FDA To Hold DSCSA Pilots Workshop

As we saw last fall, the FDA is planning to conduct at least one pilot project in 2016 to fulfill its DSCSA mandate to do so.  The pilot should focus on the 2023 DSCSA technologies and processes (see “FDA Looking For Consulting Org To Run DSCSA Pilots“).  Today we learned that a pilot will indeed occur this year, … Continue reading FDA To Hold DSCSA Pilots Workshop

DSCSA: Congress Should Have Mandated Randomization

Congress should have mandated randomization of drug serial numbers, but they did not, so it is up to each manufacturer to recognize the importance it would bring to the protection of their brands and of the supply chain.  Let me explain. The text of the Drug Supply Chain Security Act (DSCSA) was developed last year … Continue reading DSCSA: Congress Should Have Mandated Randomization

Product Identifier Authentication (PIA)

In my last essay I touched on the use of Product Identifier Authentication, or PIA, as an alternative to the collection and distribution of aggregation data to allow wholesale distributors and repackagers to meet the verification requirements of the Drug Supply Chain Security Act (DSCSA).  Starting in November of 2018 for repackagers and in November … Continue reading Product Identifier Authentication (PIA)

The Future of Healthcare Supply Chain Security

Let’s take a brief pause from our in-the-moment work on meeting today’s healthcare supply chain security needs and consider what the supply chain will look like in the future.  Because of regulations and laws enacted in 2012 and 2013 in the U.S., and expected in 2014 in the E.U., we know more today about how … Continue reading The Future of Healthcare Supply Chain Security

How the DQSA Will–And Won’t–Protect The Supply Chain, Part 2

Last week I published an overly long essay about how the supply chain provisions of the new U.S. Federal DQSA will and won’t protect the pharma supply chain.  Believe it or not, I had more to say on the subject, but because that essay was already too long, I withheld my additional thoughts until now.  … Continue reading How the DQSA Will–And Won’t–Protect The Supply Chain, Part 2

Sponsored: Transatlantic Alignment

Happy Martin Luther King day!  Today we have a special guest blog essay by Mark Davison of Blue Sphere Health in the U.K..   Mark is the author of the book, “Pharmaceutical Anti-Counterfeiting”, published by Wiley in 2011. – Dirk. Pharmaceutical traceability (in its various nuances of serialization, aggregation, track and trace, epedigree etc) has … Continue reading Sponsored: Transatlantic Alignment

InBrief: FDA Publishes Final UDI Rule

The FDA has finally published the long-awaited final rule on Unique Device Identification (UDI).  I was in the audience at the UDI Conference this morning when Jay Crowley of the FDA made the announcement.  Sparkling juice was distributed to the entire audience of 400+ attendees shortly after the announcement.  See “FDA finalizes new system to … Continue reading InBrief: FDA Publishes Final UDI Rule