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FDA releases question and answer draft guidance on drug product tracing and licensing requirements.
FDA has issued guidance that answers questions in relation to the effects of section 585 (Uniform National Policy) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) added by Title II of the Drug Quality and Security Act (DQSA), also referred to as the Drug Supply Chain Security Act (DSCSA), which was enacted on Nov. 27, 2013. The intent of the guidance is to clarify the immediate effects of DQSA and section 585’s effect on state product tracing and standards and requirements for wholesale distributor and third-party logistics provider licensing.
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.”