Regulation within the pharmaceutical industry is adapting once more as illustrated by two new guidances released under the FDA Drug Supply Chain Security Act (DSCSA). The DSCSA was enacted in 2013 with the intention of tightening security measures among entities in the pharmaceutical supply chain. These measures aim to prevent counterfeit and illegitimate drugs from penetrating the market.
One of the pivotal aspects of the DSCSA is the requirement to electronically track the movement of prescription drugs at the package level, thus providing a clear route of product movement right through the supply chain.
The new guidances are tools put forward to help supply chain partners adhere to the requirements of the DSCSA, particularly the move towards electronic tracking. The hope is with stricter measures and clearer guidance, the pharmaceutical supply chain can become more transparent and secure, ultimately elevating the safety measures for end consumers.
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