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The Future Of RxTrace

RXTRACE_LOGO_Trans_300x113When I created RxTrace almost six years ago my goal was to introduce and explore new ideas and opinions I had about technology issues related to regulatory compliance within the pharmaceutical supply chain. (see my first essay that explains this purpose:  “Welcome to rxTrace”).  Hopefully my loyal readers will agree that I have accomplished exactly that, many times.  Later, when I struck out on my own as an independent consultant, RxTrace also generated leads which led to new consulting engagements.  It served to Read the rest of this essay »

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ANVISA And The SSCC Controversy

ANVISA logoGS1’s Serial Shipping Container Code, or SSCC, has been around a long time, but the logistics identifier has recently taken center-stage in a number of controversies related to meeting several country-specific pharma traceability regulations.  I’ll cover these controversies in multiple essays—in this one, Brazil.

This controversy started when ANVISA, the pharma regulator in Brazil, indicated in their regulations that they expected companies to mark every “transport package” entering their supply chain with a unique identification code so that each serialized unit inside can be associated with it (the aggregation requirement).

The problem is, a homogeneous case of product can Read the rest of this essay »

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India’s Pharma Export Regulations Update And The NECC Story

ReporterI was more than a little disappointed when I saw that SecuringIndustry.com had beaten me in a race to publish an essay/article about the new crazy serialization and traceability requirements published last week by the government of India.  That was to be my topic for next Monday.  But after reading their excellent coverage—received just as I was sitting down to begin writing—I felt better.  At least I had not yet started writing!  Don’t miss Phil Taylor’s excellent coverage and his link to the source regulation.  See if you agree how crazy it is.  The deadlines are now Read the rest of this essay »

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Thank You Ron Bone!

Bone Ron Prototype 1

Ron Bone

Well over 18 months ago I learned that Ron Bone was stepping down as SVP of Distribution Support at McKesson.  He immediately became a solo consultant and was engaged directly with McKesson again, but this time he filled a part-time role.  This was Ron’s way of staying connected with the activities at McKesson related to meeting the federal Drug Supply Chain Security Act (DSCSA) which was on its journey toward enactment, and it was McKesson’s way of maintaining continuity in those efforts.  Win-win.

Ron originally intended to fully retire last July…then December…and now, someday.  Does anyone think it will happen this time?  Frankly, I hope not.  I think Ron is having too much fun, and everyone in the industry who knows him enjoys having Ron engaged as much as he is willing.  So take your time Ron.  No need to rush.

Like Bob Celeste, who departed GS1 US last month after serving as the lead traceability facilitator and motivator for the U.S. pharma supply chain (see “Thank You Bob Celeste!”), Ron was Read the rest of this essay »

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Will EPCIS Event Exchange Replace EDI ASNs for DSCSA Someday?

SteadyState.2015.to.2023The use of Electronic Data Interchange (EDI) Advance Ship Notices (ASNs) in the U.S. pharmaceutical supply chain has expanded over the last year, due entirely to its recognition by the FDA as a valid method for passing the Transaction Information (TI)Transaction History (TH), and Transaction Statements (TS) as required by the Drug Supply Chain Security Act (DSCSA).  The Healthcare Distribution Management Association (HDMA) has encouraged that expansion by publishing a “how-to” guide for meeting the requirements of the DSCSA using an ASN (see “HDMA Has Updated Their EDI ASN Guidance For DSCSA, Again”).

Although not everything has worked out Read the rest of this essay »

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DSCSA Deadline Represents A Crossed Threshold Into The SCMD Era

iStock_000055622022_SmallerThere is a not-so-secret situation that has been festering for years in the internal IT systems of many companies in the U.S. pharma supply chain.  In the past, nobody liked to admit it, but most would, because the full extent of the problem was hidden away from public view.  It was an internal problem mostly affecting only internal systems.

The problem was that the quality of the local master data was poor.  Master data is the data that companies hold in internal databases to describe their trading partners (customers and suppliers), products (their own and those of other companies), contract parameters (pricing, authorization, terms and conditions, etc.), and facilities, etc.

Companies get lulled into thinking this data Read the rest of this essay »

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InBrief: HDMA Updates DSCSA Q&A

HDMA LogoThe Healthcare Distribution Management Association (HDMA) recently updated their “HDMA Qs and As on the Drug Supply Chain Security Act (DSCSA)” to version 2.0.  This is a very well thought through document that will help companies understand how wholesale distributors are interpreting confusing or ambiguous sections of the law.  The document leans heavily toward questions about how wholesale distributors will need to react in various situations, but it will also be a resource that manufacturers, repackagers and dispensers will want to obtain and review.  What is really needed is for someone to do the same kind of analysis for questions that mainly affect those other supply chain entities.   Read the rest of this essay »

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Progress Toward Serialization!?

2014 enough time graph.zoomLast week I announced the availability of the 2015 RxTrace U.S. Pharma Traceability Survey Results that are sponsored by Frequentz.  You should download a free copy of the report here.  This week I want to look at another interesting finding taken directly from the report.  It shows that progress is being made by drug manufacturers, repackagers and CMO/CPOs toward meeting the 2017 (2018 for repackagers) deadline for adding serial numbers to the drug packages they produce for the U.S. market.  That requirement comes from the Drug Supply Chain Security Act (DSCSA) enacted in November of 2013.

One of the many questions we asked Read the rest of this essay »

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