FDA Guidance for enhanced Drug Distribution Security at the Package level under the Drug Supply Chain Security Act
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The FDA announced for availability a guidance for immediate implementation entitled "Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act."
This guidance is intended to assist supply chain stakeholders, particularly trading partners, with requirements for enhanced drug distribution security at the package level under section 582 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360eee-1), as added by the DSCSA (Title II of Public Law 113-54).
Summary:
The DSCSA was signed into law on November 27, 2013. The DSCSA outlines critical steps to achieve interoperable, electronic tracing of product at the package level by November 27, 2023.
These requirements will enhance the identification and tracing of certain prescription drugs as they are distributed within the United States. Section 202 of the DSCSA added section 582 to the FD&C Act, which established product tracing, product identifier, authorized trading partner, and verification requirements for manufacturers, repackagers, wholesale distributors, and dispensers to facilitate the tracing of products through the pharmaceutical distribution supply chain.
This final guidance addresses comments on the June 2021 draft guidance of the same name by clarifying the enhanced security requirements and describing recommendations for operational processes related to aggregation, reconciliation, and responding to verification requests. Broadly, the guidance covers enhanced drug distribution security (e.g., system attributes, aggregation and inference), system structure (e.g., data architecture, system security), enhanced product tracing, and enhanced product verification.
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