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Pharmaceutical Traceability

HDA is now leading industry efforts to implement the 2013 Drug Supply Chain Security Act (DSCSA) that replaced a 50-state patchwork of pedigree requirements with one federal solution to trace prescription medications through the supply chain.

This groundbreaking law:

  • Clarified and consolidated supply chain regulations, increasing the efficiency and safety of the supply chain. Beginning in January 2015, manufacturers and distributors were required to adhere to enhanced product tracing requirements, with pharmaceutical dispensers following in July later that year. Over the next 10 years, a single system of federal electronic, unit-level traceability requirements will be phased in to apply to the entire supply chain.
  • Strengthened distributor licensure standards across the United States. Through the DSCSA, the FDA must issue new federal licensure standards. Once finalized, states have two years to adopt these standards. This approach is intended to create greater uniformity across states and enhance federal authority, while enabling states to maintain their authority to issue licenses and partner with FDA in enforcement efforts. 
  • Established new processes for identifying suspect and illegitimate products in the supply chain. As required by the law, in June 2014, FDA released draft guidance to help supply chain trading partners more readily identify, quarantine and investigate suspect and illegitimate products. It also seeks to enhance the process for manufacturers, distributors and others to notify the agency of the existence of potentially dangerous products in the supply.

Today, HDA is leading the supply chain efforts to implement the DSCSA. This implementation process has been one of the most collaborative efforts that pharmaceutical supply chain stakeholders and federal and state regulators have undertaken in recent history. Leveraging the deep knowledge and expertise HDA members bring to the pharmaceutical supply chain, HDA has helped form productive partnerships with industry stakeholder groups, customers and regulatory agencies — including the FDA and state Boards of Pharmacy — and has served as a forum for members and other professionals to address critical technology and compliance questions.

Throughout implementation, HDA has fostered knowledge and collaboration through educational programs, webinars, seminars, and product offerings, as well as a toolkit of supply chain materials touching on a range of implementation topics.

Having successfully met past DSCSA implementation milestones, HDA is now coordinating with members and others to conduct pilot studies to understand the technologies and processes required to effectively and efficiently implement future DSCSA requirements. Specifically, to meet a 2019 deadline, HDA worked with EY (formerly Ernst & Young) to complete a pilot study for distributors and manufacturers to examine different methods of verifying product identifiers.

Traceability Timeline

Click on graphic to enlarge. 

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