A few weeks ago, GS1 US published version 1.2 of the DSCSA implementation guidance that documents how to apply GS1 standards when meeting the U.S. Drug Supply Chain Security Act (DSCSA). GS1 US is the GS1 Member Organization (MO) in the United States, of GS1, the global supply chain standards organization. Companies who market drugs in the U.S. pharma supply chain and their solution providers will find this new version to be an indispensable resource that will help them meet the regulation using GS1’s various standards.
For that purpose, it is a complete reference and I highly recommend that you download a free copy, but it is not light reading. It is composed of one main volume and three addendums:
- Applying GS1 Standards for DSCSA and Traceability
- Addendum: Guidance and XML Examples for Supply Chain Choreographies in Lot-Level Management
- Addendum: Diagrams and XML Examples for Lot-Level Management Exceptions Processing
- Addendum: Diagrams and XML Examples for Serialized Exceptions Processing
On first look, the more than 650 pages across four volumes makes it appear formidable, but it’s not really that bad. Most people will only need the main volume. Implementers will need one or more of the addendums. The main volume has separate parts that deal with the use of GS1 standards for meeting the lot-based and serialization-based requirements of the DSCSA. The first two addendums deal only with lot-based compliance, and the last addendum deals only with serialization-based compliance.
THE LOT-BASED CONTENT
Part II of the main volume, “Application of EPCIS for Lot-Level Management”, was carried forward from version 1.1, although there are some important updates in this new version. It deals with lot-level management related to using GS1 standards to meet the (2015) lot-level requirements of the DSCSA. I think it’s safe to say that no one is currently using GS1’s Electronic Product Code Information Services (EPCIS) to exchange DSCSA transaction documents with their trading partners, nor should they in the future.
Back in 2014 the big wholesale distributors demanded lot-based DSCSA transaction documents be provided to them in the form of Electronic Data Exchange (EDI) Advance Ship Notices (ASNs), and so that’s what everyone is doing. There is no valid reason to change until November of 2023 when the DSCSA enters its final phase (see “Will EPCIS Event Exchange Replace EDI ASNs for DSCSA Someday?“, “U.S. Drug Wholesale Distributors Provide Direction To Manufacturers” and “HDMA DMC Serves Sizzling Steak With A Small Side Of Snake Oil“). So Part II of the main volume and the two lot-based addendums can safely be ignored.
THE SERIALIZATION-BASE CONTENT
The content in Part III of the main volume, “Application of EPCIS for Serialized Item-Level Traceability”, is new in this edition. As the name implies, it deals with the use of serial numbers to implement item-level traceability using GS1’s EPCIS. This will be necessary for everyone under the DSCSA in 2023, but for some it will be necessary as early as 2018. Drug manufacturers who intend to meet the requests (demands?) of wholesale distributors to provide them with serial number information so they can meet their 2019 saleable returns verification requirements, will need this guidance to ensure interoperability (see “HDA Delivers Home Run To Record-Breaking Audience“). While this is technically not a DSCSA regulatory requirement until 2023, it looks like it will be a DSCSA-triggered business requirement in 2018.
The addendum called “Diagrams and XML Examples for Serialized Exceptions Processing” is necessary because nothing is perfect. When companies begin documenting product shipments at the serial number level in EPCIS events, errors are going to occur. Because EPCIS would be used to comply with the DSCSA, these errors will need to be corrected, in most cases. “Exception processing” is the term used here for the processes necessary to fix the anticipated errors after November of 2023, when EPCIS events will likely be used for compliance. These will be complex processes that every company in the supply chain will need to understand and take part in.
WHO SHOULD USE THIS NEW DOCUMENT SUITE?
This new suite of documents will be indispensable for solution providers who are building applications that will be usable by members of the supply chain for meeting the DSCSA. But should end users care about the detailed information contained in them? Probably not at the level of detail contained within the addendums or even some of the more detailed sections of the main document, but Part I of the main document provides a good introduction to GS1 standards and how they can be used to meet the DSCSA. It is important that all companies in the supply chain have one or more decision-makers and technical people who understand that level of content. As time gets closer to 2023, the need to resolve errors will mean that companies will need to have a deep understanding of the concepts described in this guide.
NEW GS1 VIDEO
GS1 Healthcare has released a new viral video that demonstrates the value of their standards in a very simple, elegant and personal way. If you haven’t seen it, check it out: