Imported Medicines And Control Through FDA Compliance In The USA
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. PREDICT or Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting will assess every medicine at the border as it is being imported. A central database will be linked to the borders so that barcodes on medicine packs can be scanned and identified. 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 products have a low ranking then they will be put through thorough investigation before they are approved for sale in the US. The FDA hopes that this will reduce the number of substandard medicines which patients might take. Market variables, the reputation of the manufacturer and the type of drug are some of the factors which will influence the ranking score.
At the moment, FDA compliance is a legality for medicine manufacturers in the US. And FDA compliance laws must also be adhered to if a foreign manufacturer wants to export their drugs to the US. At the moment, there are 130,000 foreign importers and 300,000 foreign facilities which the FDA has to monitor. Out of all the medicines that American people take, about 40% are from foreign producers. And 80% of all the active pharmaceutical ingredients in these drugs come from foreign facilities.
This is a huge number of manufacturers and individual products that the FDA has to monitor. There have been previous cases where contaminated medicines reached the US pharmaceutical market and caused illness and even death. One example is the 2008 case of contaminated Heparin which caused hundreds of deaths worldwide. A trial of PREDICT has been carried out in Los Angeles and the programme should be rolling out around the country by the end of Spring.
Tags: FDA compliance, GMP training, pharmaceutical consultants, QP training
