The Drug Supply Chain Security Act (DSCSA) comes into full effect in only six months’ time, having been originally signed by President Obama in 2013. This will give more authority to the FDA to regulate the drug manufacturing process, ensuring each drug product is traceable from start to finish.

As a CDMO we encouraged our customers to onboard sooner rather than later to ensure a smooth transition come the deadlines.

This new level of transparency will make harmful or counterfeit prescription drugs more visible in the supply chain, and thus make it possible to remove them before they reach the consumer.

Staffan Widengren, director corporate projects at Recipharm, spoke to World Pharma Today on the difficulty of implementing new serialisation processes with only six months left to go, and gives advice to manufacturers who are behind in their preparations.

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