rick_sfbay said:The shortage clause is the answer to the second question and it is a subtraction rather than an addition.
Compounding pharmacy customer here with experience relevant to compounded supply.
I've ordered from 5 different compounding pharmacies over the past 18 months. The quality variation is real — purity ranged from 94% to 101% of label claim based on independent Janoshik testing.
My current compounder (a 503B facility) has been consistently 98-101% purity across 5 orders. I pay $136/month vs $1,206 for brand. The savings are substantial and the product is equivalent in my experience.
Re: compounded supply — this applies whether you're using brand or compounded. The clinical principles are the same.
Following on from ingrid_STO — 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?
raj_cambridge said:Compounding pharmacy customer here with experience relevant to compounded supply.
Compounded has been just as effective for me. If compounded supply is the concern, the COA from my 503B pharmacy shows 99.1% purity. Verified by Janoshik.
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Shop Reference StandardsClosing 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.
SarahChen_PharmD said:Compounded has been just as effective for me.
Agreed, and the enforcement dates were staggered by category — 503A first, 503B a few weeks later — because outsourcing facilities have manufactured inventory and clinic contracts to unwind while a 503A makes to order.