A Step Further in Track & Trace
No wonder the U.S. Food and Drug Administration (FDA) is concerned about counterfeiting and mishandling of prescription drugs.
As pharmaceutical thefts now represent 5% of all cargo thefts by volume, the concern for the consumer safety has become increasingly visible. Most recently, the FDA revealed a guidance defining the identification standard of prescription drug.
Optel Vision's efforts to provide a flexible serialization solution paid off : "Our software and platform does not require a single line of code change. Our solution is 100% compatible and compliant with the FDA's detailed guidance" declared Jean-Pierre Allard, product line manager.
The key items that the FDA guidance clarifies are:
An SNI (Standardized Numerical Identifiers) uniquely identifies the product at the package level.
The SNI takes the form of a serialized National Drug Code (sNDC) which is the item NDC and a Serial Number.
The Serial Number has a variable length up to 20 characters and can have letters and numbers.
The sNDC may be presented within a serialized GTIN (SGTIN) in a GS1 structure, which consists of converting the NDC to a GTIN and using the same Serial Number. The SGTIN can then be encoded in 1D or 2D barcodes or also in RFID inlays.
The guidance is the first of many guidances and regulations that the FDA will issue in order to secure the drug supply chain. The next expected documents should address the authentication and the tracking and tracing of prescription drugs.
As we move forward we must remember that we not only do this to eliminate counterfeit drugs onto the market but to provide the best possible safety solution for the manufacturer as well as the consumer.
Optel Vision Serialization Team