A US Medicines Verification Organization (USMVO)? Again

If you’re like me, you are doing at least some work this week.  I usually do some work work during this quiet time when I am not interrupted.  It’s usually things I need to do to wrap up the year, but also includes planning for the new year.  In case you are working this week but you need a little diversion, here is something to think about for 2018.

It has become increasingly clear that what the US pharma supply chain needs is for some organization to step up and take responsibility for the decisions and actions that are needed to ensure successful development and operation of the Enhanced Drug Distribution Security phase of the Drug Supply Chain Security Act (DSCSA).  There are less than six years before that phase is supposed to begin.  But with no one clearly specified as the organization responsible, odds are, it isn’t going to happen.  This was the topic I covered two months ago when I originally published “A US Medicines Verification Organization (USMVO)?”.  With the end of the year and the holidays coming up, I’ve been too busy to write a new essay this week, so take another look at this idea. Continue reading A US Medicines Verification Organization (USMVO)? Again

European Medical Device and In Vitro Diagnostic Medical Device Regulations Conference

Author Karen Fleshman

Once again I’ve asked Karen Fleshman, co-founder and COO of Haskins Advisory Group, to step in and cover the recent EU MDR and IVDR Conference that focused on Unique Device Identification (UDI).  I’ll return after the holidays with more coverage of pharma serialization.  Thanks Karen! –Dirk.

On December 4 – 6, 2017, the European Medical Device (MDR) and In Vitro Diagnostic Medical Device (IVDR) Regulations Conference was held in Orlando, FL. The conference was designed to educate, support, and assist US based medical device manufacturers in gaining critical insight on the requirements of the European Union (EU)’s Unique Device Identification (UDI) compliance program. Continue reading European Medical Device and In Vitro Diagnostic Medical Device Regulations Conference

FDA DSCSA Public Meeting #2, Still A Gulf

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The gulf in expectations and goals exposed in the first FDA Drug Supply Chain Security Act (DSCSA) Public Meeting back in August (see “FDA DSCSA Public Meeting #1 Exposes Gulf In Goals” and “HDA Schools FDA On DSCSA”) was still visible in the second meeting last week.  There is still one more announced meeting scheduled for February 28, 2018 for the FDA and the industry to align (see “FDA Announces New DSCSA Pilot Program and Public Meeting Series”).  Based on my observations at these first two meetings, I’m not going to hold my breath.  The FDA is likely to announce more meetings in 2018.

The FDA did adjust their position on at least one thing after the August meeting. Continue reading FDA DSCSA Public Meeting #2, Still A Gulf

HDA Guidelines For Bar Coding In The Pharmaceutical Supply Chain

It has been six years since the Healthcare Distribution Alliance (HDA) updated their full barcode guidelines (see “Updated HDMA Bar Code Guidance: A Must Read”).  They just updated it again with major changes over the 2011 version.  The new document is called “HDA Guidelines For Bar Coding In The Pharmaceutical Supply Chain” and it is available on HDA’s website here.  With the passage of the Drug Supply Chain Security Act (DSCSA) in November of 2013, an update was long overdue.

You are forgiven if you thought the HDA updated the barcode guidelines only one year ago Continue reading HDA Guidelines For Bar Coding In The Pharmaceutical Supply Chain