ePT--the Electronic Newsletter of Pharmaceutical Technology
A draft guidance for industry titled "Good Importer Practices" has been released to provide importers guidance on the steps they can take to help ensure imported products comply with the relevant statues and regulations of the United States throughout a product's lifecycle.
Rockville, MD (Jan. 12)-A draft guidance for industry titled “Good Importer Practices” was released to advise importers about the steps they can take to ensure that imported products comply with the relevant statutes and regulations of the United States throughout a product’s life cycle. The document is a collaborative effort on the part of the US Departments of Health and Human Services, Agriculture, Commerce, Homeland Security, and Transportation as well as the US Consumer Product Safety Commission, the US Environmental Protection Agency, and the Office of the US Trade Representative.
The draft guidance recommends that importers identify and minimize risks associated with imported products according to four guiding principles:
The document is part of a broader strategic framework initiated by a multi-agency working group titled “Action Plan for Import Safety: A Roadmap for Continual Improvement.” The draft guidance can be viewed here.
Pharmaceutical Tariffs Are Imminent: How Industry is Bracing for Impact
April 16th 2025On April 14, 2025, the Trump Administration launched a national security-driven investigation into pharmaceuticals, a move that will likely result in tariffs being placed on pharmaceutical drugs, ingredients, and other components that are imported from outside of the United States.