Category Archives: 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

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

HDA Urges FDA To Withdraw Draft Guidance ‘In Its Entirety’

In a lengthy comment submission to the FDA’s recent publication of draft guidance on Standardization of Data & Documentation Practices for Product Tracing (see “DSCSA Guidance: Standardization of Data & Documentation Practices for Product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’

FDA Draft Guidance: How To Apply For A Waiver, Exception or Exemption

Last week the FDA finally published their draft guidance for submitting a waiver, exception or exemption from certain Drug Supply Chain Security Act (DSCSA) requirements.  Originally, the latest possible date FDA could delay publishing this particular guidance was May 31, 2017.  That is, 180 days before the manufacturer’s serialization and verification requirement was due to go into effect on November 27, 2017.  Once that date passed without publishing this draft, they were forced to delay the start of the serialization/verification deadline, as they did in late June last year (see “FDA Tea Leaves: Are They About To Delay The November Deadline?” and “FDA Delays Enforcement of DSCSA November Deadline: What It Means”).  That bought the FDA another year to publish, with the new publication deadline for the guidance being May 31, 2018, which they have now met (see “FDA To Publish Key Draft Guidance Tomorrow”). Continue reading FDA Draft Guidance: How To Apply For A Waiver, Exception or Exemption

FDA To Publish Key Draft Guidance Tomorrow

This morning the FDA announced their intention to publish the long overdue draft guidance on Drug Supply Chain Security Act waivers, exceptions and exemptions tomorrow.  The timing of the publication of this particular draft guidance is critical to the FDA holding their current enforcement deadline for serialization and verification for manufacturers and repackagers.  In fact, if they had failed to meet their late May deadline for publication of this particular draft guidance Continue reading FDA To Publish Key Draft Guidance Tomorrow

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

HDA Urges FDA…Please Re-Read The DSCSA

Late last month the Healthcare Distribution Alliance (HDA) submitted a letter to the FDA in response to the docket for the DSCSA Public Meeting held on February 28, 2018 (see “FDA DSCSA Public Meeting #3: A Difference?”).  Like everyone who attends these meetings, HDA appreciates the FDA holding them.  HDA recognizes the importance of clear and well-reasoned responses to every important discrepancy in interpretation their members heard during these meetings.  You can tell from this and all previous HDA letters to the FDA regarding the Drug Supply Chain Security Act (DSCSA).  This letter is another masterpiece, following previous HDA masterpieces (see “HDA Schools FDA On DSCSA” and “HDA Questions FDA’s Authority To Mandate A Centralized System For the EDDS”).

HDA’s letter about the third FDA DSCSA Public Meeting was a very effective deconstruction of eight of the ten items in FDA’s list of “Enhanced Security Needs” summarized Continue reading HDA Urges FDA…Please Re-Read The DSCSA

I Receive My First Serialized Drug From My Pharmacy: Is It Right?

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Normally drugs dispensed by American pharmacies are repackaged into the “standard” amber vial.  The pharmacy places their own label on that bottle so the patient normally doesn’t receive the manufacturer’s package that would have the new 2D barcode mandated by the Drug Supply Chain Security Act (DSCSA).  There are a few drugs that are not repackaged by US pharmacies, like most things in an inhaler and drugs in “compliance packaging” like birth control pills.  But even then, the pharmacy puts their label on the package

 

somewhere.

One of the few drugs I take daily is a statin, which has always been put into an amber bottle by my pharmacy.  A few months ago I received a three months supply, and to my surprise, the pharmacy dispensed the prescription in the manufacturer’s original 90-count bottle, and there was the DSCSA 2D barcode on the label.  The pharmacy label was positioned so that it formed a “flag” and did not cover the 2D barcode, and the pharmacy label was easily removed to expose the entire manufacturer’s label.  This drug was made by Lupin Pharmaceuticals, a generic drug manufacturer base in India.  How did they do? Continue reading I Receive My First Serialized Drug From My Pharmacy: Is It Right?