was the piece I had missed entirely. It explains why one of my two pharmacies is still arguing it can supply and the other simply stopped.