Comment · Thu, April 30, 2020 · Natrium Health & Nootropics Depot
FDA's Letter to Tailor Made Compounding Pharmacy
What they were answering
throwaway2676 · 8 points
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.
Sure, that part is all fine, and taking the FDA at their word (a huge ask, mind you), I agree with saying "Fuck you, TMC, get your shit in line."
However, I'm mainly focused on this bit:
During the inspection, the FDA investigators noted that drug products produced by your firm failed to meet the conditions of section 503A. For example, the investigators noted that your firm compounded drug products using Follistatin, GHRP-2, GHRP-6, Endurobal, AOD 9604, BPC 157, Bremelanotide (PT-141), Cerebrolysin, DSIP, Epitalon, GHK-Cu, IGF1-LR3, Ipamorelin, LL-37, Melanotan II, PEG-MGF, Selank, Semax, CJC 1295, SARMS, LGD-4033, and MK 677. Drug products compounded using these bulk drug substances are not eligible for the exemptions provided by section 503A(a) because they are not the subject of an applicable USP or NF monograph, are not a component of an FDA-approved human drug, and do not appear on the 503A bulks list.
They are saying no compounding pharmacy can make any of those substances. So even with a fucking doctor's order, there is no "legitimate" way to get many of the safest and most helpful peptides. Not until our FDA/big pharma overlords decide we are allowed to (don't hold your breath).…
u/MisterYouAreSoDumb · Natrium Health & Nootropics Depot
I agree. It's fucked up. Trust me, I had to shut my fucking company down because of this. Ceretropic is no more because of the bullshit in this country. So nobody is more frustrated than me. I fought for years for this. I get it. However, my other fight is for proper lab testing and quality control. We HAVE TO get this industry to step up, or there won't be an industry left in the future. We have to hold companies accountable for proper lab testing and quality control. We just have to.