Comment · Thu, April 30, 2020 · Natrium Health & Nootropics Depot
FDA's Letter to Tailor Made Compounding Pharmacy
What they were answering
varikonniemi · 17 points
Not one independent compounding pharmacy would clear such an inspection. And this is the reason almost none is left, the authorities want them gone so that the consumer is totally at the mercy of pharma giants.
While they ignore all the insane errors pharma companies make, nothing in the class of same severity has ever happened in a compounding pharmacy. Yet the drug companies get to continue by paying a small fine. But the compunding pharmacy sees judgements that put them out of business. Before even doing anything wrong except breach policy (contrasted to breach product safety, like pharma giants do regularly).
u/MisterYouAreSoDumb · Natrium Health & Nootropics Depot
I completely understand your frustration with the way the FDA tries to kill parts of the industry. However, you have to realize they have a point with some of it. If Tailor Made is getting things made for them in China, then doing zero quality control or analytical testing to ensure they are even the right compound, much less pure, then how does that help anyone? How does that not play into the FDA's hand that the industry can't regulate itself? The FDA wants to destroy anything that is not a traditional pharma company. They have for decades. Does anyone remember the FDA raiding stores at gunpoint in the early 90s for CoQ10? The DSHEA put the breaks on that, though. Left to their own devices, the FDA would grab more and more power till they stifled out everyone not in a traditional pharma company. Places that do zero quality control like Tailor Made play right into their hand. They use that as justification for Congress allowing them to take more control. They tell everyone they have to protect us from the big bad companies. If people in the industry don't take that seriously, then they will get their wish. Fuck Tailor Made for playing into their hand. You know how much margins there are on the peptides and SARMs they are selling?!? It's nuts! They can't be fucking assed to spend some of that money ensuring their customers are not getting fake or impure shit?!? I was warning people about how Tailor Made was not testing anything a while back. This is not the first time the FDA has dealt with them.
https://www.fda.gov/media/123771/download
That's from 2018!
OBSERVATION 9
Drug product component testing is deficient in that at least one specific test to verify the identity of each component is not performed.
a.) Specifically, your firm does not perform any identity testing on incoming raw materials.
b.) Your firm receives raw materials and peptides from suppliers both domestically and internationally. However, your firm has never audited any of these suppliers.
So they were doing ZERO testing for their peptides. No ID or assay. They did not even audit their suppliers. The FDA warned them about this back in 2018, and they didn't change shit. These are the bad actors in the industry that will make it harder for the good ones to exist. These are the companies that the FDA will use as justification to grab more power. It's specifically because shitty vendors in the space are not testing that the FDA can justify actions like this. If the community and the industry does not step up to show it can properly self-regulate, the FDA is going to keep doing it.