FDA Warns Of 2 Hazardous Chemicals Used In Drugs

Law360, Washington (March 1, 2012, 6:38 PM EST) -- The U.S. Food and Drug Administration released a draft guidance Thursday discouraging the use of two phthalates in drugs and biological products, saying they could have negative effects on human endocrine systems and potentially cause reproductive or developmental problems.

The guidance represents the Center for Drug Evaluation and Research's thinking on the potential human health risks associated with exposure to dibutyl phthalate, or DBP, and di(2-ethylhexyl) phthalate, or DEHP, according to the FDA.

“There is evidence that exposure to DBP and DEHP from pharmaceuticals presents a...
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