US Track & Trace Requirements

Recommendation

5/6 June 2024

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The US Food and Drug Administration (FDA) has issued a questions and answers document to assist industry and State and local governments in understanding the effects of the Uniform National Policy on drug product tracing. The Drug Supply Chain Security Act (DSCSA), establishes a Federal system for tracing prescription drugs through the distribution supply chain and requires trading partners to pass, receive, and maintain certain product and distribution information (see also US Pharmaceutical Distribution Supply Chain: Revised Draft Guidance on Verification Systems).

Drug Supply Chain Security Act (DSCSA)

The DSCSA outlines critical steps to build an electronic, interoperable Track & Trace system for certain prescription drugs when distributed in the US. In addition, definitions, requirements for supply chain actors (i.e., manufacturers, wholesale distributors, dispensers, and repackagers), standards for and licensing of wholesale drug distributors and third-party logistics providers are provided. Manufacturers are required to test electronic connections with trading partners as the November 2023 deadline for having these systems in place approaches.

Moreover, supply chain actors are required to have verification systems in place to verify suspect product. This includes determining whether the product identifier (PI) affixed to, or imprinted upon, the package corresponds to the information assigned by the manufacturer or repackager. The PI includes the standardized numerical identifier (SNI), lot number and expiration date of the product. The SNI includes the products National Drug Code (NDC) and the serial number. The FDA previously provided a Q&A document on Product Identifiers Under the DSCSA. The PI data is specifically required to be in a 2-dimensional data matrix code for packages and in a linear or 2-dimensional data matrix code for homogenous cases (i.e., a sealed case containing only product that has a single NDC number belonging to a single lot).

The Uniform National Policy states that no State (or political subdivision of a State) may establish or continue in effect any requirements for tracking & tracing prescription drugs throughout the distribution supply chain which are inconsistent with, more stringent than, or in addition to, any requirements applicable under the FD&C Act (as amended by the DSCSA). The agency has issued this guidance to help industry and States understand the law as it is currently in effect. More information is provided in FDA´s Guidance document Drug Product Tracing: The Effect of Section 585 of the FD&C Act.