Whether it was coincidence or a coordinated effort doesn’t really matter: The pharmaceutical industry was just happy to finally receive serialization requirements from the second- and third-largest wholesale distributors in the U.S. – AmerisourceBergen (ABC) on April 21 and Cardinal Health on April 22.
Both included two much-appreciated resources: a clarifying letter to suppliers and a serialization technical guide containing detailed requirements and timelines.
Last week I offered my take on Cardinal’s supplier letter and serialization requirements. Now, let’s dive into what ABC has communicated.
ABC’s Serialization Requirements – Plenty of Detail
Like Cardinal, ABC seems to have understood the industry’s need for specifics. The organization’s supplier letter and technical guide, called “AmerisourceBergen Corporation Serialization Labeling Guidelines and Requirements,” will calm executive nerves at many pharmaceutical supplier and manufacturing companies. Here are ABC’s specifications for manufacturers:
- Serialized Product Labeling: “AmerisourceBergen requests that its trading partners follow GS1 standards and the HDMA guidelines for labeling on both case- and unit-level products. We will not be able to accept any other labeling or barcode standards outside of the GS1 standards, but we will work with the manufacturers on identifying and correcting any labeling issues prior to November 2017.”
- Data Exchange: “AmerisourceBergen will continue to receive lot-level information via electronic ASN or, if you choose, via GS1 EPCIS format.” This requirement, which covers the lot-level data exchange, is consistent with other wholesaler distributors and – for the time being – keeps everyone on the same page using ASN for receiving logistics and DSCSA TI/TH/TS compliance.
- Returns Verification: “…AmerisourceBergen is investigating the concept of verifying all returns against an internal database. With this approach in mind, starting early 2018 we ask that you provide EPCIS electronic serialized transactions and a list of standardized product identifiers for the cases and units that you ship to our distribution centers so that we may populate our internal AmerisourceBergen serialized database.”
- Aggregation: “AmerisourceBergen requests that manufacturers aggregate in order to enable an efficient way for the supply chain to meet the 2019 saleable returns obligation.” Going further than Cardinal’s expectation that “manufacturers will aggregate individual units to the case level,” ABC is requesting that manufacturers aggregate “units to homogenous cases, units to non-homogenous cases, and cases to pallets.”
Cardinal and ABC’s communications do differ in one important way: While Cardinal’s technical guide describes the testing process, serialized data exchange, labeling, and EPCIS events, ABC’s guide is specific to serialization labeling. Aligning to GS1 standards, the ABC guide provides label samples which contain specification data elements for unit, case, pallet, and non-homogeneous case packaging.
ABC and Standardized Numerical Identification
More interestingly, the guide addresses the Standardized Numerical Identification (SNI) format laid out in the FDA’s SNI Guidance document issued in March 2010. ABC states, “according to GS1 and current best practices, this is NOT an accepted SNI”. The FDA SNI Guidance defines SNI as the National Drug Code (NDC) combined with a unique serial number up to 20 characters in length.
So what will ABC accept? Their technical guide explains that manufacturers need to convert the NDC number to Global Trade Item Number (GTIN) number. LSPediA recommends manufacturers use the following data construction for SNI.
Overall, the ABC communication was clear, specific, and thorough. But we now have three letters – from McKesson, Cardinal, and ABC. While there are similarities and a certain level of overall agreement across the three sets of specifications, manufacturers and suppliers will need to pay close attention to the differences in order to comply. Next week, I will compare all of the communications and describe how businesses can prepare to get on board with three sets of requirements.
LSPediA: DSCSA Compliance and Serialization You Can Trust
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LSPediA helps pharmaceutical manufacturers and distributors implement serialization and aggregation processes to meet global regulations, DSCSA requirements, and future track-and-trace mandates. Our services include URS, RFQ, gap analysis, serialization toolkits and solutions, DSCSA strategies, management consulting, and more.
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