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PDSA FAQs on Preemptive Effect of the DSCSA

Source: PDSA

National uniformity is established through the DSCSA by preempting certain state requirements related to product tracing, licensure of wholesale distributors, and licensure of 3PLs. The DSCSA requires a common understanding and approach from all stakeholders, including FDA, state regulators, and the regulated community. The questions and answers in this document are intended to promote such a common understanding among stakeholders by clarifying several issues that will help to facilitate a national uniform approach.

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Keywords: Preemption, Product Tracing, Licensure, VAWD

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The Pharmaceutical Distribution Security Alliance (PDSA) is a coalition of more than 25 stakeholders from throughout the pharmaceutical distribution supply chain committed to safeguarding patients by ensuring the chain remains as secure as possible.