Federal Agencies Release Draft Guidance for Good Importer Practices

January 15, 2009
Pharmaceutical Technology Editors
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A draft guidance for industry titled "Good Importer Practices" has been released to provide importers guidance on the steps they can take to help ensure imported products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Rockville, MD (Jan. 12)-A draft guidance for industry titled “Good Importer Practices” was released to advise importers about the steps they can take to ensure that imported products comply with the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The draft guidance recommends that importers identify and minimize risks associated with imported products according to four guiding principles:

  • Establishing a product-safety management program

  • Knowing the product and applicable US requirements

  • Verifying product and company compliance with US requirements throughout the supply chain and product life cycle

  • Taking corrective and preventive action when the imported product is not in compliance with US requirements.

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 The draft guidance can be viewed here.