DSCSA Compliance – Who should be Concerned with the Drug Supply Chain Security Act?

Even though the deadline for DSCSA compliance is only 6 months away, there is still some uncertainty as to who exactly will be concerned when by its requirements.

As the name Drug Supply Chain Security Act (DSCSA) implies, all parties of the drug supply chain will eventually have to be compliant with drug serialization and traceability or reporting requirements. But how and when am I concerned you may ask? In a previous article, we have broken the US Food and Drug Administration (FDA)’s program down into more digestable pieces to help you see clearer about the when.

By now it is clear that pharmaceutical companies as marketing authorization holders (MAHs) as well as contract manufacturers (CMOs) and drug packaging companies will need to be serialization-ready by November this year. Other supply chain partners like repackagers (2018), distributors (2019) and dispensers (2020) will have to follow suit to ensure all serialization, traceability and reporting requirements set out by the Drug Supply Chain Security Act (DSCSA) are met by 2023.

A lesser-known fact is that even not-for-profit organizations operating under US law that dispense medication free of charge, like disaster-relief or other charities, will have to comply with the Drug Supply Chain Security Act and meet the DSCSA deadlines. Imposing costly compliance investment or time-consuming reporting requirements on organizations that often struggle to raise enough funds to be operational might at first sight seem counterproductive to their charitable cause. However, we need to remember the reasons behind legislations like the Drug Supply Chain Security Act, the Falsified Medicines Directive, the Saudi Drug Code, and others: protecting patients by fighting counterfeits. So it only makes sense to extend DSCSA requirements to those organizations taking care of the most vulnerable who rely on the safety of the medicines they are given.

However, in some cases, “the US Food and Drug Administration does make exceptions regarding the provision of tracing information in order to not jeopardize life-saving emergency treatments. Indeed, an FDA Guidance Document detailing “Requirements for Transactions with First Responders” states that the FDA will not take action against dispensers who provide drugs “in small quantities or on a periodic basis” for example to nongovernmental fire/rescue and ambulance services and who “may lack the resources to provide product tracing information”.