Last October, I wrote about how wholesale distributors had yet to coordinate on a set of Drug Supply Chain Security Act (DSCSA) requirements, and how it was putting pharma manufacturers in a difficult position. On January 26, McKesson laid out its long-awaited requirements for drug manufacturers and suppliers. While there was no announcement on whether those rules will also be adopted by Cardinal and AmerisourceBergen (ABC), the expectation is that a business that meets the McKesson requirement will also meet Cardinal or ABC’s.
Here are the highlights from McKesson’s requirement announcement:
- Serialized DSCSA information will be exchanged using the GS1 EPCIS format.
- HDMS Advance Ship Notice (ASN) remains the same until Lot Level Traceability is sunset in 2023.
- Serialized item-level products need to be aggregated to upper level packaging(s).
- Cases need to be aggregated to a pallet/container and will require a SSCC barcode.
What this Means for Pharma Manufacturers
While we need to wait a bit longer for additional communications from other distributors, you can’t afford to wait on serialization implementation. It needs to become a top priority – if it isn’t already.
It also means that manufacturers need to plan for aggregation. In a nutshell, aggregation is serial-number based packaging hierarchy. If your business has serial numbers on at least some levels of packaging and shipping containers, you will have aggregation data – and understanding that data has now become crucial. (I explain the concept in more detail in this video.)
Aggregation could be the more difficult task for many organizations, because while serialization compliance has been on most people’s minds for a couple of years, aggregation needs have been a bit of an unknown. Now that distributors are providing some clarity, aggregation will become a priority.
LSPediA: Simplified Serialization and Aggregation Services
With the McKesson letter, the wait is over, and so is the uncertainty. It makes clear that the time to act on serialization and aggregation is now.
We at LSPediA are continually tuning our solutions to meet quickly shifting industry expectations. The LSPediA Serialization Toolkit is already helping companies like yours with efficient and flexible implementation options that ensure fast onboarding and complete control around all aspects of DSCSA compliance – including serialization, aggregation, and other regulatory and operational needs. To find out how we can give your company compliance piece of mind – and a competitive edge – contact us today. By understanding your needs, we can develop a customized strategy that’s just right for your business.