Practicality And Affordability Of Aggregating Pharmaceutical Products At The Unit Level On Packaging Lines

By Walter Berghahn, President, SmartRMeds For Life

Industry and regulatory organizations have been considering a serialization and traceability system for years. Most proposals involve serializing drug products at the smallest saleable unit. Among these, there are two opposing approaches regarding how drugs should be tracked:

• Unit serialization with required tracking at the unit level. This approach would enable supply chain visibility from the pharmacist back to the manufacturer for every discrete saleable drug product. The California e-Pedigree law, as well as other proposals federally advanced, would require this approach.
   
• Unit serialization with required tracking at the lot level. This approach would provide supply chain visibility between the manufacturers and distributors for every pharmaceutical product lot. These lots can vary in size and represent hundreds of thousands of different drug products created over long stretches of time. Pharmacists, however, would not be required, and in most cases would not be able to, authenticate an individual drug product.