DSCSA deadline has been pushed back a year

The final implementation date for the Drug Supply Chain Security Act (DSCSA) has been set back a year after the FDA responded to pleas for more time, with the new deadline set for November 27, 2024.

Dubbed a "stabilisation period" rather than the usual "enforcement discretion" holidays that have affected earlier DSCSA implementation deadlines, the delay is intended not to allow trading partners to relax – rather, it is an opportunity to "implement, troubleshoot and mature" the systems that will need to be in place next year.

The DSCSA – now approaching a decade in the implementation phase since it was enacted in 2013 – requires trading partners in the pharma supply chain from manufacturers to pharmacies to install traceability systems that allow prescription medicines to be tracked at the pack level, using serialised codes.

The objective is that manufacturers can respond in real-time to queries about the legitimacy of a product, to improve the security of the supply chain and prevent counterfeit and otherwise illicit medicines reaching patients.

The FDA is adamant that by the new deadline trading partners must be able to share the necessary interoperable data electronically, saying: "FDA expects trading partners to use this stabilization period to build and validate interoperable systems and processes, manage products and data, and ensure continuity of the supply chain and product availability to patients. This period is not intended to provide, and should not be viewed as providing, a justification for delaying efforts to comply with the DSCSA."

The stabilisation period was announced alongside new guidance documents, including one on the requirements for wholesale distributor verification of so-called 'saleable returns' – the processes that need to be carried out to check the serialised unique identifiers of returned products before they can be placed into inventory for resale – and when investigating a suspect or illegitimate product.

The second guidance covers enhanced drug distribution security at the package level, and provides overarching advice on requirements and recommendations on attributes that a system to enable secure tracing of products at a package level should have.