Tag Archives: Pharma Supply Chain

DSCSA Uniqueness: SNI vs SGTIN

In case you didn’t see my note at the end of my essay a few weeks ago, I am publishing new, free-to-everyone, RxTrace essays, one per month, on the Center For Supply Chain Studies (C4SCS) community website under the “Tune In | Monthly Slice of RxTrace” heading.  In fact, there are now two new essays there.  I’m finding that they are getting little notice there, so I have decided to post short intro essays, like this one, here on RxTrace.com whenever I post a new essay on the C4SCS website.  That way everyone here will get notified and can easily find them with a single click.

October’s essay is quite good.  It discusses the differences between the SGTIN that drug manufacturers put on their packages and the SNI that the DSCSA requires them to put there, and the implications of those differences.  It’s a very timely topic, I think you’ll agree. Continue reading DSCSA Uniqueness: SNI vs SGTIN

2018 HDA Traceability Seminar Recap

Dr. Ilisa Bernstein, PharmD, JD

I look forward to the Healthcare Distribution Alliance (HDA) Traceability Seminar every year because it is where the a very large number of the key members of the US supply chain meet to discuss implementation of the Drug Supply Chain Security Act (DSCSA).  Organizations like the HDA, GS1 US and the FDA often save up their significant news and publications throughout the fall so they can release them with big fanfare at this event.  This year was no exception.  All three of those organizations made news with their announcements this year. Continue reading 2018 HDA Traceability Seminar Recap

FDA’s Late Recommendation On Human Readable

Just ten weeks before the Drug Supply Chain Security Act (DSCSA) requires drug manufacturers to begin applying a serialized product identifier in barcode and human readable form to drug packages and homogeneous cases, the FDA has recommended a human readable format that differs from what the majority of  manufacturers have already chosen.  What’s going on here?  What options do manufacturers have? Continue reading FDA’s Late Recommendation On Human Readable

Does the DSCSA Have A ‘Spirit’

I was on an industry call a few weeks ago when someone from a technology vendor suggested that the industry should take some particular action because, it was aligned with “the spirit of the Drug Supply Chain Security Act (DSCSA)”.  That got me to thinking… Continue reading Does the DSCSA Have A ‘Spirit’

EMVO Admits, ‘Insufficient Randomisation’ Warnings Can Be Ignored

The EU Delegated Regulation (EUDR) of the Falsified Medicines Directive (FMD) mandates that all serial numbers placed on non-exempt drugs entering the EU supply chain after February 9, 2019 must be ‘sufficiently randomised’.  What is sufficient randomisation?  The regulation says one thing, and the European Medicines Verification Organization (EMVO), the operator of the EU Hub, says something beyond that.  What should drug manufacturers do?  The EMVO recently updated their messaging.  Let’s take another look at this important topic. Continue reading EMVO Admits, ‘Insufficient Randomisation’ Warnings Can Be Ignored

DSCSA Makes M&A More Complex/Risky/Costly

When companies are thinking about merging or acquiring (M&A) other companies, or product lines from other companies, they typically engage in a process known as “due diligence” to discover any hidden risks that might come along with the action.  In the pharma industry the risks are huge, so this activity is intense and costly.  Discovery of larger risks than expected can result in the abandonment of the M&A plan, or can result in the adjustment of the price—usually downward.  Now that pharma supply chain companies in the US are required to retain detailed transaction information about every purchase and sale of prescription drugs for six years, and must respond to verification requests over the life of the product, due diligence is now more complex and risky, and so it is more important than ever. Continue reading DSCSA Makes M&A More Complex/Risky/Costly

DSCSA: Why FDA Will Not Mandate Blockchain, EPCIS Or Any Other Specific Technology

There are a lot of discussions going on in the industry right now, over which approach and which technologies the US pharma supply chain should select to meet the 2023 requirements of the Drug Supply Chain Security Act (DSCSA).  People are understandably confused over these discussions.  Why should we guess what the FDA will accept in 2023?  Blockchain?  EPCIS?  Aren’t these debates and discussions just a waste of our time?  Why doesn’t the FDA just tell us which technology they will accept for the DSCSA in 2023?  In fact, these questions have become so common lately that I think it is time to examine what is going on.  There are definitive answers to these questions, and they are contained within the DSCSA itself. Continue reading DSCSA: Why FDA Will Not Mandate Blockchain, EPCIS Or Any Other Specific Technology

An Open Letter To Blockchain Vendors: Please Pay More Attention

Dear Blockchain Vendors,

It was good to see all of you at last week’s Drug Supply Chain Security Act (DSCSA) and Blockchain proof of concepts pilots review held by the Center For Supply Chain Studies (C4SCS) in Rockville, MD.  I hope your travel home was uneventful.  Let me say right at the top, I was in the audience representing Systech International.  My co-worker, Joe Lipari partnered with Dwight deVere of RxTransparent as the Green Team.  RxTrace is independent of Systech International.  That said, as the author of RxTrace, I have some helpful advice for you. Continue reading An Open Letter To Blockchain Vendors: Please Pay More Attention