US Drug Supply Chain Security Act How the US Drug Supply Chain Security Act Impacts Manufacturers Catering to American Markets
The US Drug Supply Chain Security Act and the EU Falsified Medicines Directive both contain similar basic requirements in terms of serialization. However, while the overall objective – a safer drug supply chain – is the same on both sides of the Atlantic, the respective regulations differ widely in many aspects.
Both, US and EU, will require unique product identification at sales unit level in human-readable format and as a machine-readable data carrier using GS1 standards in form of a 2D bar code or data matrix. These need to be printed on the outer unit level packaging and verified before product enters the supply chain. Given that serialization-readiness in both markets is worryingly low, manufacturers need to start acting now in order to be compliant on time as there are few qualified solution vendors on the market.
The Deadlines: Big Bang vs Phased Implementation
Even though the US Food and Drug Administration (FDA) has announced a potential grace period of one year, the official deadline for serialization of sale units and homogenous cases officially remains November 2017. As many drug manufacturers catering to the US market still have no future-proof serialization solution in place, the industry welcomed this respite. However, this delay is likely to entail a complete zero-tolerance approach in 2018 as anyone not in compliance would technically have been in violation of the law for a full year.
While scrambling to meet deadlines however, drug manufacturers need to remember that serialization affects all aspects of an organization, from Overall Equipment Effectiveness (OEE) to Standard Operating Procedures (SOPs), IT systems and other mission-critical aspects. To reduce impact on production lines during and after implementation, you will need a serialization solution that is interoperable with existing line equipment and devices of your brand of choice. Avoid vendor-lock for better scalability. You should also look for a solution that allows for easy changeovers with minimal impact on efficiency and risk for human error.
The proximity of the deadlines can be an advantage as some requirements are similar. While the Falsified Medicines Directive (FMD) 2011/62/EU will immediately be applicable in its entirety from February 2019, the US have opted for a phased approach with different milestones for different supply chain partners. The 11/2017 deadline applies to serialization at unit level and for homogenous cases. Aggregation is likely to be a business requirement from 2019 to manage product returns. Major US wholesalers have already sent letters to the manufacturers informing them that aggregation is going to be expected. It is important to keep this in the back of your mind when choosing a serialization solution today: in the future, your platform might need to be able to automatically handle more processes than ‘just’ serialization, for instance tamper-evident packaging in the EU.