Category Archives: EDDS

PDSA’s Proposal for Governance of DSCSA Phase II Interoperability

Independent, balanced, sector-neutral

Last week, the Pharmaceutical Distribution Security Alliance (PDSA) published two papers aimed at kickstarting the creation of a new non-profit organization that would accept the responsibility for setting up and executing governance over Drug Supply Chain Security Act (DSCSA) phase II interoperability (see “A Serious DSCSA Governance Organizational Proposal Emerges From PDSA”).  PDSA defines “DSCSA phase II” to be the same as what the DSCSA text calls the “Enhanced Drug Distribution Security” (EDDS) phase (see “EDDS: The New Data Exchange Requirements”).  The EDDS phase (err, Phase II of the DSCSA) starts on November 27, 2023.  In most informal conversations this phase is usually just referred to as “2023”. 

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A Serious DSCSA Governance Organizational Proposal Emerges From PDSA

PDSA Members (click image to enlarge)

Two days before the Drug Supply Chain Security Act (DSCSA) was signed by then President Obama, I published “DQSA: The U.S. Pharma Supply Chain Must Organize, Or Risk Failure”.  Under the heading “Who should organize and start the effort [to organize the industry around solutions to the DSCSA]?”, I wrote:

Continue reading A Serious DSCSA Governance Organizational Proposal Emerges From PDSA

5 Myths About The DSCSA In 2023

istock_67972853_smallerThere are a number of misconceptions floating around the industry right now about what will happen in November of 2023, when the Enhanced Drug Distribution Security (EDDS) phase mandated by the Drug Supply Chain Security Act (DSCSA) begins.  It is surprising where you hear some of these, but they are all based on mis-reads of the DSCSA law itself.  I’ll explain the myths, and then I will try to provide extracts from the DSCSA that expose them as myths. Continue reading 5 Myths About The DSCSA In 2023