‘The Smallest Individual Saleable Unit’ In The DSCSA - RxTrace

Drawing from the GS1 Healthcare GTIN Allocation Rules document showing how to assign GTINs in multi-pack scenarios. Click image to enlarge.

The U.S. Drug Supply Chain Security Act (DSCSA) requires manufacturers and repackagers to place DSCSA-specific “product identifiers” on all drug packages and homogeneous cases by November 27, 2017 (2018 for repackagers).  These product identifiers must include a Standardized Numeric Identifier (SNI), which is composed of the drugs National Drug Code (NDC) and a unique serial number (for more on DSCSA “product identifiers”, see “The DSCSA Product Identifier On Drug Packages“, for more on the SNI, see “FDA Aligns with GS1 SGTIN For SNDC“, and for more on the NDC, see “Anatomy Of The National Drug Code“).
A common question is, what is the smallest level of packaging that must be serialized?.  The DSCSA text provides the answer.
This is an update to an essay I wrote back in 2013 about the same topic, but for the California pedigree law (see “InBrief: ‘The Smallest Package Or Immediate Container’ In California“), which was subsequently preempted by the DSCSA.  The California pedigree law would have required manufacturers to serialize the smallest package of drugs that will be bought by a dispenser.  The DSCSA is basically the same.  For some manufacturers targeting the U.S. market, that may require serialization at a lower unit of measure than they might have thought.  For products that manufacturers package into multi-packs and sell to wholesalers packaged only that way, you might assume that your “smallest individual saleable unit” is the multi-pack. Think again....
Read the full post at RxTrace.com