DSCSA Requirements Updates by the Big Three – (Cardinal – ABC – McK)

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The Grand Alliance in the picture above (World War II), known as the “Big Three”: the Soviet Union, the United States, and the United Kingdom, or their leaders Joseph Stalin, Franklin Roosevelt and Winston Churchill. In the Pharmaceutical world we know them as Amerisource Bergen, Cardinal and McKesson.

As the date for the transition to the new DSCSA requirements approaches, a lot of attention is being paid to the actions of the “Big Three” pharmaceutical companies – AmerisourceBergen ,CardinalHealth, and McKesson. These three companies have a massive amount of influence over the rest of the pharmaceutical industry, so their decisions and announcements regarding DSCSA requirements carry implications for all other companies in the industry.

Updates from AmerisourceBergen on GTIN Repository

AmerisourceBergen and CardinalHealth issued statements this past April regarding serialization requirements. In terms of GTIN repository, AmerisourceBergen says that manufacturers must use the Healthcare Distribution Alliance’s official GTIN repository to handle master data for products as well as GTINS for all products covered by the DSCSA.  The company says that the decision that was born out of an industry need to establish “one source of truth” for GTINs and their attributed data. This was done in order to stop wholesalers and manufacturers from receiving repetitive data requests.

AmerisourceBergen also commented on the future of the Advanced Ship Notice. The company says they are willing to pilot, test, and potentially cut over to EPCIS for all Transaction Information deals prior to 2023, assuming manufacturing partners can send a serialized data through EPCIS 1.2 next year.

Updates from CardinalHealth on Verification Router Service

CardinalHealth released their communication about Verification Router Service. VRS is a solution to assist manufacturers in aggregating shipment data. It is hoped that the improved ease of aggregating data will convince more manufacturers to aggregate.

CardinalHealth’s statement says that manufacturers send aggregated data along with every shipment so that identifiers for products can be internally verified. VRS has manufacturers subscribe to a third party routing service which brokers the different requests for verification, allowing manufacturers to maintain their own databases of serial numbers.

AmerisourceBergen also supports VRS as a possible solution that lets wholesalers verify product information through a secure and connected network.

Updates from McKesson 

McKesson sent out a communication about six different topics: DSCSA suppliers, the conversion of NDC to GTIN, GS1 EPCIS Events Multiple PO, GS1 EPCIS Events Single PO, Supplier Serialization Piloting, and Quick Start for HDA Bar Code.

In terms of Data Exchange via EPCIS, McKesson expects to be utilizing EPCIS 1.2 or higher. The company expects to do Unit to Case aggregation as well as Case to Pallet Aggregation with a SSCC label for the pallet. McKesson plans to handle returns verification by sending data through EPCIS or VRS.

McKesson also clarified that they would be using HDA for case labels, and using the HDA New Product From for new Rx products. In terms of GTIN, McKesson will be using the US G1 Standard.

Comparing the Big Three

Let’s take a look at what we known about the position of each of the Big Three companies.

  • EPCIS Data Exchange: McKesson will use 1.2 or higher, Amerisource will use 1.0, 1.1, and 1.2. Cardinal has not announced what EPCIS it will be using.
  • Transaction Statement/Transaction Information: McKesson will be using ASN until at least 2023, while Ameriscource will use either ASN or EPCIS 1.2. Cardinal has committed to going paperless.
  • Case to Pallet Aggregation: McKesson says it expects aggregation with pallet SSCC labels, the other two companies have not said how they will handle pallet aggregation.
  • Unit to Case Aggregation: McKesson expects to aggregate, while the other companies have not specified what they will do.
  • Returns Verification: All three companies have agreed to send data via EPCIS or Router Services.
  • Unit Label: Cardinal and Amerisource both plan to utilize GS1 and HDA, along with barcode testing.
  • Case Label: Once again, Cardinal and Amerisource both plan to utilize GS1 and HDA, along with barcode testing. However, McKesson only plans for HDA support right now.
  • GTIN embedded with NDC: McKesson and Cardinal have both agreed to use US and GS1 Standards.
  • Master Data: Amerisource has said they will make use of the HDA GTIN Repository, the other two companies have not stated their plans.
  • New Rx Products: McKesson says that HDA New Product Forms will be used for new products, while the other two companies out of the Big Three have not stated how they will handle new Rx products.
  • Expiry Date: McKesson has said it will not be using “00” dating for expiry dates. No communication from Amerisource or Cardinal on the topic yet.
  • Non-Serialized Products After 2017: Cardinal has agreed to non-serialized products after 2017 if they meet FDA criteria, while Amerisource has agreed generally. McKesson has not stated how their position on the topic.
  • Non-Serialized Products After 2019: Cardinal and Amerisource have said they will not support Non-Serialized Products After 2019, and McKesson hasn’t stated if they will or will not.

Serialization Implications

Essentially the Big Three distributors want two main things out of those grappling with the new DSCSA requirements. They want to ensure labels for all goods and products are correct and that the right serial data is sent to them. It remains to be seen how effective the EPCIS system will be when dealing with distributors, but hopefully the transition to the new requirements will occur with fewer problems now that the Big Three have clarified their positions on a few things.

One thought on “DSCSA Requirements Updates by the Big Three – (Cardinal – ABC – McK)”

  1. I am a bit confused about references to GTIN and “US GTIN”.

    A Global Trade Identification Number (GTIN) is a GS1-defined trade item identifier that, unlike the NDC, is just a number, intended to be a pointer back into EPCIS. . For the purposes of this discussion, it is a 14-digit number that contains both the vendor’s GS1 identifier and their catalog number.Vendors must purchase GS1 vendor identifiers from GS1 register GTINS with GS1.

    There is also a GS1 GTIN data encoding format within any bar code (theoretically symbology agnostic) that has a 5 lead characters, a 14-digit GTIN and a check digit (at minimum) and may be extended with additional application identifiers that can include things, like, lot, expiry date and serial number.

    01003 «GTIN»c17«exp»10«lot»«separator»21«serial number»

    01 indicates that the bar code is a GTIN bar code
    3 indicates a medication
    c = check digit
    «separator» defines the end of a variable-length entry and the start of another application identifier. It is defined as FNC1 (ASCII code 29, 0x1D). In this example it denotes the end of the lot number and the location at which the ’21’ indicates the start of the serial number.

    There is a US-specific version of this encoding that permits a 10-digit NDC to be zero-padded into the 14-digit space. It is widely used in the US, but is not the only GS1 encoding currently used (UPC-12 is also often used to display only the NDC – 3«NDC»c).

    Unlike the GTIN, the NDC is a (theoretically) “smart” number that can be parsed into three segments: the labeler code, the drug code and the packaging-level code. By definition, it is a ten-digit number.

    There is an 11-digit variant of this number that is widely used, but is not established in law or regulation. It would not appear in a bar code.

    The structure, assignment and tracking of the NDC is defined in US law and regulation.

    So… when we talk about using the GTIN, are we talking about the US abandoning the NDC and going to the use of the “real” GTIN, or are we talking about using the current shoehorning of the NDC into the GTIN data encoding format?

    As big as the “big three” are (which one of them is Stalin?), I struggle to see even the three of them combined making rapid changes to US federal law and regulation.

    Just one guy’s opinion…

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