Track-and-Trace Provider Kit Check Selected for FDA Pilot Program

By Emily Forster -

June 27, 2019

Kit Check, a provider of automated medication management solutions for hospitals, has announced it has been accepted into a pilot program by the US Food and Drug Administration Act for evaluating package-level tracing and verification technology in implementation of the Drug Supply Chain Security Act (DSCSA).

The DSCSA outlines steps to build an electronic, interoperable system to identify and trace prescription drugs as they are distributed in the US. It is designed to create a system that will facilitate the exchange of information at the individual-package level about where a drug has been in the supply chain.

The focused pilot will evaluate package-level tracing and verification technologies and explore radio-frequency identification (RFID) as an alternative data carrier to the 2D barcode, according to Kit Check. The program includes efforts from Hackensack University Medical Center, Coral Gables Hospital, Nephron Pharmaceuticals, and Sandoz, a Novartis division.

The goal of the pilot is to demonstrate how RFID data carriers for electronic data exchanges can provide interoperability and tracking improvements. With RFID, all parties involved could exchange product tracing information across the pharmaceutical distribution supply chain while identifying, managing, and preventing the distribution of suspect and illegitimate products.

The pilot will use existing 2D barcode monitoring technology and RFID so both methods can be evaluated and analyzed. The labels and markers will be included on a range of injectable drugs in vials and pre-filled syringes that meet the definitions laid out by the FDA, following their development from manufacturing through the hospital.

The pilot program is scheduled to last six months, according to Kit Check. Upon its conclusion, the FDA will make the final reports public alongside other DSCSA 2023 participants’ findings.

Source: Kit Check