Some members of the US pharmaceutical supply chain are not waiting for the FDA to make the next move (see “DSCSA: Will 2020 Be FDA’s Year To Leap Forward?”). Instead, they are proactively organizing and setting the standards that will most likely be used to meet the requirements of the Enhanced Drug Distribution Security (EDDS) phase of the Drug Supply Chain Security Act (DSCSA), which goes into effect on November 27, 2023. Forward motion has been made over the last month on two fronts: The DSCSA governance organization and the Verification Router Service (VRS).
Continue reading DSCSA: Industry Moves Forward →
Back in 2010 I posted an RxTrace essay called “California Pedigree Law: Historic Change To Commerce” that pointed out the significant change that was then scheduled to occur once the California law was to go into full effect in 2016. Of course, that state law was preempted by the Drug Supply Chain Security Act (DSCSA) back in 2013 so we never actually experience that change. But what about the DSCSA? Will it change the way commerce happens in a historic way? Let’s take a look.
Continue reading DSCSA: Historic Change To Commerce →
Last week the Pharmaceutical Distribution Security Alliance (PDSA) held a workshop for interested stakeholders to brainstorm just how their proposed independent, balanced and sector-neutral organization might meet their vision. This was the follow-on meeting tied to the publication of two documents last month that provided their “vision” and the actual proposal for the organization (see “PDSA’s Proposal for Governance of DSCSA Phase II Interoperability”).
Continue reading PDSA Brainstorms Vision For DSCSA Governance Organization With Stakeholders →
DISCLAIMER: RxTrace contains some of the personal thoughts, ideas and opinions of Dirk Rodgers. The material contained in RxTrace is not legal advice. Dirk Rodgers is not a lawyer.
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