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HDA Statement on FDA’s Drug Supply Chain Security Act-Related Enforcement Discretion

October 22, 2020

ARLINGTON, Va. — In response to the Food and Drug Administration’s (FDA) decision to extend enforcement discretion related to certain Drug Supply Chain Security Act requirements, the Healthcare Distribution Alliance (HDA) released the following statement.

“We are pleased that FDA extended its enforcement discretion related to processing serialized saleable returns, particularly given the agency’s hard work on the COVID-19 response and vaccine development. Recent data collected by the HDA Research Foundation support FDA’s decision; with the industry’s unprecedented response to the COVID-19 pandemic a high priority, we have seen some of the implementation work around this deadline impacted due to this public health crisis.

“Rest assured, industry, and HDA as its convener, will work to leverage the immense effort, learnings and investments made to date to comply with the serialized saleable return deadline as we work toward the ultimate goal of 2023 DSCSA interoperability.”

ABOUT THE HEALTHCARE DISTRIBUTION ALLIANCE

The Healthcare Distribution Alliance (HDA) represents primary pharmaceutical distributors — the vital link between the nation’s pharmaceutical manufacturers and pharmacies, hospitals, long-term care facilities, clinics and others nationwide. Since 1876, HDA has helped members navigate regulations and innovations to get the right medicines to the right patients at the right time, safely and efficiently. The HDA Research Foundation, HDA’s non-profit charitable foundation, serves the healthcare industry by providing research and education focused on priority healthcare supply chain issues.

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