Hamburg supports legislation on FDA authority over compounding

FDA Commissioner Margaret Hamburg asked Congress to pass legislation that would give the agency authority to oversee compounding pharmacy practices. During a Wednesday hearing of the U.S. House of Representatives Energy and Commerce Committee's subcommittee on oversight and investigations, Hamburg said a lack of statutory authority hampers FDA's ability to "take action against compounding that exceeds the bounds of traditional pharmacy compounding."

Hamburg recommended that legislation recognize compounding as either traditional, which would remain subject to state regulation, or non-traditional, which would be subject to the same FDA inspection authority as drug manufacturers. Hamburg said non-traditional compounding would include compounding that poses a higher risk for a range of reasons, including the type or amount of drug being compounded or whether the pharmacy compounds the product before receipt of a prescription for a particular patient. ...