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Dioxin/PCB guidance

This article was originally published in The Tan Sheet

Executive Summary

FDA recommends manufacturers investigate the origin of animal-derived products used in drugs and biological products. The "Guidance for Industry: Possible Dioxin/PCB Contamination of Drugs and Biological Products" is being issued because of contamination that occurred from January through June in Belgium, France and The Netherlands. If materials are to be derived from poultry, swine or ruminants, manufacturers should obtain certification from suppliers that the animals were not raised in any of the three countries between January and June, according to the guidance. If products already have been produced using materials that cannot be certified, PCB or dioxin testing should be performed, and if their presence is detected, FDA should be contacted
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