The Superfoods Guide

The border control policy of the US Food and Drug Administration is being developed in an attempt to cut the number of poor standard medicines which enter the country from outside. The new initiative which is called PREDICT – Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting – will be a border-based scheme which assesses drugs at the point of import. Barcodes on cases of medicines will be scanned at the US borders and linked to a central database. If the manufacturer does not have the correct licenses to sell their products in the US then the central database will be able to alert the border deputies of this fact. If the products do not meet FDA compliance they will not be allowed passed the borders.

The scanning process will also work on a ranking factor. If a low ranking score is given then a product will not be released onto the market until it has been through thorough inspection. The FDA hopes that this will reduce the number of substandard medicines which patients might take. The factors that the risk is measured by include the nature of the product, the reputation of the producer and market variables.

If you want to make and sell drugs in the US, you must meet FDA compliance. For producers wanting to sell their products in America, they too must meet FDA compliance laws. This means that the FDA is monitoring about 130,000 foreign importers every year and around 300,000 foreign facilities. Foreign imports make up about 40% of all the medicines that the American people take. And 80% of all the active pharmaceutical ingredients in these drugs come from foreign facilities.

This is a massive number of importers and products that the FDA has to monitor. There have been cases over recent years when contaminated medicines have found their way onto the US drug market and patients have become ill and even died. For example, a contaminated batch of Heparin caused hundreds of deaths around the world in 2008. PREDICT has been tested in Los Angeles and by the end of the Spring it is hoped that it will be in place around the country.

Tags: FDA auditing, FDA compliance, GMP auditing, pharmaceutical consultants, QP training