Did you feel that jolt? With the DSCSA serialization deadline just eight months away, any communication from industry heavyweights like the Big Three (McKesson, CardinalHealth, AmerisourceBergen) has the feel of breaking news.
Thus, it was a big deal that just two weeks before the Healthcare Distribution Alliance’s (HDA) Distribution Management Conference (DMC) in Palm Desert, two
leading wholesale drug distributors (WDDs) issued new letters about serialization requirements. As they did last April, Cardinal and AmerisourceBergen (ABC) made announcements a few days apart. Also like last year, the letters have some similarities and some differences. More importantly, both have guidance and requirements that are new from the last time, including concepts that are brand new to the industry.
Let’s review the letters and sort out what’s going on.
What’s New from AmerisourceBergen
The first big item from AmerisourceBergen is GTIN repository.
“Manufacturers will be required to use the HDA sponsored GTIN repository to provide product master data and GTINs for all DSCSA applicable products. The industry needed one ‘source of truth’ for GTINs and their data attributes in order to prevent repetitive data requests to manufacturers and wholesalers.”
HDA and Value Centric debuted the new GTIN repository at HDA’s DMC last week. A collaboration between HDA and Value Centric, the repository is designed to be an interim solution until GDSN develops the capabilities to manage pharmaceutical master data. The general release is planned for July 2017.
The second revelation was about the fate of the Advance Ship Notice (ASN).
“If manufacturing partners are able to send serialized data in 2018, via EPCIS 1.2, and are interested, we are willing to test, pilot, and potentially cutover to EPCIS for all TI, TS exchange earlier than 2023. We will manage this on a trading partner by trading partner basis.”
This is a departure from last year’s messages, but a welcoming one. Once trade data is exchanged in EPCIS, ASN is simply a duplicate. Being able to do without ASN is a big savings for the manufacturers. Pharma companies have enough to do given today’s demands, and having one less task is a big win for all.
CardinalHealth and AmerisouceBergen Align on Verification Router Service
It is well known that the wholesalers are big advocates of aggregation. Their messages to manufacturers and the FDA have been clear and consistent: Aggregation data is the path to verify returned products. HDA published its Manufacturer’s Readiness Survey in November 2016. The survey showed a bleak picture of the aggregation adoption rate. A full 33 percent of manufacturers don’t plan to aggregate, and 53.4 percent of manufacturers don’t think they will send aggregated shipment data starting November 2017.
To overcome this challenge, wholesalers need an alternative solution: Verification Router Service (VRS).
Cardinal’s letter reads:
“Manufacturers send aggregated serialized data with each shipment so product identifiers can be verified internally…. Verification Router Service (VRS)—manufacturers maintain their own database of serial numbers and subscribe to a third-party routing service that brokers all requests for verification and corresponding manufacturer responses.”
The 33 percent and the 53.4 percent companies can breathe a sigh of relief – it’s not the end of the world. But there are still a lot of unknowns around VRS—it’s considered a solution still in the making, with many of the finer details and future implications still too vague to read clearly.
Manufacturers who invested heavily in making aggregation as a priority should keep in mind that although aggregation is not an FDA requirement by 2017, it is an FDA requirement by 2023. Taking the initiative on aggregation allows time to learn from mistakes and improve operations.
VRS is not better or worse than aggregation. It’s simply another alternative solution that enables wholesalers and other partners in the supply chain to verify product information through a connected and secure network.
Hard Stop of None-Serialized Rx Products by 2019?
In the absence of FDA grandfathering guidance, wholesalers are unsure if they will be trading non-serialized products after 2019. AmerisourceBergen had this to say:
“We would like to address the concerns around grandfathering, specifically whether AmerisourceBergen will accept non-serialized products after November 27, 2017. Unless otherwise prohibited by FDA guidance, AmerisourceBergen intends to transact with non-serialized products until November 2019, which at that time, we are required to only transact with serialized products – by law.”
As of today, the FDA has not grandfathered, waived, or exempted anyone or any products other than what is stated in the DSCSA. Based on that, wholesalers are not taking risks. DSCSA non-compliance is a serious federal offense.
Cardinal echoes ABC’s position:
“Effective November 27, 2019, Cardinal Health will not accept DSCSA products that are not serialized.”
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About LSPediA – Life Sciences Solutions
LSPediA is a leading provider of services and solutions that secure supply chains, protect against product counterfeiting, and help businesses comply with FDA regulations. Our customers are partners in the pharmaceutical supply chain, including manufacturers, wholesale distributors, dispensers, and reverse logistics providers. LSPediA helps customers define needs and implement best-of-breed supply chain and enterprise solutions that improve efficiency and comply with FDA and global standards.
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