2D Barcode Labels /
Track and Trace Labels
In March 2010, the Food and Drug Administration (FDA) established a “Final Guidance” for securing the drug supply chain. Under this guidance, Standardized Numerical Identifiers (SNIs) are required for identification, validation, authentication, and tracking and tracing of prescription drug packaging.
This SNI is applied at the point of manufacturing and repackaging at the package or pallet level. The SNI should be a serialized National Drug Code (sNDC). The sNDC is composed of the National Drug Code (NDC) that corresponds to the specific drug and its packaging, combined with a unique serial number, generated by the manufacturer or repackager for each individual package. Serial numbers should be numeric or alphanumeric and should have no more than 20 characters. By combining the SNI with the NDC, the sNDC should be strong enough to support billions of units of marketed products without duplication. SNIs can also be linked to databases containing specific drug information such as expiration date, lot or batch number, distribution and transaction history.
The FDA has not specified how the SNI needs to be applied to each package, while both human-readable and machine-readable formats are preferred. Machine-readable format includes 2-dimensional (2D) barcodes and radio-frequency identification (RFID). Both track and trace machine-readable options have advantages and disadvantages.
Considering 2D Barcodes vs. RFID?
A 2D barcode or data matrix code contains more information than a conventional 1D barcode. 2D barcodes consist of black and white square modules arranged in a square or rectangular pattern. These barcodes contain multiple levels of information such as lot numbers, date of manufacture, expiration date, manufacturer location and distribution channel, component details, and unique serial numbers. 2D Barcodes are easily added to cartons and labels that already exist since the amount of space needed is relatively small.
RFID is a semiconductor in a label or tag that stores information. Data is read or written to the tag when it is exposed to radio waves of the correct frequency. Some types of RFID chips include the following:
Passive – Small electrical current induced in the antenna by the incoming radio frequency signal provides just enough power for the chip’s circuit to power and transmit a response.
Active – Larger, more expensive tags since they are battery operated, but more robust in "Radio Frequency challenged" environments such as longer distance, humidity, and reflective targets.
Semi-Passive – Similar to Active chips, but the battery powers only the microchip and not the broadcasting of the signal. The response is powered by means of backscattering the RF energy from the reader similar to the Passive chip.
Extended Capability – Similar to Active chips, but more complex. Other key attributes include to store large amounts of data, to integrate with sensors, and to communicate with external devices.
RFID is used around the world, as are 2D barcodes. There is no doubt that RFID is a better option than 2D barcodes for some applications. While both 2D barcodes and RFID have initial start-up costs for software and scanning equipment, the major disadvantage of using RFID is the cost of the tag. With 2D barcodes, recurring costs drop since it is incorporated into the printing of the label or carton. RFID cannot replace the barcode, rather the two are meant to work in unison with each other. Barcode technology has greatly advanced in recent years and will continue to play a significant role in the tracking, tracing and authentication of a drug or product.