Last week the Pharmaceutical Distribution Security Alliance (PDSA) released a prospectus for the, as yet, unnamed non-profit organization that they are trying to kickstart to help govern supply chain interoperability of the Drug Supply Chain Security Act (DSCSA) solutions targeting the Enhance Drug Distribution Security (EDDS) phase that will go into effect in November of 2023 (see “PDSA’s Proposal for Governance of DSCSA Phase II Interoperability” and “PDSA Brainstorms Vision For DSCSA Governance Organization With Stakeholders”). You can download the prospectus here.Continue reading PDSA Releases Prospectus To Prospective Governance Group Members
Can President Trump, HHS Secretary Azar and Acting FDA Commissioner Sharpless eliminate/adjust/reinterpret any part of the Drug Supply Chain Security Act (DSCSA) to allow Florida, Colorado, Vermont, Maine or any other US state or territory to import drugs from foreign markets? Let’s take a closer look at what’s been going on recently with the idea of importing drugs from other markets in an attempt to help American citizens buy them at a lower cost.Continue reading Can Trump/Azar/Sharpless Eliminate Parts of the DSCSA to Enable Importation?
It’s time to assess the progress of the industry and the FDA in their quest toward the November 27, 2023 Drug Supply Chain Security Act (DSCSA) goal known as the Enhanced Drug Distribution (EDDS) phase…otherwise known as just ‘2023’ (see “EDDS: The New Data Exchange Requirements”). Let’s step back and look at where we have come and where we need to go.Continue reading DSCSA Schedule Assessment, July 2019
On November 27, 2019 the Drug Supply Chain Security Act (DSCSA) requires wholesale distributors to step up their supply chain security activities another notch. They are required to:Continue reading Is The FDA About To Delay Enforcement Of The Wholesaler’s 2019 Mandate?
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) 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”.Continue reading PDSA’s Proposal for Governance of DSCSA Phase II Interoperability
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
Last November pharma manufacturers selling into the U.S. market had to meet a big serialization and verification deadline under the Drug Supply Chain Security Act (DSCSA). Now, pharma wholesale distributors in the United States are facing their own important deadline this coming November. Remember how manufacturers had to scramble and go through a lot of pain to achieve compliance in time? Your friendly neighborhood wholesale distributors—big and small—are going through that now. And the problem is…they can’t do what they need on their own. They need all drug manufacturers to do something so that they can be compliant with the DSCSA in November.Continue reading DSCSA: What Wholesalers Want