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HDA Statement on FDA Distributor Licensure Proposed Rule

February 4, 2022

Arlington, Va. — The Healthcare Distribution Alliance (HDA) released the following statement from President and CEO Chester “Chip” Davis Jr., regarding FDA’s proposed rule, issued as required by the Drug Supply Chain Security Act (DSCSA), entitled “National Standards for Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers.”

"HDA has long supported thorough, rigorous and uniform standards for state licensing of healthcare distributors and third-party logistics providers to help ensure that criminals do not infiltrate the supply chain and unlawfully gain access to prescription medications.

"While we are continuing to analyze the proposed standards, HDA is pleased that FDA has recognized the need for a uniform licensing framework across all 50 states and has reinforced the DSCSA’s elimination of the patchwork of state requirements that currently exists.

"Healthcare distributors anticipate that once the rules are finalized, they will enhance the security and efficiency of the supply chain and expedite the delivery of vital medicines, vaccines and healthcare products to practitioners, dispensers and, ultimately, the patients who need them.

"HDA looks forward to taking a closer look at the proposed standards to fully understand the requirements and their impact on the supply chain and will provide public comments accordingly.”

For more information about the DSCSA, visit HDA.org/DSCSA.

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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 nonprofit charitable foundation, serves the healthcare industry by providing research and education focused on priority healthcare supply chain issues.

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