I have now read the FDA’s new draft Grandfathering Policy that was published on Monday (see “FDA Publishes DSCSA Grandfathering Guidance Exactly 2 Years Late”) and for the life of me, I can’t figure out why it took two extra years beyond the due date to get it out. Back in September of 2015 I posted an essay that analyzed the options they had in front of them (see “Will Manufacturers Be Able To Grandfather Products In Their DC And 3PL?”). All they really had to do was chose from a short list of events that could trigger the drug’s transition into the pharmaceutical distribution supply chain at the time of the effective date. They had the following options: Continue reading FDA’s New DSCSA Grandfathering Guidance
Today is November 27, 2017, the four year anniversary of President Obama signing the Drug Quality and Security Act (DQSA) into law (see “It’s Official, President Obama Signs H.R. 3204, DQSA, Into Law”), and it is the two year anniversary of the due date for the FDA to publish four guidance documents—one of the four on grandfathering (see “FDA DSCSA Deadline Passes Quietly”). And today they have finally met that requirement, for grandfathering at least. One overdue Drug Supply Chain Security Act (DSCSA) guidance down, three to go (see “Who Is Being Harmed By Four Overdue FDA DSCSA Guidances?”, “Is The FDA Intentionally Delaying Publication Of The Overdue DSCSA Guidance?“, and “DSCSA Serialization Delay Eclipses Grandfathering”). (The DSCSA is Part 2 of the DQSA.) Continue reading FDA Publishes DSCSA Grandfathering Guidance Exactly 2 Years Late
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
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.
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
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