Yearly Archives: 2018

DSCSA

HDA Responds To FDA Waivers, Exceptions, Exemptions Draft Guidance

Unlike the implication of this drawing, FDA does hear and care about submitted comments.

The Healthcare Distribution Alliance (HDA) recently posted their response to the latest draft Drug Supply Chain Security Act (DSCSA) guidance published by the FDA.  That draft guidance explains how, when and why companies in the US pharma supply chain can apply for waivers, exemptions and exceptions to provisions in the DSCSA (see “FDA Draft Guidance: How To Apply For A Waiver, Exception or Exemption”).  As usual, the HDA took close to the full sixty day comment period to respond.  The comment period closed last Monday. Continue reading HDA Responds To FDA Waivers, Exceptions, Exemptions Draft Guidance →

DSCSA

Newly Published Material From HDA and C4SCS

I was on vacation last week and only arrived home Sunday evening so I didn’t have time to write an essay for Monday, but this is Tuesday!  Near the end of last month there was a spike in the number of things that need to be covered in RxTrace.  Two of them are important things from HDA and the Center For Supply Chain Studies.  I’ve been waiting for both for months, and here they are. Continue reading Newly Published Material From HDA and C4SCS →

DSCSA

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

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 →

DSCSA, supply chain master data

Simple, Standard, Low Cost Product Master Data Synchronization for DSCSA

The lack of simple, standard, low cost product master data synchronization threatens to derail the industry’s general consensus-plan to use GS1’s Electronic Product Code Information Services (EPCIS) as the basis of the interoperable electronic data exchange to meet the 2023 requirements of the Drug Supply Chain Security Act (DSCSA) (see “HDA Questions FDA’s Authority To Mandate A Centralized System For the EDDS”).  This is probably why the Healthcare Distribution Alliance (HDA) tried to get out in front and offer their Origin master data synchronization service last year (see “Dawn of HDA’s Origin, The Key to DSCSA Compliance”).  And it likely underlies why TraceLink filed a lawsuit against HDA a few months later (see “Tracelink vs. HDA” and “What The TraceLink v HDA Lawsuit Teaches Us About The Value of Supply Chain Master Data”, and also see the standard disclaimer below).  That lawsuit has since been settled out of court.

Without everyone holding the identical product master data for every drug they might receive, EPCIS messages used to document DSCSA transactions will need to carry that master data.  That would induce a heavy Continue reading Simple, Standard, Low Cost Product Master Data Synchronization for DSCSA →

Blockchain

Important New Blockchain Study Launched

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Today, the Center For Supply Chain Studies (C4SCS) announced that they are launching a new study called “Blockchain & Metadata”.  C4SCS has been studying blockchain applications in the US pharma supply chain for nearly two years—including its potential use to help the industry meet future requirements of the Drug Supply Chain Security Act (DSCSA) (see “Could Blockchain Technology Be Used For DSCSA Compliance?”).  This newly announced study marks the first time the organization plans to explore applications of blockchain technology without specifically attaching them to pharma, although the subject definitely applies in pharma.  Target participants of this study include Continue reading Important New Blockchain Study Launched →

DSCSA

HDA Urges FDA To Withdraw Draft Guidance ‘In Its Entirety’

In a lengthy comment submission to the FDA’s recent publication of draft guidance on Standardization of Data & Documentation Practices for Product Tracing (see “DSCSA Guidance: Standardization of Data & Documentation Practices for Product Tracing”), the Healthcare Distribution Alliance (HDA) called on the FDA to move on and focus on requirements for deadlines in the future, not those in the past.  HDA’s comments on this guidance was the most strongly-worded submission of any they have made yet related to the Drug Supply Chain Security Act (DSCSA).

This is the first time I can remember HDA considering a draft guidance to be so bad that they called for its withdrawal in its entirety.  They are not even asking the agency to re-write it.  They feel that the guidance it contains is Continue reading HDA Urges FDA To Withdraw Draft Guidance ‘In Its Entirety’ →