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Wholesale Distributor Requirement for DSCSA 2017 May Be Patch Work

By October 28, 2015March 2nd, 2021Aggregation, DSCSA, Global Markets, Serialization

For the DSCSA 2015 implementation, the wholesale distributors (WD) rallied behind ASN as the agreed upon electronic product trace method. For the DSCSA 2017 implementation, manufacturers are anxious to know what will be required from the WDs, especially given the fact that their requirements are more stringent than those of the FDA. Manufacturers heard from Cardinal in June and AmerisourceBergen in July, both in the form of a survey. These surveys gauged manufacturers’ readiness on serialization, aggregation, and EPCIS capabilities. It was highly anticipated that McKesson would also send communications to the manufacturers by the end of summer. It is fall now, and the communication never came.

McKesson presented at the HDMA Traceability Seminar in Washington DC on October 13, 2015 and suggested that serialized ASN and EPCIS are in the company’s interest moving forward into the era of serialization. This implies that aggregation will also be required by McKesson. Aggregation enables serialized ASN and EPCIS. Without aggregation, the shipments are lot controlled and serial numbers are not captured or exchanged at shipping.

McKesson’s presentation invited questions from other WDs who believe that WDs should agree on a set of harmonized  industry requirements instead of issuing different individual requirements. The truth is that some wholesalers are ready for aggregation, serialized ASN, and EPCIS; but others are not. It takes significant time and capital investment for manufacturers to package with aggregation and to ship aggregated shipments. That similar investment is required of WDs in order to receive, put away, and manage aggregated drug products. The FDA does not require aggregation by 2017. But will the WDs require manufacturers to do so out of business reasons?

I am a strong supporter of WDs working together to harmonize their requirements. Serialization is no small feat, and aggregation is even more complex. Before DSCSA, the United States was in a patch work of state level pedigree laws that are very different from one state to the other. DSCSA resolved the chaos by unifying these requirements under one federal regulation. Having a patch work of WD requirements today would take the industry one step forward and two steps back. The most efficient model for WDs, manufacturers, repackagers, and dispensers to implement DSCSA effectively is to leverage on standards. Doing so promotes easier data exchange, better scalability, and less errors. The WDs would benefit from taking this approach as well as the manufacturers. Uniformity on standards creates a win win for all parties in the pharmaceutical supply chain.