The Superfoods Guide

The US Food and Drug Administration is developing its control over externally manufactured drugs in a bid to reduce the number of substandard medicines which enter the American market. Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting or PREDICT is a way to control the drugs which enter at the border. 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. The medicines will not be allowed into the US if FDA compliance has not been reached.

The products that go through the scanner will also be ranked. Those medicines which receive a low ranking will be subject to more intensive investigation before they are released onto the market. Through this the FDA wants to reduce the risk posed to US citizens by substandard foreign drugs. 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. And FDA compliance laws must also be adhered to if a foreign manufacturer wants to export their drugs to the US. 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 out of that 40%, nearly 80% of all active pharmaceutical ingredients come from foreign facilities.

This is a huge number of manufacturers and individual 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. The 2008 Heparin case which resulted in hundreds of deaths around the world is just one of them. 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