The pharmaceutical industry is currently undergoing a paradigm shift as it prepares to meet the new requirements of the U.S. Drug Supply Chain Security Act (DSCSA) to implement interoperable, aggregation-ready track-and-trace systems by November 2023.
Having access to end-to-end track-and-trace systems will allow supply chain members to streamline operations and prevent the spread of counterfeit medicines on the market. These systems will be immensely valuable in zeroing in on illegitimate drug products and understanding their origin and how they entered the supply chain.
However, if pharmaceutical supply chain members themselves take part in drug counterfeiting, the serialization and data-reporting guidelines will fall flat. Hence, to establish supply chain members as trustworthy, the U.S. Food and Drug Administration (FDA) has introduced many provisions to provide a critical legal enforcement mechanism to prevent the entry of illegitimate drug products into the supply chain by closing it off to disreputable companies.
While a great deal of attention is being paid to the aggregation and track-and-trace requirements, there hasn’t been much discussion about what the new requirements mean for Authorized Trading Partners (ATPs).
With the compliance deadline steadily approaching, now is an excellent time to take stock of what ATPs can expect in the coming months and what their responsibilities will be.