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.
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.
The Department of Commerce is soliciting public comments to inform this investigation. Stakeholders are encouraged to provide input on various factors, including:
The current and projected demand for pharmaceuticals and their ingredients in the U.S.
The capacity of domestic production to meet this demand.
The role and risks associated with foreign supply chains.
The impact of foreign government subsidies and trade practices on U.S. industry competitiveness.
The feasibility of expanding domestic manufacturing to reduce import reliance.
Comments must be submitted by May 7, 2025, through the Federal Rulemaking Portal at www.regulations.gov, referencing Docket ID BIS-2025-0022. Submissions containing business confidential information should be clearly marked and accompanied by a non-confidential version.
For further details, please refer to the official notice in the Federal Register: Notice of Request for Public Comments on Section 232 National Security Investigation of Imports of Pharmaceuticals and Pharmaceutical Ingredients.
There are plenty of questions and speculation about what this means for specific supply chain participants. Contact Lanton Strategies to learn about how we can help you respond to these comments as well as help you speak with either Congress or the Administration to get your voice heard.
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.”
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.”
The rule can be found here. The comment period ends June 6, 2022.
Lanton Law has personal experience in the wholesale distribution industry.
Lanton Law is a national healthcare and life science boutique law and government affairs firm that closely monitors legislative, regulatory and legal developments for our clients. Our healthcare practice can help distribution stakeholders understand what’s at issue so that we can help our valued clients reach their goals. Contact us to learn about how either our legal or lobbying services can help you attain your goals.
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