As the November 2017 serialization deadline inches closer, wholesale distributors are thinking about practicality. Cardinal and AmerisourceBergen issued industry letters to their manufacturing suppliers in late February, stressing the label test and master data exchange. McKesson followed suit shortly after, sending a supplier communication letter in mid-March. McKesson’s letter carries a similar message regarding the DSCSA serialization requirement, but with a bonus: a bundle of self-help materials for the manufacturers to digest and adopt. McKesson’s communication was sent to suppliers as a short email with six attachments:
- McKesson DSCSA supplier letter
- Conversion of NDC to GTIN14
- Supplier Serialization Piloting
- Sample GS1 EPCIS Events Single PO
- GS1 EPCIS Events Multiple PO
- HDA Bar Code Quick Start Guide
Comparing McKesson to Cardinal and AmerisourceBergen
If you work in the pharmaceutical industry, you’re well versed by now in the United States’ DSCSA requirements. (If not, please call my office and we’ll answer all your questions and provide materials and insight.) To cover the necessary ground, all three wholesale distributors iterated the DSCSA regulatory requirement. If you’re involved with DSCSA implementation, you understand that complying with DSCSA is like sorting through a giant spider web of different and highly complex regulatory items – packaging, labels, standards, data, and more. Trying to communicate in a two-page document all of those regulatory items and advice for their practical implementation is a difficult task. Considering the difficulty they faced, I say all three wholesale distributors did well. Especially McKesson, who gets A+ for providing self-help style attachments, which are welcomed by manufacturers.
Let’s look at all three letters and compare what was said in each.
 ABC informs the manufacturers that, “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.”
The “blanks” or unknowns were not mentioned in the letter. But that doesn’t mean they are not required. Some requirements were covered in previous communication letters; however, not in this round. To get more details on wholesale distributor requirements, please call LSPediA (248.973.2008) and we will be happy to help you.
In a sense, the three wholesale distributors are asking for two big things: 1) get your labels right 2) send the right serial data. These two are the key serialization requirements—and most problematic. If distributors can scan your labels and get your EPCIS data without issues, then they are happy. Easier said than done, right? Based on my own experience working with CMOs, manufacturers, and wholesale distributors, I sympathize with their concerns. More than half of the labels and data that came cross our desks have issues. These issues simply must be resolved before the products can go out of the door. If your downstream partners can’t read your labels or data, they can’t move the products forward – expect as returns and lost sales.
Get Serialization Expertise and Industry Insights, from LSPediA
Meeting DSCSA and wholesale distributor requirements is critical to every manufacturer’s business. Remember, the labeler has the ultimate responsibility—and liability—to the FDA and customers. If you’re concerned about meeting the November deadline—for whatever reason—I can help.
My company, LSPediA, offers a bundled serialization solution that can help companies like yours quickly implement and meet the FDA DSCSA mandates and wholesale distributor requirements. Many companies like yours have worked with us to get on schedule for compliance using two of our solutions:
- Serialization Toolkit: Serialization onboarding that leverages industry practice practices, reduces workloads, and eliminates unnecessary investments.
- RxChain Solution: A supply chain solution for managing serial data, serialized warehouse, aggregation, and data exchange with wholesale distributors.
Get our bundled solution and meet the serialization requirement in as few as eight weeks. If you’re interested in learning more, contact us and I will set up a time to call you for Q&A.
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.
We value long-term relationships and work with our clients’ internal teams to properly define roadmaps, create architectures, and implement systems that align to vital business goals. Our expertise, experience, and technical know-how help customers derive maximum value from their investments, both now and well into the future.
For additional information, contact: Julianne Jahn [email protected]