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
What a surprise it was to learn yesterday from Phil Taylor of SecuringIndustry that Tracelink, a traceability software vendor, has filed a lawsuit against the Healthcare Distribution Alliance (HDA), a non-profit industry organization representing the larger wholesale distributors in the United States (see SecuringIndustry, “TraceLink sues HDA over control of pharma track-and-trace data”). I had to check the calendar to see if it was April 1st.
It wasn’t. Continue reading Tracelink vs. HDA
The Drug Supply Chain Security Act (DSCSA) makes it clear that the FDA must work with industry stakeholders to figure out exactly how the US pharma supply chain should meet its requirements after November 27, 2023–see DSCSA Section 582(g). That section specifies “The transaction information and the transaction statements shall be exchanged in a secure, interoperable, electronic manner…”. There is no mention of the creation of an independent third-party to design or coordinate that exchange, and Continue reading A US Medicines Verification Organization (USMVO)?
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
Recently, several of the larger U.S. wholesale distributors have sent letters to their suppliers to review what they expect from them relative to the Drug Supply Chain Security Act (DSCSA). You may recall that these companies have provided requirements in advance of earlier DSCSA deadlines (see “U.S. Drug Wholesale Distributors Provide Direction To Manufacturers“). These expectations are aimed at the November 27, 2017 serialization requirements and beyond. Continue reading DSCSA Serialization: What Wholesalers Expect