SNI Working Group
SNI: Standardized Numerical Identification for Prescription Drugs
The Drug Quality and Security Act (DQSA) was signed into law by President Obama on November 27, 2013. Title II of DQSA, the Drug Supply Chain Security Act (DQSCA), outlines the steps to build an electronic system to identify and trace prescription drugs. This includes both prescription pharmaceuticals and biologicals (such as blood and parenteral drugs) distributed in the United States. These are collectively called drugs here. The DQSCA goals are to:
The FDA is developing a schedule for implementing the law’s requirements. Among key provisions implemented over the next 10 years are requirements for:
As the first of several guidances and regulations that the FDA plans to issue and implement, the “Standards for Securing the Drug Supply Chain – Standardized Numerical Identification (SNI) for Prescription Drug Packages” document indicates standards that must be developed for identification, validation, authentication, and tracking and tracing of prescription drugs. In this document, the FDA recommends specifically that the SNI for most prescription pharmaceutical packages should be a serialized National Drug Code (sNDC) corresponding to the specific drug product NDC combined with a unique serial number, generated by the manufacturer or repackager for each individual unit of sale package and applied to each new package in both human-readable and machine-readable forms.