Tag Archives: EPCIS

GS1 Healthcare US

GS1 Healthcare US Publishes Updated Guidance For DSCSA

GS1 HcUS ImplGuide 1.1I happened to be chatting with Bob Celeste of GS1 Healthcare US yesterday at the LogiPharma conference in Princeton, NJ where he was about to speak, when he found out that version 1.1 of their guideline had just been published on their website.  The full title of the 137 page document is “IMPLEMENTATION GUIDELINE, Applying GS1 Standards to U.S. Pharmaceutical Supply Chain Business Processes FOR THE DRUG SUPPLY CHAIN SECURITY ACT AND TRACEABILITY R1.1 — SEP 12, 2014”.  You can download a free copy from their web page.

I will have more to say about this document in a few weeks when I have time to review it more fully, but this is the long awaited update that brings the earlier version up-to-date with the Drug Supply Chain Security Act (DSCSA).  The 1.0 version of the guideline, published in March of last year, was Continue reading GS1 Healthcare US Publishes Updated Guidance For DSCSA →

Record-keeping

DSCSA: A Closer Look At The Six-Year Record-Keeping Requirement

??????????The Drug Supply Chain Security Act (DSCSA) contains record-keeping requirements for drug manufacturers, wholesale distributors, repackagers and dispensers that begin on January 1st.  All companies must keep a copy of the Transaction Information (TI), Transaction History (TH), and Transaction Statements (TS) they receive and those they send for at least six years.  In addition, manufacturers and repackagers must also retain knowledge about the “product identifier” on each unit they sell into the supply chain for a period of six years after the date it was sold.  Companies who perform investigations into suspect product must also keep records of their process and the outcome for six years.

There are a few implications of these record-keeping requirements.  Let’s take a look at some of them.  Continue reading DSCSA: A Closer Look At The Six-Year Record-Keeping Requirement →

Aggregation, Product Identifier Authentication

The Aggregation Hoax and PIA

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????????Pharmaceutical manufacturers should be aware that there is a lot of uninformed misinformation going around out there lately about the need for them to supply aggregation data to their trading partners to meet the Drug Supply Chain Security Act (DSCSA) (for more on aggregation, see “Pharma Aggregation: How Companies Are Achieving Perfection Today”, “DQSA: Will U.S. Pharma Distributors Mandate Aggregation Data In Phase 1?”, and “Does The DQSA Require Manufacturers To Provide Aggregation Data? Survey Says…”).  In my view, prior to 2023 you can collect aggregation data if you want to, but don’t let anyone tell you that the DSCSA requires you to.  It doesn’t.  And I also encourage you to be skeptical of any claims that wholesale distributors will not accept your product anytime soon unless you provide them with aggregation data.  Feel free to Continue reading The Aggregation Hoax and PIA →

DSCSA

U.S. Pharma Supply Chain Complexity–Revisited

© Copyright 2011 Duncan Champney. used with Permission. This image was created with FractalWorks, a high performance fractal renderer for Macintosh computers. FractalWorks is available on the Mac App Store.
© Copyright 2011 Duncan Champney. used with Permission. This image was created with FractalWorks, a high performance fractal renderer for Macintosh computers. FractalWorks is available on the Mac App Store.

About 3 years ago I published an essay called “U.S. Pharma Supply Chain Complexity” where I attempted to provide a more realistic understanding of the U.S. pharma supply chain than the typical supply chain drawing offers.  That essay was aimed at helping the industry select an approach to meeting U.S. state pedigree laws, which are now preempted by the Drug Supply Chain Security Act (DSCSA).  But, as with many of my older essays, the underlying ideas still have value despite preemption.

In this case, the ideas also provide a clear explanation for why pharma manufacturers should expect to meet the electronic data exchange requirements that are dictated by the large U.S. wholesale distributors, rather than attempting to get them to accept some alternate approach.

So I have copied and pasted that essay below and then edited to serve this new purpose. Continue reading U.S. Pharma Supply Chain Complexity–Revisited →

GS1

GS1 Ratifies Updated Versions of EPCIS and CBV

GS1_logoGS1 just updated their website with the newly updated versions of their Electronic Product Code Information Services (EPCIS) and Core Business Vocabulary (CBV) which were ratified by the GS1 Board on Monday.  Both carry the new version number “1.1”.  The two standards are separate but intertwined because the core business vocabulary is used within the various EPCIS events, so the two standards are likely to always be updated at the same time, as in this case.

This update marks the culmination of several years worth of hard work by the team, co-chaired by Michele Southall of GS1 US and Andrew Kennedy of FoodLogiQ, facilitated by the great Gena Morgan of GS1 US and with Ken Traub serving as the Editor for both standards documents, under the GS1 Global Standards Management Process (GSMP).

WHY THIS IS SIGNIFICANT FOR THE PHARMA SUPPLY CHAIN

This is a significant event for pharma supply chains around the world, but particularly for Continue reading GS1 Ratifies Updated Versions of EPCIS and CBV →

Randomization

Randomization—An Interview with Ken Traub—Part 5: Other Approaches

???????????????????This is the last of a five part interview with Ken Traub, GS1 standards expert and independent consultant, on GS1 serial number randomization.  The full series includes essays covering:

  1. GS1 Serial Number Considerations
  2. Properties of Randomization
  3. Threat Analysis
  4. Algorithmic Approach
  5. Other Approaches to Randomization (this essay)

This week Ken talks about other approaches to serial number randomization.  – Dirk. Continue reading Randomization—An Interview with Ken Traub—Part 5: Other Approaches →

Randomization

Randomization—An Interview with Ken Traub—Part 1: GS1 Serial Number Considerations

Ken Traub
Ken Traub

Over the next two weeks I have a very special treat for RxTrace readers.  It is an interview with Ken Traub, GS1 standards expert and independent consultant.  The subject is GS1 serial number randomization, something so important that I think pharma companies ought to give deep thought to it before they turn on their serial number applications.

Pharma manufacturer who sell into the E.U. and/or Brazil markets will be forced to randomize their serial numbers because of regulatory requirements, but even those who only sell into the U.S. market should strongly consider randomization.  I’ll have more to say about why in a follow-up essay after this series is over.

Because the interview with Ken covers the topic so thoroughly, it is long.  That’s good, because it provides readers with an easy to understand explanation of everything they need to know about randomizing.  But it also makes for a very long essay, so I have broken the interview down into five RxTrace essays.  Read sequentially, they contain the complete interview.  The subtopics covered by those essays include: Continue reading Randomization—An Interview with Ken Traub—Part 1: GS1 Serial Number Considerations →

DQSA of 2013

DQSA: How Should Transaction Data Be Exchanged?

FDALogoThe U.S. FDA just published a docket asking for public input into standards for the interoperable exchange of information for tracing of human, finished, prescription drugs in paper or electronic format.  Ironically, they will accept responses to the docket in either paper or electronic format.  Comments should be submitted to the FDA within 60 days.  If my calculation is correct, you have until April 21st to submit your comments.

This docket was expected because the Drug Supply Chain Security Act (DSCSA), enacted last November, gives the FDA one year to publish a draft guidance document that establishes standards for the interoperable exchange of that type of information, and they are required to consult with the industry and other interested parties [see Section 582(a)(2)].  I have written about this requirement and the short time after the guidance is published before the members of the supply chain must make use of those standards (see “The Flaw That Must Be Addressed in H.R. 3204, The Drug Quality and Security Act” and “DQSA: Getting To Electronic Transaction Data Exchange“).  This docket fulfills the first of many mandates that the FDA is facing in

Continue reading DQSA: How Should Transaction Data Be Exchanged? →