Lanton Law Blog

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Posts in drug distribution
Section 232 Targets Drug Imports: What It Means for Pharma and Healthcare

​On April 1, 2025, the U.S. Department of Commerce initiated a Section 232 national security investigation into the importation of pharmaceuticals and pharmaceutical ingredients. This inquiry aims to assess whether the reliance on foreign sources for essential medical products poses a threat to national security. The scope includes finished drug products, active pharmaceutical ingredients (APIs), key starting materials, and related derivatives.​

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FDA Proposes Rule Impacting Wholesale Drug Distributors & 3rd Party Logistics Providers

According to the Food and Drug Administration proposed rule, the (FDA) is “proposing national standards for the licensing of prescription drug wholesale distributors (“wholesale distributors” or “wholesale drug distributors”) and third-party logistics providers (“3PLs”), as directed under the Drug Supply Chain Security Act (DSCSA) (Title II of the Drug Quality and Security Act). Pursuant to the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the DSCSA, the proposed rule would establish standards for all State and Federal licenses issued.”

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