Drug Supply Chain Security Act (DSCSA): Is Aggregation Necessary?

Aggregation is not an explicit or implied requirement of the DSCSA. There is no requirement forcing companies to know which serial numbers are inside a particular case. However, aggregation does have non-regulatory value to manufacturers. What makes aggregation controversial in the DSCSA is the term “verification.” What does “verification” mean, how is it going to be interpreted in future FDA guidance, and how is it going to be interpreted by customers? One question that remains unanswered is if a customer receives a case of a product along with serial numbers for each item in the case and later it is discovered that one of the listed serial numbers is not in the case, are they somehow liable because of the term “verification”?

The USDM Life Sciences Track & Trace Solutions and Services team will help you assess, plan and execute the changes and enhancements necessary to meet these regulations. Our team of experts will assess your products, the markets where they are sold and determine an implementation strategy for the changes that need to be made. USDM’s assessment methodology is extensive and includes the labels and packaging, the management of identification changes to each product, the changes to PLM, ERP, EPCIS and packaging systems, changes to printing, vision inspection and warehouse/inventory management systems and interfaces to foreign medical agency databases for pharmaceutical tracking. Also, USDM experts ensure that all changes and enhancements are implemented under the governing GMP regulations, under change control and validated prior to release for production.