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:
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.
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HDA Guidelines and Documents
Brian Waldman, Esq., MBA, Arent Fox LLP; HDMA 2015 Distribution Management Conference
Dr. Connie Jung, FDA; HDA 2014 Traceability Seminar
Dr. Connie Jung, FDA; HDMA 2014 Business and Leadership Conference
Scott A. Mooney (McKesson Corporation); Brad Pine (Smith Drug Company); and Heather Zenk (AmerisourceBergen Corporation); HDMA 2014 Business and Leadership Conference
Slide from FDA Webinar, "FDA Perspectives on Implementation of the Drug Supply Chain Security Act"
Julie Kuhn (H. D. Smith); Scott A. Mooney (McKesson Corporation); and Heather Zenk (AmerisourceBergen Corporation); HDMA 2014 Distribution Management Conference
Devin Boerm, HDA; HDMA 2014 Distribution Management Conference
Brian Waldman, Esq., Arent Fox LLP; HDMA 2014 Distribution Management Conference
Drugs sold or designated for sale in other countries likely will not conform with the DSCSA, exposing the U.S. supply chain and patients to unnecessary health risks without the promise of reduced costs for prescription drugs. That is why HDA strongly opposes prescription drug importation policies. Get the facts.