The big three wholesale distributors have sent at least one DSCSA communication letter to the manufacturers per year for the last three years. Last week, AmerisourceBergen (ABC) issued the 2018 Supplier Letter titled “Preparing for Serialization – AmerisourceBergen’s Position on Processing Serialized Products”.
Consistent with the look and feel of previous communications, the letter clarifies ABC’s position on key FDA DSCSA requirements and calls the manufacturers to action for implementation. Looking back 3 years, the bones of these requirements have stayed the same, but the calls for action have evolved.
Notable at once is ABC’s position on processing grandfathered products.
“In order to continue to receive non-serialized products, AmerisourceBergen will treat any product that is not serialized after November 2019 as Grandfathered. We will reference the Transaction Statement (TS) as evidence that a manufacturer is complying with all provisions of the law, including the Grandfathering provision.”
The FDA’s Grandfathering Policy requires “manufacturers retain packaging date information in the ordinary course of business and as a part of batch recordkeeping, and they should provide the packaging date to subsequent trading partners if they request it.”
The application of requesting and providing packaging data for non-serialized products over millions of transactions is simply impractical for all parties involved. By utilizing the Transaction Statement, ABC resolves the issue without burdening any trading partners. The ball is now in manufacturers’ court for compliance adherence.
Other news stems from changes in the implementation timeframe.
“We are asking manufacturers to either 1) send serialized data upon shipment to AmerisourceBergen, or 2) leverage a Verification Router Service (VRS)…we would like to start collecting production data, via EPCIS 1.1 or EPCIS 1.2, no later than February 2019.”
The same was said in 2017 except the production EPCIS starts Mid-2018, and VRS was “Verification Query Service”.
In this new letter, ABC also shares their “thinking” with manufacturers on data exchange and technology alignment.
“…we expect all manufacturers or their solution providers, to be interoperable with the MediLedger network and aligned with the VRS Business Requirements developed by the HDA VRS taskforce…we are looking to use electronic solutions to gather this (master) data, such as HDA Origin or GS1 GDSN. It’s expected that for any new product launches, GTIN data will be provided using the above master data solutions or be provided on the HDA New Product form.”
The Requirement Evolution
If the above call-out from the letter is news to you, you are not alone. Unless you are someone like me who lives and breathes DSCSA, you will need an interpreter to understand this letter. In my research for this article, I retrieved the ABC’s 2016 letter and 2017 letter for comparisons. In 2016, ABC outlined four key DSCSA requirements in broad brushstrokes.
- Serialized product labeling
- Data exchange
- Returns verification
In the fall of 2017, GS1 US published the EPCIS 1.2 standard, a localized EPCIS 1.1 version specifically defined for the US DSCSA regulation. HDA completed the Returns Verification Pilot with several viable options. By November 2017, ABC issued the 2017 letter that announced the expectations for manufacturers to aggregate, send serial data via EPCIS, and stay up-to-date with the HDA VRS workgroup.
As of today, the HDA VRS workgroup is on target to wrap up the iteration one testing scoped for the Lookup Directory Sync and VRS Request/Response. Reflecting on the collaborative work from the workgroup, the 2018 letter shares ABC’s expectations of all manufacturers to be interoperable with ABC.
The DSCSA is a brand-new regulation. More guidance documents are yet to be published by the FDA. While the key regulatory requirements remain the same, the implementation and technologies will continue to evolve.
One can get lost in the jargon and lose focus of the end goal. To learn more about the DSCSA requirement and implementation, please send an email to [email protected] to request additional information.
- DSCSA Roadmap for Manufacturers
- DSCSA Manufacturer’s Requirement
- DSCSA Roadmap for Wholesale Distributors
- DSCSA Roadmap for Dispensers
Please specify your request by the number listed above. My office will send the documents to you in 24 hours.
Hassle Free DSCSA Implementation
- Data exchange in EPCIS 1.1 and 1.2
- VRS interoperable to ABC
In addition, RxChain® is the only solution with integrated hardware and software for warehouse data collection, enabling scans and transactions of serialized and non-serialized products.
- Warehouse Data Collection (Edge)
- Scanners, mobile devices and 2D label printers
We are on boarding new customers every day. Request a call or demo by emailing [email protected].
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.