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RADIOACTIVE CONTAMINATION WARNING ABOUT DRUG AND BIOLOGIC MATERIALS

Executive Summary

RADIOACTIVE CONTAMINATION WARNING ABOUT DRUG AND BIOLOGIC MATERIALS imported from countries in proximity to the Chernobyl nuclear power plant was sent by FDA on May 16. FDA Center for Drugs and Biologics Office of Compliance Director Dan Michels advised that it is "prudent for drug producers in the U.S. to consider the origins of materials imported after April 1986, and assess the possibility of exposure to potential contamination." Michels stated: "We expect that the assessment will take into consideration such factors as environmental exposure, proximity to the reactor site, and potential routes of contamination, such as water retention by botanicals and components of animal origin where animal food supplies may have been a contributing factor." He said "if it appears that materials in your control are at risk in this matter, we expect you to take reasonable measures, within the context of current good manufacturing practice, to test and, where indicated, to remove contaminated articles from routes of distribution." Michels said the agency has no information at this time about contaminated drugs, biologics, or their components, that originated in exporting countries near Chernobyl. He noted that food samples collected by FDA "have thus far revealed some elevated levels of radioactivity, although well below any level of health concern."

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