What is the Origin of Drug Serialization?

The practice of serialization arose primarily as a global response to the escalating threat of counterfeit pharmaceuticals entering the legitimate supply chain, driven by legislation like the US Drug Supply Chain Security Act. Its origin is rooted in the pharmaceutical industry's need for end-to-end product tracking and verification. This systematic approach is an evolution of earlier, less secure methods of batch-level tracking.

What is the Mechanism of Drug Serialization?

The mechanism involves applying a standardized, two-dimensional barcode, often a Data Matrix, to the smallest saleable unit of the drug. As the product moves through the supply chain—from manufacturer to dispenser—each change in ownership is recorded and verified against a central or distributed database using the unique serial number. This process allows for immediate verification of authenticity at the point of dispensing, ensuring that patients receive legitimate and potent hormonal medications necessary for their clinical outcomes.

Drug Serialization ∞ Area

Drug Serialization

Meaning

Drug serialization is a stringent regulatory requirement mandating that every single unit of a prescription medication, including hormonal therapies, be marked with a unique, verifiable identifier at the packaging level. This unique code typically includes the product code, a serial number, the lot number, and the expiration date, creating a distinct digital fingerprint for each package. This critical process establishes an unalterable link between the physical product and its digital history, serving as the foundation for secure supply chain management. It is a powerful defense against the proliferation of counterfeit or adulterated hormonal drugs that pose a significant public health risk.