PDA Letter Article

News Brief: Dept. Commerce Seeks Comment on Pharma Import Risks

Walter Morris, PDA

An exterior photo of the Herbert Hoover building in Washington, D.C. where the headquarters of the U.S. Department of Commerce is locatedOn Wednesday, April 16, the Federal Register included a Notice of Request for Public Comments from the Department of Commerce’s Bureau of Industry and Security on Section 232, National Security Investigation of Imports of Pharmaceuticals and Pharmaceutical Ingredients.

The Secretary of Commerce initiated an investigation to determine the effects on the national security of imports of pharmaceuticals and pharmaceutical ingredients, including finished drug products, medical countermeasures, critical inputs such as active pharmaceutical ingredients, and key starting materials, and derivative products of those items. This investigation has been initiated under section 232 of the Trade Expansion Act of 1962, as amended. Interested parties are invited to submit written comments, data, analyses or other information pertinent to the investigation to the Department of Commerce’s (Department) Bureau of Industry and Security (BIS), Office of Strategic Industries and Economic Security.

DATES: Comments may be submitted at any time but must be received by May 7, 2025. ADDRESSES: Comments on this notice may be submitted to the Federal rulemaking portal at: www.regulations.gov. The regulations.gov ID for this notice is BIS– 2025–0022. Please refer to XRIN 0694– XC120 in all comments.

The full notice can be found here.