Nathan Brown Quoted by POLITICO on Drug Quality and Security Act
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POLITICO blog Prescription Pulse, for its article “Unsolicited Advice on Drug Labeling Rule, Compounding,” quoted Akin Gump health care and life sciences partner Nathan Brown on the genesis of the 2013 Drug Quality and Security Act.
Brown, an FDA policy advisor to the Senate HELP Committee at the time the law was drafted, said that the Act was created to draw a “bright line of demarcation between pharmacy practice and outsourcing,” noting that states would be responsible for overseeing pharmacists compounding drugs with an individual patient prescription, whereas the FDA would supervise outsourcers compounding drugs without specific prescriptions.