FDA Seeks Input On The Future Format of the National Drug Code

Last week the FDA published a notice of a public hearing and request for comments regarding the impact of any future changes made to the length and format of the National Drug Code (NDC).  The current format of the NDC has been around since the early 1970s (see “Anatomy Of The National Drug Code”).  It has served the FDA, healthcare professionals and patients well since that time, but it is showing its age.  I call its affliction, “Identifier Failure” and I point out all of the symptoms for the aging NDC system in my essay “NDC Nearing Its End, Afflicted by ‘Identifier Failure’”.

It appears that the FDA recognizes these problems Continue reading FDA Seeks Input On The Future Format of the National Drug Code

Aggregation: The Achilles’ Heel of Pharma Supply Chain Operation Under A Serialization Regulation

View of a layer of drug cartons inside a case. Photo courtesy of Omega Design. Click image to enlarge.

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