Comment · Thu, April 30, 2020 · Natrium Health & Nootropics Depot
FDA's Letter to Tailor Made Compounding Pharmacy
What they were answering
varikonniemi · -3 points
It is someone's responsibility to prove some breach happened.
If you have a reliable source then you can only increase contamination by opening the sealed package, test it, and repackage it. Along with significantly increasing costs. Why would you not trust the source's ISO certificate?
This is why you test manufactured products to see if they comply, you don't make arbitrary standards that are impossible to meet. Do you remember the hemp tax act?
u/MisterYouAreSoDumb · Natrium Health & Nootropics Depot
It is someone's responsibility to prove some breach happened.
Is it? It's our responsibility here as unrelated parties to prove they were selling untested things? Why is it our responsibility to prove them wrong, and not their responsibility to prove they were right?
If you have a reliable source then you can only increase contamination by opening the sealed package, test it, and repackage it. Along with significantly increasing costs. Why would you not trust the source's ISO certificate?
No source is 100% reliable all the time. Full stop. Not a single one. You also can't trust any document from China. Not a single one. You have to test and verify it. This is not just a "good to have" either. It's an FDA requirement that they did not fulfill; hence the enforcement letter. Yes, it increases costs. That's how you run a business. People trust that you are doing what you need to ensure things being sold to them are real and pure. If you don't do those things, you are putting people in harms way. They did not even audit their suppliers to see if they were reliable.
Your firm receives raw materials and peptides from suppliers both domestically and internationally. However, your firm has never audited any of these suppliers.
That was specifically mentioned by the FDA. You can't just rely on the supplier COA if you have not even audited the supplier. You can't just see numbers on a page and accept them as fact without validation.
This is why you test manufactured products to see if they comply, you don't make arbitrary standards that are impossible to meet. Do you remember the hemp tax act?
Impossible to meet?!? They did not even test for the basic identity of raw materials they got in. You HAVE TO do that to be FDA compliant. It's not a choice. You have to have systems and processes in place to ensure what you are getting is correct, and you have to have systems and processes in place to validate they are telling you what you think they are. It's not a choice. It's the law. Yes, things like the hemp tax act were bullshit made in bad faith. I am not sure how that relates to the current cGMP guidelines for compound pharmacies, though. Those quality control rules are not in bad faith. Yes, they are expensive to follow, but that's why you have such high margins in the space. You know how much margins Tailor Made was making off something like CJC-1295? I do. It more than covers expenses needed to ensure things are correct. That's their job! If they don't do that, then why not just go direct to a Chinese lab off Alibaba and roll the dice yourself?