April 17, 2017 - The United States has one of the safest and most efficient pharmaceutical supply chains in the world, and one of the most complex. Now, thanks to a federal law — and the collaborative work of pharmaceutical supply chain trading partners and regulators — the supply for medicines is even safer. By 2023, the delivery of medicines as we know it will be transformed because of these efforts.
Enacted in 2013, the Drug Supply Chain Security Act (the DSCSA, Title II of the Drug Quality and Security Act) was the result of nearly a decade’s worth of hard work on the part of my organization, the Healthcare Distribution Alliance (HDA), and its pharmaceutical distributor members. As the vital link in the healthcare system, between those that manufacture pharmaceuticals and the pharmacists and providers that dispense them, our members help sustain the supply chain. Distributors work around the clock to deliver more than 200,000 medicines and healthcare products daily, and are constantly thinking of new and innovative ways to ensure that the right medicines get to the patients who need them, both safely and on time. HDA is a proud supporter of Healthcare Ready for this same reason — both organizations are dedicated to ensuring patients and healthcare facilities have the medicines and products they need, when they need them. Our members routinely work with Healthcare Ready during times of disaster to make sure deliveries are made and patients have uninterrupted access to the medicines they require.
The DSCSA established one national solution to trace prescription medicines throughout the supply chain (referred to as “traceability” in the industry), ending an inefficient patchwork of varying “pedigree” laws that supply chain stakeholders had to follow in the states. It also called on the FDA to issue new, stronger federal licensure standards, and established new processes for stakeholders to identify suspect and illegitimate products in the supply chain. In short, by time the law is fully implemented in 2023, pharmaceutical stakeholders will have an even greater knowledge of product movement than ever before, with a greater ability to spot counterfeit products that may be introduced into the legitimate supply chain. More accurate product movement data also may help the industry respond even more efficiently to emergency situations.
The process to implement the DSCSA has been one of the most multifaceted and collaborative efforts that pharmaceutical supply chain stakeholders and federal and state regulators have undertaken. Pharmaceutical distributors’ unique position at the center of this supply chain — as well as their logistics expertise — has allowed them, through HDA, to form productive partnerships with their trading partners, industry stakeholder groups, customers and regulators (including the FDA and state Boards of Pharmacy) to overcome the complexities of the law and implement it as efficiently as possible. HDA has not only produced a range of materials on DSCSA implementation, but regularly brings together these various groups to tackle top-of-mind compliance challenges, through pilot studies, task forces and our annual Traceability Seminar. The 2017 seminar will convene this November 8-10 in Washington, D.C. — and with product serialization deadlines quickly approaching for pharmaceutical manufacturers, we expect this year’s event to once again feature attendees from across the supply chain.
Find out more about HDA’s efforts surrounding the DSCSA and pharmaceutical product traceability through our website.