FDA’s Recent Workshop
On Feb 15-16, FDA held a public workshop, “Determination of System Attributes for the Tracking and Tracing of Prescription Drugs,” which was attended by manufacturers, distributors, pharmacy representatives, government groups, and suppliers of software and technology.
The workshop was intended to provide a forum for discussing potential approaches toward a track-and-trace system. Supply-chain partners discussed potential system attributes and standards that may be needed to facilitate the identification, authentication, and tracking and tracing of prescription drug packages.
“There were good discussions among the participants, and we received a lot of good input at the workshop,” says Connie Jung, senior policy advisor, Pharmacy Affairs, FDA, & Commander in U.S. Public Health Service.
A summary of the discussions will be posted to FDA’s web site by the end of March.
“Overall, I think the participants felt happy to have the opportunity to provide their perspective, while also learning from other supply chain partners there,” says Jung. “We would be glad to hear other concerns on this issue,” she adds.
FDA welcomed comments to the docket at www.regulations.gov. The docket number is FDA-2010-N-0633.
Visit the Federal Registry notice here: http://www.fda.gov/downloads/Drugs/NewsEvents/UCM239407.pdf.