FDA Lays Out Limits For Drug Impurities

Law360, New York (October 15, 2013, 7:19 PM EDT) -- The U.S. Food and Drug Administration described on Tuesday the acceptable levels of impurities in medications and the processes for detecting them, an approach the agency developed along with regulators in Europe and Japan.

In its 81-page guidance, the FDA spelled out five different classifications for various elements, from potentially dangerous substances such as lead, to relatively innocuous chemicals such as zinc.

Whether an element should be included as part of a formal risk assessment for contamination depends on its toxicity and, in some cases, whether...
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