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On November 27th of 2013 when President Obama signed into law the HR3204 - the Drug Quality and Security Act, it was the result of many years of discussion and past attempts to establish a US centric law based upon securing the drug supply chain in an effort to prevent the entry of falsified medicinal products into the supply chain.

In the interim years before this became an actual reality, many state laws were either enacted, or were pending, as local focused attempts to put state level controls in place to secure their own supply chains.

One of the first things that HR3204 did was to make these local laws null and void so that one national program would establish comprehensive standards aimed at providing a consolidated approach to the anti-counterfeiting and control of medicinal products.

The two largest states that actually had laws that were on their books were California and Florida. California has now sent official notification that they will repeal, or withdraw their state law, but at the time of writing this Blog entry I believe Florida still has to take this important step.

Although there is now a national law it is still only a very early step towards achieving total compliance as the implementation period is 10 years and the FDA is now in the process of soliciting input on major items, like the recommended messaging system, e-Pedigree formats, etc.

I would be interested to hear from any Blog readers that work within the life sciences industry their opinions on how they see this playing out and if perhaps this will be the final solution/approach to securing the drug supply chain?

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Peter Norton is a senior logistics and supply chain manager and consultant to the life science industry, with extensive experience in both the domestic US and global markets.

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