Yearly Archives: 2016

GLN

GLN: The Lowly Identifier That Could Kill The Use Of EPCIS For Pharma Regulatory Compliance

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iStock_000085320577_SmallerAlmost everyone agrees that GS1’s Electronic Product Code Information Services (EPCIS) standard will be used by drug manufacturers and the large wholesale distributors in the United States for compliance with the serialization requirement of the Drug Supply Chain Security Act (DSCSA).  Even I think that (see “Will EPCIS Event Exchange Replace EDI ASNs for DSCSA Someday?”).  But there is a problem that could kill its use beyond the internal uses of today, keeping it from being used for data exchange or the data repositories that will eventually become the way data is “exchanged” in 2023 as part of the Enhanced Drug Distribution Security (EDDS) phase of the DSCSA.

The problem is, EPCIS defaults to the use of a single location identifier, the GS1 Global Location Number (GLN).  So what?  Why is that a problem?  Let me explain. Continue reading GLN: The Lowly Identifier That Could Kill The Use Of EPCIS For Pharma Regulatory Compliance →

EPCIS

InBrief: Pharma Supply Chain Leaders, Stop Throwing Interoperability Under The Bus

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57558052_smallerDuring the report out and follow-up discussion at last week’s FDA Drug Supply Chain Security Act (DSCSA) Pilots Workgroup (see “The 2016 FDA Pilots Workshop”) I heard an example of the industry throwing interoperability under the bus.  That is, setting us all up for major complications down the road that could easily be avoided if the leaders would just address interoperability right today.  One of the long-time leaders of the use of serialization and traceability in the U.S. pharma industry spoke up in front of the entire assembly and said that there existed a general “agreement” within the industry that “not everyone will use EPCIS”.  That is, not everyone will use GS1’s Electronic Product Code Information Services (EPCIS) standard for meeting the DSCSA, and consequently, the FDA and the industry will need to allow other formats of the data in 2023.  I just about fell out of my chair. Continue reading InBrief: Pharma Supply Chain Leaders, Stop Throwing Interoperability Under The Bus →

FDA Workshop

The 2016 FDA Pilots Workshop

2016-04-05 14.11.09.reducedI was initially disappointed in the FDA Drug Supply Chain Security Act (DSCSA) Pilots Workshop that was held at FDA headquarters last week, but in the end, the outcome appeared to fit the need.  Going in, I knew not to expect the FDA to convey any information to the attendees, so that is not why I was disappointed.  I attended the public DSCSA workshop they held back in May of 2014 so I already knew their typical approach for workshops like these (see “The 2014 FDA DSCSA Workshop”).  I knew that the purpose of the workshop was to inform the FDA, not to inform the attendees.  I would estimate that about one out of every four attendees were expecting the opposite, and I would bet a significant percentage of those had not even read the DSCSA once.  But that’s not why I was disappointed.

I was initially disappointed because Continue reading The 2016 FDA Pilots Workshop →

NDC

An Open Letter To The FDA, RE: Please Fix The National Drug Code Soon

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Dear FriendDear FDA,

Thanks for inviting me to your DSCSA Pilot Party this week.  I look forward to visiting you at your Silver Spring home so we can catch up on what’s been happing in our lives recently.  I’m glad you are thinking more about the Drug Supply Chain Security Act (DSCSA) lately.  I am too.

In fact, I’ve been thinking about how nice it would be if you would fix the broken National Drug Code (NDC) as part of the implementation of the DSCSA.  It’s really not very hard to do.  You already laid out and tested the path that needs to be followed when you implemented the Unique Device Identification (UDI) numbering system for medical devices a few years ago.

Remember how happy that made me?  Remember, I called it “revolutionary” (see “FDA Proposed UDI: A Revolution In Number Assignment”), and it was!  But before I get to how you could do it for pharmaceuticals, let me explain why you should do it as clearly as I can. Continue reading An Open Letter To The FDA, RE: Please Fix The National Drug Code Soon →

Conferences, serialization

Sponsored: Tracking Serialization: 2016 Pharma Trace Market Trends

Tracking Serialization titleDo you know what situation your peers’ businesses are in, and what they’re working to?  To find out just that, IQPC polled their network of pharmaceutical serialization professionals and got responses from representatives of over 20 companies.

The results?  Most find data storage and management to be their biggest issue, citing ERP systems as some of their biggest investments in 2016 and going forward.  It follows that over 50% of those we polled are either implementing their strategies in multiple sites or already done and thinking beyond compliance.

IQPC also asked about their biggest inhibitors, their current and future budgets, and their experience with international compliance.  If you want to find out what your peers think about these topics, you can download the survey report, or meet them on-site at the Pharmaceutical Traceability Forum, May 23 – 25 in Philadelphia.  Use the discount code PT_RXTRACE to get 20% off the standard price! Continue reading Sponsored: Tracking Serialization: 2016 Pharma Trace Market Trends →

EU FMD

EU FMD: Aggregation Is Not Mandated, But It Will Be Necessary

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iStock_000016455220_SmallerEver since the E.U. Falsified Medicines Directive (FMD) was passed in 2011 my European friends have touted the fact that their government mandated solution would take a “bookend” approach.  The implication was always that it would be much less complex than the ePedigree approaches that were being planned by various U.S. states, and then by the U.S. federal government with the passage in 2013 of the Drug Supply Chain Security Act (DSCSA).

My friends always liked to point out how simple Continue reading EU FMD: Aggregation Is Not Mandated, But It Will Be Necessary →

RxTrace Traceability Survey

Sponsored: The 2016 RxTrace U.S. Pharma Traceability Survey, Sponsored by Frequentz, Final Report

Cover thumbnailThe final report of the 2016 RxTrace U.S. Pharma Traceability Survey, sponsored by Frequentz is now available.  Download the full free report here.  With this year’s survey we attempted to get a glimpse of the progress toward the next deadlines of the Drug Supply Chain Security Act (DSCSA) from drug manufacturers, repackagers, wholesale distributors, 3PLs and dispensers.  Each of those different types of respondents were asked a different set of questions that were pertinent to their segment and their regulatory requirements under the DSCSA.

Frequentz.logoTake a close look at the results.  They reveal that Continue reading Sponsored: The 2016 RxTrace U.S. Pharma Traceability Survey, Sponsored by Frequentz, Final Report →

DSCSA, HDMA

HDMA DMC Serves Sizzling Steak With A Small Side Of Snake Oil

iStock_000043324250_SmallerAccording to the HDMA, their Distribution Management Conference and Expo in San Antonio last week broke the attendance record at more than 500 attendees, but for the life of me, I can’t figure out why the number wasn’t double that amount.  When you compare the value you receive by attending this (or any) HDMA event with what you receive from any third-party event, well, there isn’t any comparison.  HDMA serves sizzling steak to their soggy puffed rice.  The reason is not just the quality of the speakers.  In fact, as “speakers”, they really aren’t any better at speaking than any other group of people, but it is who they are and what they know that makes the difference.  And just as important, who else is in the audience that makes these events so special.  It’s not just what is going on in the sessions, but it is who you meet and what you learn in the hallways and networking breaks between sessions.  I’ve said this before (see “Terminology: Track and Trace, and Pedigree”). Continue reading HDMA DMC Serves Sizzling Steak With A Small Side Of Snake Oil →