Comment · Fri, May 1, 2020 · Natrium Health & Nootropics Depot
FDA's Letter to Tailor Made Compounding Pharmacy
What they were answering
varikonniemi · -1 points
No source does testing on each and every batch. This is what is needed if you want more assurance than the product and testing certificate the manufacturer gives for the batch. There is no reason not to trust ISO certification.
If they did not receive a COA for every used batch, then i would have a problem with their practices. If FDA tests a product, finds it contaminated, then you start investigating, and possibly remove the ISO certification status from the manufacturer if it is found the product was contmainated and testing faked.
When you mass produce products like pharma companies do, then i can accept stricter quality control rules as the batch sizes are completely different, logistics is completely different, and the potential for harm through quantity sold is completely different.
This is the same as you don't require a farm to test the milk they take from their cows and sell locally. But once you put thousands of gallons in packages and mass distribute around the country, you should test each batch.
u/MisterYouAreSoDumb · Natrium Health & Nootropics Depot
No source does testing on each and every batch.
Then they are a shitty company. Period. If you don't test every batch, then there is no reason for you to exist as a company. Skip-lot testing is bullshit. Even when it is allowed by the FDA, you still need to run tests on every single batch for a while to qualify them. Then you need to go and inspect and audit the suppliers before you can trust they will be consistent. Tailor Made did none of it. No testing at all. No auditing of the suppliers. No processes or procedures to define what is and is not acceptable from a quality systems standpoint. There is no excuse.
This is what is needed if you want more assurance than the product and testing certificate the manufacturer gives for the batch. There is no reason not to trust ISO certification.
ISO does not mean what you think it means. You get ISO certifications per process and per test. A lab can be ISO certified to test vitamin C, but not other compounds. You don't just get one ISO certification and now your whole organization is good to do whatever it wants. You are only ISO certified for specific things. I guarantee you Tailor Made's suppliers were not ISO certified for the CJC-1295 or LGD-4033 they were selling. They would not even know, though. They did not audit and inspect their suppliers!
If they did not receive a COA for every used batch, then i would have a problem with their practices.
Supplier COAs are meaningless; absolutely meaningless. Suppliers lie all the time. It's the norm, not an exception. Even if they are not purposely lying, they are cutting corners and don't understand the science behind what they are doing. This is what audits and inspections are for. You need whole systems in place to qualify your suppliers. You need SOPs and investigations to scientifically and empirically measure what can and cannot be trusted. Would you buy bulk steel from a Chinese company and build a skyscraper with it without testing its structural integrity first? Hell no! Why would we trust things we are INJECTING into our bodies without testing?!?
If FDA tests a product, finds it contaminated, then you start investigating, and possibly remove the ISO certification status from the manufacturer if it is found the product was contmainated and testing faked.
The FDA has no part in ISO. They cannot and do not remove ISO certifications...
When you mass produce products like pharma companies do, then i can accept stricter quality control rules as the batch sizes are completely different, logistics is completely different, and the potential for harm through quantity sold is completely different.
Bullshit. They were selling drugs. Period. If you are selling drugs, you have to follow drug quality testing regulations. Size of the company doesn't matter. Do we let small oil drilling companies break environmental laws because it would be too costly for them to do it like the big guys? Hell no! Regulations are in place to protect people's health. Dealing with the costs of that is part of running a business. Tailor Made had PLENTY of margins in the products they were selling to do it.
This is the same as you don't require a farm to test the milk they take from their cows and sell locally. But once you put thousands of gallons in packages and mass distribute around the country, you should test each batch.
This is NOT a fucking farmers market milk seller!!!! This is a drug compounding pharmacy selling unapproved peptides that doctors were prescribing to their patients!!! There is NO EXCUSE for not testing your drug products you are selling to people. There are no provisions in the FDA regulations that say "You need to have processes and procedures in place to ensure you are not poisoning customers.... unless you are small. Then it's cool. YOLO!" Do you really think we should have more lax regulations on smaller drug pharmacies? Like we should just roll the dice at a small pharmacy, and that metformin we are getting from them could be impure and full of mercury, and that's cool? Ohh, don't worry little pharmacy, we didn't expect you to do all those hard things like MAKING SURE WHAT YOU ARE SELLING IS THE RIGHT THING! No, we understand that's soooooo expensive to do things right. You are small, so it's cool if you poison your customers. Walgreens, though? No, they have to follow the rules. They are bigger... Come on!