
FDA Releases Q&A on DQSA
FDA releases question and answer draft guidance on drug product tracing and licensing requirements.
FDA has
According to FDA, DSCSA “establishes a Federal system for tracing prescription drug products through the pharmaceutical distribution supply chain and requires trading partners to pass, receive, and maintain certain product and distribution information. The DSCSA also requires FDA to establish Federal standards for licensing of wholesale drug distributors and third-party logistics providers. Section 585 sets forth a uniform national policy preempting states from establishing or continuing in effect certain standards and requirements.”
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