Last week, GS1 US published a free DSCSA resource that every RxTrace reader must have. It’s called “Frequently Asked Questions (FAQs) by the Pharmaceutical Industry in Preparing for the U.S. DSCSA” and it can be downloaded free after registration. Do it now, then come back and finish reading this essay.
The document is 42 pages in PDF form and it contains answers to 124 frequently asked questions about using GS1 standards to meet the U.S. Drug Supply Chain Security Act (DSCSA). As the title indicates, these questions and answers were compiled by a collection of people that have most experience implementing solutions to meet the law, and people with the most knowledge of GS1 standards. Many of the authors fit into both of those categories. And it shows in the results.
You won’t find a more complete resource, from foundational background topics (example: “What is a GTIN?”) to detailed special topics (example: “What happens if the unit of measure, UOM, differs between trading partners? e.g., I refer to Carton, ‘CT’, and my trading partner calls my carton an each, ‘EA’ ”).
The document is broken down into five sections. The first three are the typical GS1 categories of “Identify”, “Capture” and “Share”, and the two additional sections are “Additional Questions”, and “Additional Resources”. Everyone will learn something by reading through, or even just skimming through it. I would describe the answers as concise but complete.
It really is a nearly perfect resource for those who need a better understanding of how to make use of GS1 standards for meeting the DSCSA. I just wish it had more hyperlinks to other resources. I believe an FAQ document should be a directory, via hyperlinks, to other, more detailed resources. I counted about 40 hyperlinks in the document, but about 30 of those 40 are to the same document: the GS1 US Implementation Guideline: Applying GS1 Standards for DSCSA and Traceability, Release 1.2.
That is an important reference, and this FAQ doc is a companion to that document, but the target audience would benefit from links to such foundational GS1 reference gems as GTIN, “Healthcare GTIN Allocation Rules”, GLN, SSCC, Datamatrix, Tag Data Standard, Tag Data Translation, the Global Traceability Standard (currently undergoing major revisions), and one of my favorites, “GS1 RFID/Barcode Interoperability Guideline”. All of these references are missing, even from the thin “Additional Resources” section. Yes, you can find those hyperlinks in the “mother” document (“…Applying GS1 Standards for DSCSA and Traceability, Release 1.2”), but some people are likely to use this FAQ document more than that one. Overall, this is a very minor problem considering the valuable answers this document contains.
Speaking of additional resources, make sure you get a copy of my book, “The Drug Supply Chain Security Act Explained”, now at a new low price on CreateSpace (an Amazon company) and Amazon.com!