Tag Archives: free

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

Sponsored: FDA Speaks About DSCSA At HDA

Ilisa Bernstein, Pharm.D., J.D., FDA

Last week, Dr. Ilisa Bernstein, Deputy Director, Office of Compliance, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, spoke last week at the Healthcare Distribution Alliance (HDA) Traceability Seminar (see “HDA Traceability Seminar: RxTrace Future Topic List Explodes“).  Her presentation went beyond the simple, tight-lipped, high-level review of the Drug Supply Chain Security Act (DSCSA) that is typical of recent FDA presentations at conferences.  It was a refreshing change.

Continue reading Sponsored: FDA Speaks About DSCSA At HDA

What The TraceLink v HDA Lawsuit Teaches Us About The Value of Supply Chain Master Data

Buried deep inside the complaint filed in federal court last month by TraceLink against the Healthcare Distribution Alliance (HDA) is the heart of the issue (see “Tracelink vs. HDA”).  It’s about the sharing of product master data throughout the supply chain—that is, “Supply Chain Master Data” (SCMD) (see “Supply Chain Data Synchronization and Patient Safety”).  According to TraceLink’s complaint, the closed nature of HDA’s Origin master data sharing service (see “Dawn of HDA’s Origin, The Key to DSCSA Compliance”) is causing problems for vendors of DSCSA compliance solutions, and that will cause end-user companies in the supply chain to pay more for their overall solution. Continue reading What The TraceLink v HDA Lawsuit Teaches Us About The Value of Supply Chain Master Data

The Fall Global GS1 Healthcare Conference

On October 17 – 19, 2017 the global GS1 Healthcare community came together for their fall conference in Chicago, IL.  The conference was packed with practical information for implementing GS1 Standards across every spectrum of the Healthcare industry.  To cover the entire event, I’ve asked Karen Fleshman, Co-founder, COO of the Haskins Advisory Group, to cover the medical device sessions while I cover the pharma sessions.  Let’s hear from Karen first. Continue reading The Fall Global GS1 Healthcare Conference

Sponsored: Bio/Pharma Serialization and Traceability Summit 2017

Back on June 30, 2017, the U.S. FDA extended the product identifier requirements under the Drug Supply Chain Security Act (DSCSA) to November 26, 2018 due to insufficient industry readiness.  This gives the industry an extra full year to make sure their solutions are fully integrated and tested.  Are you ready?  Are you done?  Even those who would have been ready this November are likely to have more to do to make sure their start-ups go smoothly.  What about your European Falsified Medicines Directive (FMD) strategy?  That’s right around the corner too. Continue reading Sponsored: Bio/Pharma Serialization and Traceability Summit 2017

Sponsored: FDA DSCSA Public Meeting Q&A

The two days after the next FDA DSCSA Public Meeting, IQPC will hold their Pharmaceutical Traceability Forum | Interactive event in Washington DC.  The FDA meeting will be on December 5 and 6, and the IQPC event will be on December 7 and 8.  Perfect for attending two vitally important meetings, and only having to travel once.  The Pharmaceutical Traceability Forum | Interactive event includes a slate of excellent speakers who will provide you with their immediate impressions of the FDA meeting that will have just occurred, and the one that was held back in August (see “FDA DSCSA Public Meeting #1 Exposes Gulf In Goals”). Continue reading Sponsored: FDA DSCSA Public Meeting Q&A

HDA Schools FDA On DSCSA

Last week the Healthcare Distribution Alliance (HDA) submitted nine pages of comments in response to the FDA’s Request For Comments in docket number FDA-2017-N-3857 (find their submission here).  It is worthwhile for you to read because the HDA generally sets the gold standard for detailed analysis of the Drug Supply Chain Security Act (DSCSA), and because this one is particularly pertinent to discussions going on at the FDA and around the industry right now. Continue reading HDA Schools FDA On DSCSA

OPEN-SCS Announces Major Milestone

Today, the Open Serialization Communication Standard (OPEN-SCS) Group, a collection of healthcare sector companies dedicated to standardizing packaging line serialization and aggregation data exchanges, will announce a major milestone in the push to streamline global track & trace processes.  At Pack Expo in Las Vegas, the organization will hold a press conference to formally introduce its initial Serialization Standard, the Packaging Serialization Specification (PSS) 1.0.  The achievement is to be revealed in Continue reading OPEN-SCS Announces Major Milestone