Drug, public interest groups split on compounding bill

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It would clarify oversight of the compounding facilities, putting the Food and Drug Administration (FDA) in charge of regulating larger compounders and leaving smaller establishments to state boards of pharmacy.

Not all organizations are on board, however.

The consumer interest group Public Citizen on Friday warned that the measure could allow compounding plants to label themselves “outsourcing facilities” and escape any FDA regulation at all.

“This means even drug manufacturers that currently make FDA-approved drugs would, under this measure, have the ability to make and sell drugs to meet shortages and ‘clinical needs’ without seeking premarket approval,” Michael Carome, the director of the group’s health research group, said in a statement.

“Such approval is a critically important requirement under existing law that has helped to ensure the safety and quality of drugs for more than half a century.”