Tag Archives: DSCSA

Governance

PDSA Brainstorms Vision For DSCSA Governance Organization With Stakeholders

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 →
Aggregation

An Aggregation ‘Discussion’

1 Comment
Trade item, logistics unit…or both?

Aggregation of saleable drug packages to shipping cases and pallets is not required by the US Drug Supply Chain Security Act (DSCSA) or the EU Falsified Medicines Directive (FMD) or the related Delegated Regulation (EUDR).  But certain business processes in the EU under the FMD will be difficult to accomplish without it, and after November 2023, the operation of the supply chain in the US will not be efficient without it (see “Aggregation: The Achilles’ Heel of Pharma Supply Chain Operation Under A Serialization Regulation”, “EU FMD: Aggregation Is Not Mandated, But It Will Be Necessary” and “Pharma Aggregation: How Companies Are Achieving Perfection Today”).  Absent a mandate, companies need to recognize, themselves, just how vital aggregation is to their businesses and prepare to generate it and/or make use of it.

Continue reading An Aggregation ‘Discussion’ →
Expiry

Global Differences In Expiration Date Encoding

Last week the European Medicines Verification Organisation (EMVO) sent a letter to all of their “Onboarding Partners” (OBPs), or drug marketing authorisation holders (MAHs) informing them of a problem EMVO is seeing with many of the expiration dates on drugs being uploaded.  The problem they highlighted in the letter has been recognized by people around the world, and each country has decided to handle it slightly differently.  Drug manufacturers should be aware of these differences to ensure compliance and avoid false failed verifications.  Let’s take a closer look at the issue and what each country expects you to do about it.

Continue reading Global Differences In Expiration Date Encoding →
DSCSA, EDDS, Interoperability, PDSA

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”. 

Continue reading PDSA’s Proposal for Governance of DSCSA Phase II Interoperability →
DSCSA, EDDS

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 →
DSCSA

DSCSA: What Wholesalers Want

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 →
DSCSA, Interoperability

DSCSA: Interoperable Data Exchange In 2023

1 Comment

Lots of people have been talking lately about what interoperable data exchange in the US pharma supply chain will look like after the Enhance Drug Distribution Security (EDDS) phase of the Drug Supply Chain Security Act (DSCSA) takes effect in November 2023 (see “Does Interoperability Change In 2023?”, “5 Myths About The DSCSA In 2023” and “Interoperability And The DSCSA”). 

Increasingly, I’ve heard the opinion expressed that there will surely be multiple approaches adopted for exchanging data, and so it will be necessary for all of those approaches to be made interoperable with each other.  Proponents of this idea claim it is unrealistic to expect a single approach to be accepted by all companies in the supply chain and therefore, having to deal with multiple approaches is inevitable.  This kind of talk makes me nervous.  Here’s why.

Continue reading DSCSA: Interoperable Data Exchange In 2023 →
DSCSA

FDA Hammer Comes Down On McKesson For DSCSA Violations

The internet lit up last week on the publication of an official warning letter from Alonza Cruse, Director, Office of Pharmaceutical Quality Operations, Office of Regulatory Affairs, to John H. Hammergren, CEO of McKesson Corporation, for violations of the Drug Supply Chain Security Act (DSCSA).  I’ve written about this situation before, back when the original FDA 483, notice of “inspectional observations”, was originally published (see “McKesson’s DSCSA 483 Explained”), but this new letter provides many more details of the incidents that led to that original notice, including some details of McKesson’s follow-up communications regarding the situation. 

Continue reading FDA Hammer Comes Down On McKesson For DSCSA Violations →