Endotoxin testing in compounded injectables — looking for input

rick_sfbay said:

Resolution therefore closed the doors unevenly, and the asymmetry follows from the bulks lists.

Price comparison for compounded supply across sources I've used:

I use the 503B option — best balance of quality, cost, and legality. The brand price is insane but insurance can help if you qualify.

Following on from Dr.PeteFamMed — 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?

VendorMark said:

Price comparison for compounded supply across sources I've used: Source Monthly Cost Type Purity Verified Brand (Ozempic) $930 FDA-approved N/A…

Compounding pharmacy customer here with experience relevant to compounded supply.

I've ordered from 2 different compounding pharmacies over the past 2 years. 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 10 orders. I pay $121/month vs $1,291 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.

OP back with an update, since a thread like this is useless without one.

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.

Dr.EndoIndy said:

Compounding pharmacy customer here with experience relevant to compounded supply.

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.