FDA Serialization Guidelines
FDA Announcement on Drug Supply Chain Guidelines
Released on 3/26/10
The U.S. Food and Drug Administration (FDA) issued today final guidance and technical standards for securing the U.S. pharmaceutical supply chain. These long awaited standards for the numerical identification of prescription drug packages are part of an FDA-led effort to stem counterfeiting drugs. With today's announcement, the FDA is sending a clear message that serialization has an important and necessary role in pharmaceutical packaging.
According to the FDA, these guidelines should apply to packages considered "to be the smallest saleable unit placed into interstate commerce by the manufacturer or the repackager."
Further, the FDA recommends the use of a serialized National Drug Code (sNDC) "composed of the National Drug Code (NDC) (as set forth in 21 CFR Part 207) ... combined with a unique 8-digit numerical serial number generated by the manufacturer or repackager for each individual package."
Omega's Call to Action
Omega has long been tracking the FDA's thinking on serialization and e-Pedigree standards and is in a unique situation to support the industry's move towards serialization.
Learn more or watch a video of our serialization solution at: http://www.omegadesign.com/solutions/tnt.html
Omega is also a presenting sponsor of the Healthcare Packaging Conference & Workshops in Princeton, NJ on May 27. Our workshop, No Container Left Behind: How Early Tracking Ensures a Higher Standard of Quality Control, shall focus on the importance of early (pre-label) container identification and tracking, and present novel methods for using cost-effective technologies to secure a product's integrity.
FDA Guidelines are available here: http://www.fda.gov/RegulatoryInformation/Guidances/ucm125505.htm