The Federal Drug Administration (FDA) Appears to be Favoring RFID Over Barcodes

The Federal Drug Administration Amendment Act of 2007 (FDAAA) was developed when the Federal Drug Administration (FDA) was tasked with identifying specific standards. The portion of the FDAAA requires the FDA to create a standard and execution process to be able to uniquely identify pharmaceuticals at the unit-of-use level.

With only a little more than 2 years to accomplish this directive, the FDA began researching likely solutions and progressive technologies. A solution has not yet been selected and numerous technologies have not been discarded, it appears that the FDA is leaning toward Radio Frequency Identification (RFID) to achieve their goals, according preliminary Federal Register notices.

FDA Tracking Goals Prescription Drugs:

Identification

Validation

Tracing

Tracking

Authentication

For drug pedigree and trace and track functions, the FDA seemed to favor RFID over Barcodes. The two obstacles standing in the way of RFID as a solution – well it appear to be a little superficial.

1. Barcodes are widely used and accepted in the pharmaceutical industry – less education required to implement.
2. Barcode systems are perceived to be less expensive to implement.

I wouldn’t call that a win for barcodes just yet either. The ideal solution will be the one that can accomplish the complete set of goals through automated processes. Accuracy will be a huge factor in the decision as well. Many enterprises claim barcodes and RFID compliment one another and perhaps the solution is made up of more than one technology.

However, the attraction to RFID seems to be the EPC system. EPC codes have the capability to assign unique serial numbers at a does-level, package-level as well as several other levels.

Until the “verdict” is in and announced, we won’t know what solution the FDA will select to meet the FDAAA directive. We’ll keep you posted.

Could RFID automate your processes and eliminate human error? Dynamic Computer is a great source for RFID information and can help you determine if RFID is a viable option for your needs.

Visit the Dynamic Computer Corporation website or contact us 248-473-2200. We even have a Demo area to visually show you RFID in action.