FDA is suggesting the voluntary use of a standardized numerical identifier (SNI) on prescription drug packages. You now have 90 days (from the Federal Register publication date) to comment on “Guidance for Industry: Standards for Securing the Drug Supply Chain – Standardized Numerical Identification for Prescription Drug Packages.”
The draft guidance recommends that the “SNI for most prescription drug packages should be a serialized National Drug Code (sNDC). The sNDC is composed of the National Drug Code (NDC) that reflects each corresponding manufacturer or repackager, combined with a unique 8-digit numerical serial number generated by the manufacturer or repackager for each individual package.” Expiration dates or lot codes are not suggested for inclusion in the code.
By using sNDCs, FDA believes that such identification can “facilitate authentication and tracking and tracing of prescription drugs.”
FDA also believes its suggested SNI is compatible with 2-D bar coding and RFID. Redundant human-readable SNI is encouraged.
FDA has started the year off with a mission focused on securing the supply chain. Earlier this week FDA announced its collaborative work with other government agencies in promoting import safety. Part of that effort entails its own draft guidance on Good Importer Practices. In all of these proposals, FDA speaks of securing the supply chain and utilizing track-and-trace technologies.
More guidances are coming, too. FDA announced a meeting on unique medical device identification, taking a lot-based approach. Expect more to come on systems for identification, authentication, and tracking and tracing. Case- and pallet-level standards are also a possibility.
You have been delayed and waiting for FDA. Not anymore, though!
What do you think? Did you expect the sNDC?