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EPedigree is an initiative that impacts the entire pharmaceutical supply chain. As of the beginning of 2008, 35 states – most notably and stringently California – have mandated that “the smallest saleable container” of any prescription drug sold must be serialized and then a pedigree generated and appended through each step on the supply chain. A Federal bill has been introduced in Congress in May, 2008 to provide similar mandates.
Obviously this is a very expensive and far-reaching compliance issue. The sheer volume of containers of prescription drugs sold in the US is huge – and getting larger each day.
OMA was called in to help a large generic pharmaceutical company to understand the regulations, create a strategy for compliance and payback, become a liaison to other companies and trade associations and be an integral part of the project team.
If you’re a pharma company, contract manufacturer or wholesaler / distributor and require compliance assistance on ePedigree laws – please contact us today. We can help – or at least suggest a direction for you.