The Enhanced Drug Distribution Security (EDDS) phase of the Drug Supply Chain Security Act (DSCSA) is due to begin on November 27, 2023. That’s the first day that the US pharma supply chain is supposed to fully operate with serial numbers. Yes, serial numbers in human readable and encoded into 2D barcodes will be on every drug packaged after November of this year, but there is only limited use of those serial numbers in the supply chain until 2023. But when the EDDS starts, everything changes. From that point on, every Transaction Information (TI) document must include the full DSCSA Unique Identifiers—including the serial numbers for the first time—that are physically included in the shipment, the Transaction History (TH) no longer needs to be exchanged, and the data exchange requirements change. Let’s focus in on those data exchange changes. Continue reading EDDS: The New Data Exchange Requirements
Tag Archives: Pharma Supply Chain
2018: The Year of FDA DSCSA Public Meetings
Happy New Year, 2018 is here! Last year, the FDA announced a series of three Drug Supply Chain Security Act (DSCSA) Public Meetings (see “FDA Announces New DSCSA Pilot Program and Public Meeting Series”). So far they have held two (see “FDA DSCSA Public Meeting #1 Exposes Gulf In Goals” and “FDA DSCSA Public Meeting #2, Still A Gulf”). One more is left in that series, to be held on February 28, 2018. Continue reading 2018: The Year of FDA DSCSA Public Meetings
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
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.
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
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
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
Sponsored: Don’t Miss These Back-To-Back Pharma Serialization and Tracing Events
There is a rare alignment of events that will happen in the first week of December that is so special that you need to put it on your calendar. There are two important pharma serialization events that will occur in the Washington DC area and anyone with a serious interest in that subject should attend both. These events line up perfectly to allow you to travel once, and spend four days that will solidify your understanding of the issues and opportunities embedded within the Drug Supply Chain Security Act (DSCSA) in particular, and pharma serialization in general. Continue reading Sponsored: Don’t Miss These Back-To-Back Pharma Serialization and Tracing Events
