Drugs

Drug Distribution Security Guidance

FDA has published a guidance, Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act, 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. The document says requirements for enhanced drug distribution security take effect on 11/27.

The guidance says it clarifies the enhanced drug distribution security requirements listed in Section 582 and outlines and makes recommendations for the system attributes necessary to enable secure tracing of products at the package level, including allowing for the use of verification, inference, and aggregation as necessary.

“FDA considers these recommendations to be important to assist in implementing the robust supply chain security envisioned under the Drug Supply Chain Security Act,” the guidance says.

The document contains an Introduction, Background, Enhanced Drug Distribution Security, System Structure, Enhanced Product Tracing, Gathering of Relevant Product Tracing Information, and Enhanced Verification.

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