IWLA and the  Pharmaceutical Distribution Security Alliance (PDSA) has submitted comments to the U.S. Food and Drug Administration’s (FDA) on FDA’s draft guidance for industry entitled “Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act.”

IWLA is a member of PDSA which was formed in 2011 and is a multi-stakeholder coalition with membership that spans the entire spectrum of the U.S. pharmaceutical distribution system, including manufacturers, repackagers, wholesale distributors, third-party logistics providers, and pharmacies.

PDSA’s comments raised four overarching themes:

The systems and processes that industry leverages to comply with the DSCSA requirements on November 27, 2023, will continue to evolve in the months and years to come; the sole focus of industry and FDA between now and November 27, 2023 should be on the essential functionalities to enable compliance.

PDSA members support standardized communication between Regulator and Industry systems but do not anticipate or support any direct access to internal trading partner repositories or systems.

PDSA does not view the DSCSA “system” as a single technology.

Heterogeneous cases and mixed totes should be more explicitly discussed in the guidance.

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