HDA’s 2017 Manufacturer Serialization Readiness Survey Results

There is a reason so many RxTrace essays have something to do with the Healthcare Distribution Alliance (HDA) (I won’t list them all, but here are two recent ones:  “HDA Traceability Seminar: RxTrace Future Topic List Explodes” and “HDA Schools FDA On DSCSA”).  It’s because they have their fingers in just about everything related to the US pharma supply chain’s preparation for compliance with the Drug Supply Chain Security Act (DSCSA).  HDA members are literally in the “center” of the supply chain, and the organization is at the center of many of the most important initiatives related to meeting the DSCSA, including their Origin master data sharing service (see “Dawn of HDA’s Origin, The Key to DSCSA Compliance”), their future Verification Router Service (VRS) (see “First Meeting of the HDA Verification Router Service Task Force”), and they hold the most important DSCSA conference every year (see “FDA Speaks About DSCSA At HDA”).  And their HDA Research Foundation now conducts the most important manufacturer DSCSA serialization readiness survey.  They just published the latest one.  Let’s take a look at it. Continue reading HDA’s 2017 Manufacturer Serialization Readiness Survey Results

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

HDA Traceability Seminar: RxTrace Future Topic List Explodes

The 2017 Healthcare Distribution Alliance (HDA) Traceability Seminar is now in our rearview mirror.  We’ll have to wait another full year for the next one.  As usual, this year was filled with the most pertinent presentations and conversations for those interested in serialization and traceability in the US pharma supply chain—particularly in meeting the Drug Supply Chain Security Act (DSCSA).  I use events like this to discover really great new topics that need to be covered in RxTrace in the future, and this year, this event (including the IEEE Blockchain pre-event) resulted in an explosion.  That is, an explosion in the number of good topics to cover. Continue reading HDA Traceability Seminar: RxTrace Future Topic List Explodes

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