The US Food and Drug Administration (FDA) published its proposed rule National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers on February 4, 2022. The proposed rule sets national standards for the licensing of prescription drug wholesale distributors (WDDs) and third-party logistics providers (3PLs) with the goal of strengthening the security of the US drug supply chain. When finalized and effective, these licensing regulations will pre-empt state and local licensing standards, requirements and regulations that are different from these federal requirements.
FDA Publishes Proposed Rule on National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers
By Brian Malkin and Harrison Farmer on April 13, 2022
Posted In Employee Benefits, Health and Welfare Plans
Tags: 3PLs, and Cosmetic Act, Docket No. FDA-2020-N-1663, DQSA, Drug, Drug Quality and Security Act, drug supply chain, Drug Supply Chain Security Act, DSCSA, FDA, Federal Food, National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers, prescription drug wholesale distributors, third-party logistics providers, US Food and Drug Administration, WDD
Brian MalkinBrian Malkin counsels pharmaceutical and biologic clients on Food and Drug Administration (FDA) regulatory matters and intellectual property (IP) law, with an emphasis on patent litigation. His practice at the intersection of FDA- regulated products and patent law makes him a valuable partner to drug manufacturers, biotechnology clients, medical device companies and cannabis companies as they develop new products and protect their innovations though life cycle management, bring their products to market and pursue transactional opportunities.Read Brian Malkin's full bio.
Harrison FarmerHarrison R. Farmer advises life sciences and healthcare clients on a wide range of matters that impact these industries. He counsels medical device, pharmaceutical, technology and biotech companies on US Food and Drug Administration (FDA) regulatory and compliance matters involving the full range of FDA-regulated products. He also counsels on healthcare transactional, regulatory and enforcement matters, particularly focusing on issues involving the Centers for Medicare & Medicaid Services (CMS), the Department of Justice (DOJ) and the US Department of Health and Human Services (HHS) Office of Inspector General (OIG).Read Harrison Farmer's full bio.
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