![]() ![]() “ The SNI for most prescription drug packages should be a serialized National Drug Code (sNDC). The term ‘product identifier’ means a standardized graphic that includes, in both human-readable form and on a machine-readable data carrier that conforms to the standards developed by a widely recognized international standards development organization, the standardized numerical identifier, lot number, and expiration date of the product.” (Section 581)īack in March of 2010-3 ½ years before Congress passed the DSCSA-the FDA published final guidance called “ Guidance for Industry, Standards for Securing the Drug Supply Chain – Standardized Numerical Identification for Prescription Drug Packages”, which defined the term “standardized numerical identifier (SNI)” this way: The Drug Supply Chain Security Act (DSCSA) defines the term “Product identifier” this way: market must put “serial numbers”, or “serialize” their drug packages and homogeneous cases before November 27, 2017, but what exactly does that mean? ![]() I often write about the fact that drug manufacturers and repackagers that sell into the U.S. ![]()
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