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