Dawn of HDA’s Origin, The Key to DSCSA Compliance

This week at the Healthcare Distribution Alliance (HDA) Distribution Management Conference and Expo (DMC) the HDA and ValueCentric will provide much more detail around the new master data sharing service they plan to make available in July.  The new service—named “Origin”—is intended to provide members of the pharma supply chain with a single directory of master data for all prescription drugs marketed in the United States (see Origin website).  That is, it is a database of master data wrapped within a cloud-based service. 

Origin master data is composed of all attributes that are pertinent to the distribution of every packaging level of every drug.  That includes the containment relationships between the various packaging levels (units, bundles, cartons, cases, etc.) of each drug.  Each master data record stored by manufacturers in Origin must be assigned a unique 14-digit GS1 Global Trade Item Number (GTIN-14).  Each unique GTIN-14 serves as the index key for the single master data record that describes a single packaging level of a single drug product.  Only GTIN-14s issued by GS1 US may be used because they must encode the drug product’s National Drug Code (NDC) as registered with the FDA by the drug’s market authorization holder (see “Anatomy Of The National Drug Code” and “Depicting An NDC Within A GTIN”).

Origin is necessary for the smooth implementation of the Drug Supply Chain Security Act (DSCSA).  Without a single agreement among all parties in the supply chain about exactly what each GTIN used in DSCSA documentation means, smooth implementation of the DSCSA is simply not possible.  Without that agreement, the manufacturer will refer to a given GTIN in their documents, and downstream trading partners could interpret it as referring to something different.  And without a common agreement of the containment relationships between the various packaging levels, a significant number of errors will occur in the supply chain.  After November of 2019, some of those errors could result in violations of the DSCSA.  By November of 2023, when the full DSCSA Enhanced Drug Distribution Security (EDDS) becomes effective (see “5 Myths About The DSCSA In 2023”), every error will need to be investigated and corrected.  Origin will allow the industry to eliminate many of those potential errors, and will make it much easier to quickly resolve those that do occur.

As I understand it, HDA is the owner of the service and ValueCentric is the service provider under contract to implement and host the service.  If HDA had not initiated Origin, someone else would have had to do it.  But the question is, why not just use GS1’s Global Data Synchronization Network (GDSN)?  My description of Origin makes it sound a lot like GS1’s existing standardized service.  That’s because it is.  But there is one big reason why GDSN won’t work today, and that is, it doesn’t have the data elements necessary for DSCSA compliance.  Yes, it is possible to petition GS1 to add those data elements, but that takes way more time than we have.  The industry needs a service ASAP, and Origin will be it, for now.  Perhaps someday Origin itself will morph into just a GDSN data pool, but until the necessary attributes are added, it will be standalone.

Origin is just the latest action by HDA to lay the groundwork necessary for the industry to properly implement the DSCSA.  Their earlier groundbreaking work includes:

  • Barcode guidance
see “The HDA Bar Code Quick Start Guide For Meeting The DSCSA And Other FDA Regulations
  • DSCSA scenarios
see “The HDMA Supply Chain Product Transaction Scenarios For DSCSA
  • EDI guidance
see “HDMA Has Updated Their EDI ASN Guidance For DSCSA, Again
  • DSCSA Pilots
see “DSCSA: Saleable Returns Verification
  • DSCSA Q&A
see “InBrief: HDMA Updates DSCSA Q&A
  • DSCSA Survey
see “HDA’s 2016 Serialization Readiness Survey
  • Webinars
see “Important HDMA Webinar On Barcoding for DSCSA
  • Collaboration

see “HDMA DMC Serves Sizzling Steak With A Small Side Of Snake Oil” and “HDA Delivers Home Run To Record-Breaking Audience

Origin is HDA’s boldest move yet.  If your company is a member of the U.S. pharma supply chain, stay close to this development and plan to adopt it.

Dirk.

One thought on “Dawn of HDA’s Origin, The Key to DSCSA Compliance”

  1. Please allow me to offer one clarification regarding the GDSN. I have not seen the specific list of the attributes required by the HDA Origin database, however, a while back we did a comparison of DSCSA master data requirements against the GDSN and were able to confirm that the GDSN does have the data elements covered. Today’s GDSN contains approximately 1,500 attributes for the many industries, use cases and regulation it supports which includes the Pharma industry.

    Additionally, as with all GS1 standards, anyone from the industry can submit a Work Request into the GS1 Global Standards Management Process (GSMP) – http://www.gs1.org/standards-development to add attributes to the GDSN. As with any GS1 standard, there is an industry vetting and formal ratification process which can take some time. However, we recognise that the industry needs standards to support them at the speed of business, or regulation in this case, and therefore there is a formal process called Attribute Value Pair (AVP) – http://www.gs1.org/edi-xml/technical-user-guide/attribute-value-pairs-avp which makes attributes that have been approved via the GSMP available immediately.

    Lastly, we would be happy to do an analysis of the HDA Origin database attributes against the GDSN as soon as a list is available.

    Best regards,
    Pete

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