Neither the Drug Supply Chain Security Act (DSCSA) in the United States, nor the Falsified Medicines Directive (FMD) in the European Union explicitly mandates the capture or use of aggregation data (see “Aggregation –> Chargeback Accuracy –> ROI” and “EU FMD: Aggregation Is Not Mandated, But It Will Be Necessary“). In this instance, “aggregation data” is data that documents the serialized packaging containment hierarchy of drug products—also known as “parent-child relationships”. It is well established that companies are not required by law to capture it, but for the smooth operation of pharma supply chains under a serialization, tracing and/or verification regulation, high quality aggregation data will be necessary. But there are warning signs that a significant percentage of drug manufacturers are not going to meet that bar by the deadlines. Continue reading Aggregation: The Achilles’ Heel of Pharma Supply Chain Operation Under A Serialization Regulation
I was on vacation last week and only arrived home Sunday evening so I didn’t have time to write an essay for Monday, but this is Tuesday! Near the end of last month there was a spike in the number of things that need to be covered in RxTrace. Two of them are important things from HDA and the Center For Supply Chain Studies. I’ve been waiting for both for months, and here they are. 
The lack of simple, standard, low cost product master data synchronization threatens to derail the industry’s general consensus-plan to use 
In a lengthy comment submission to the FDA’s recent publication of draft guidance on Standardization of Data & Documentation Practices for Product Tracing (see “
Dear Blockchain Vendors,
The second—and longer—draft guidance document the FDA published on the day of the third DSCSA public meeting is a “catch-all” (see also “