To comply with U.S. federal serialization laws, packaging must include new serialization information and a scannable logistics data carrier. This includes the GS1 Global Trade Item Number (GTIN), serial number, packaging lot number, expiration date, and sometimes additional details. All inventory must meet these requirements by the deadline, and existing stock cannot be traded if non-compliant.
Serialized goods can be handled more efficiently by linking serialized contents with their containers (e.g., saleable units and shipping cases). This practice, already common in industries like electronics and machine parts, is expected to become a standard requirement in the life sciences supply chain by 2024. While not yet mandatory, businesses may adopt it sooner to streamline their operations.
GS1 is a key organization in setting standards for product serialization, using symbols like the GS1 DataMatrix 2D barcode. This symbol encodes essential data, such as the GTIN and U.S. National Drug Code (NDC) and is approved for use under the law. The GTIN can also include packaging characteristics, like quantity, and tracking codes like the Serial Shipping Container Code (SSCC) for containers that do not meet established quantities. Ensuring proper handling of partial cases is crucial, as incorrect encoding can cause confusion in the supply chain.
Manufacturers need new systems to manage and share serialization data with various supply chain partners, including contract packagers, third-party logistics providers, and health authorities. Some companies are implementing multiple-tier serialization solutions to reduce risks, using advanced systems at the packaging floor, warehouse, and enterprise levels.
