The Drug Supply Chain Security Act (DSCSA) was enacted in 2013 as an industry-wide collaboration designed to protect consumers from exposure to counterfeit, altered or illicit drugs. The final milestone of the 10-year implementation is fast approaching (November 27, 2023) and it marks a potential watershed moment for the pharmaceutical data landscape. If all goes as planned, that is when information about the lot, expiration and chain of custody (i.e. who touched the product and when) will be captured for EVERY saleable pharmaceutical unit. When I discuss this with friends outside the industry, the most common response is "I can't believe they aren't doing that already!" Most believe that because pharmaceutical products are well controlled and often very expensive, there is maximum transparency about their movement and whereabouts. Sadly, this is not so. Traditional supply chain data lacks specificity about the age and expiration of the product on the shelves – often valued at millions or even billions of dollars! But the misconceptions about this initiative aren't limited to industry outsiders. Many experts I've spoken to are expecting that serialized pharmaceutical data being collected as part of DSCSA will be shared with them automatically as part of their participation in the supply chain. Again, sadly, this is not the case. While the DSCSA provides new transparency to downstream supply chain participants, those upstream (i.e. manufacturers and wholesalers) will need to work with their trading partners to obtain access to this new, golden data. It's easy to envision how this access to unit-level serialization could change the game for manufacturers -- returns forecasting, demand planning, rebate/chargeback reconciliation, recall management, etc. -- but an invitation to the new data party will require a ticket and, like any good party, admission’s not free. VineMeds is providing insights to constituents at all levels of the pharma supply chain, helping them make informed decisions about the value and uses of this new, game-changing data. Don't delay to engage and at least challenge your assumptions about what serialized data could mean for you. Contact us today to learn more.
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