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The Healthcare Distribution Alliance (HDA) released a statement from President and CEO Chester “Chip” Davis, Jr., on the Food and Drug Administration’s (FDA) issuing of an exemption for eligible trading partners to comply with the final requirements of the Drug Supply Chain Security Act (DSCSA).
“HDA and our pharmaceutical distributor members applaud the FDA’s decision to grant an exemption for the DSCSA’s enhanced drug distribution security (EDDS) requirements for eligible trading partners. While many in the supply chain have made significant progress throughout the stabilization period, some are still struggling to establish data connections. Given the interdependency of the pharmaceutical supply chain, FDA’s phased-in approach will allow supply chain partners to better align their data exchange processes to ultimately achieve full implementation and also acknowledges the progress made thus far."
“HDA and other industry groups, such as the National Association of Chain Drug Stores (NACDS), as well as 21 members of Congress, recently advocated for additional time to stabilize the complex processes necessary for compliance. In our role as educators and conveners, HDA’s Traceability Seminar in August featured representatives from the FDA who listened to the industry's concerns and provided clarification. Ultimately, the FDA made a sound decision based on stakeholder input; we thank the agency for acting with the best interests of patients in mind."
“As we continue to make progress toward full DSCSA implementation, HDA and our distributor members will remain engaged with our public- and private-sector partners to share information and education, as we move toward our shared goal: helping patients and providers safely access the medicines they need.”
