DSCSA Serialization Requirements

Requirements for Serialized Numerical Identifiers (SNI) and Unique Product Identifiers (UPI) The DSCSA requires that manufacturers apply a “product identifier” on prescription drug products. A product identifier is defined as a “standardized graphic” including both human and machine readable data that contains the standardized numerical identifier, lot number, and expiration date of the product. Trading partners are also required to exchange product tracing information when transacting specific prescription drugs. 

  

 

Implementing serialization of single or LUM items in compliance with the phases of the DSCSA regulation is complex, costly, and labor-intensive.  Considerations include State and Federal licensing and regulatory compliance, production process investments, label and packaging design, inventory handling time, and unique customer requirements. 

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