U.S. Reps. Rosa DeLauro (D-Conn) and Nita Lowery (D-N.Y.) have introduced a bill (H.R. 6638) that would increase government oversight of compounded drugs, like those purportedly implicated in a fungal meningitis outbreak that has caused 36 deaths and 541 illnesses nationwide. The proposed legislation would amend the Food, Drug, and Cosmetic Act to require notification to patients that a compounded drug has been prescribed, product labeling as a “non-FDA approved compounded drug product,” registration for drug compounders, training, the establishment of advisory committees, and reporting obligations.
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House Democrats introduce legislation to increase oversight of drug compounders
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