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The integrity of the pharmaceutical supply chain is controlled by a specific federal law, Title II of the Drug Quality and Security Act of 2013, also known as t
by PeanutNore 8y ago
The integrity of the pharmaceutical supply chain is controlled by a specific federal law, Title II of the Drug Quality and Security Act of 2013, also known as the Drug Supply Chain Security Act.
The potential liability they would be exposing themselves to if Amazon treated their drug supply chain the way they treat standard 'Fulfilled by Amazon' products would hopefully prevent something like that from ever happening.
- owenmarshall 8y agoThe FD&C act imposes strict liability on violations, and criminal prosecutions for mislabeling and adulterating drugs have extended to company officers that were completely unaware of the actions their subordinates had taken. Amazon isn't stupid: they know _exactly_ where they can play it fast and loose in order to maximize profit and where they must operate under strict regulation. This isn't the former.
- refurb 8y agoYes, and a part of that is track and trace (aka serialization). Each unit has a unique identifier and must be tracked from manufacturer to patient.[1] It’s a big infrastructure lift so it’s still being implemented. [1]https://www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/DrugSupplyChainSecurityAct/ucm427033.htm https://www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyC...