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Senate Considers Drug Quality and Security Act

Posted in Adverse Events, Compliance, Drug Security, Mislabeling, Supply Chain

The U.S. Senate is reviewing a new bill, the Drug Quality and Security Act, which would amend the Food, Drug, and Cosmetic Act.  The bill was originally introduced in the House of Representatives (as H.R. 3204) and would alter the regulation of compounded drugs. Among other things, if enacted, the legislation will enhance regulation of such drugs.  It will also increase government oversight with respect to those compounded drugs that are especially prone to adverse events.