US Good Importer Practices guidelines

19 January 2009

The US Departments of Health and Human Services, Agriculture, Commerce, Homeland Security, Transportation, as well as the Consumer Product  Safety Commission, the Environmental Protection Agency and the US  Trade Representative have issued draft guidance on Good Importer  Practices, to ensure that imported products are in compliance with the  relevant US laws and regulations.

Jeffrey Shuren, Associate Commissioner for policy and planning at the  Food and Drug Administration, said: "this draft guidance provides  importers with recommendations to assist them in preventing or  detecting potential problems at critical points along the product's  life cycle." Over the past couple of years, the FDA has had to cope  with contaminated medicines and food products, including counterfeit  supplies of the blood-thinner heparin, melamine-adulterated dairy  products and pet food and diethylene glycol in cough remedies and  toothpaste (Marketletters passim).

In a statement, the FDA listed the four guiding principles under which  the draft GIPs are organized: establishing a product safety management  program; knowing the product and applicable US requirements;  verification and company compliance with US rules throughout the supply  chain and product cycle; and taking corrective and preventative action  if the imported product fails to meet US standards.

This article is accessible to registered users, to continue reading please register for free.  A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Login to your account

Become a subscriber

 

£820

Or £77 per month

Subscribe Now
  • Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
  • Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
  • Daily roundup of key events in pharma and biotech.
  • Monthly in-depth briefings on Boardroom appointments and M&A news.
  • Choose from a cost-effective annual package or a flexible monthly subscription
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK







Today's issue

Company Spotlight