On January 30, Fresenius Kabi USA Vice President of Regulatory Affairs Molly Ventrelli testified before Congress on compounding.
The House Energy & Commerce Committee held a hearing on “Examining Implementation of the Compounding Quality Act.” Fresenius Kabi is a global health care company specializing in lifesaving medicines and technologies for infusion, transfusion and clinical nutrition.
The company operates 18 compounding centers around the world, and is in the process of launching its first U.S.-based, 503B compounding center in suburban Boston.
Drug compounding plays an important role in the delivery of health care by allowing a pharmacist, via a patient-specific prescription, to tailor a therapy for an individual’s unique needs. But it is critical to ensure the safety of patients receiving compounded medications.
Fresenius Kabi “commends the FDA’s implementation of the Drug Quality and Security Act” and “believes patient safety requires strict FDA oversight on outsourcing facility compounding by pharmacies that do not comply with FDA regulations,” Ventrelli told the subcommittee.
Ventrelli discussed quality, noting the FDA’s establishment and enforcement of two regulatory structures for the oversight of drug compounding—503A and 503B.
“In the interest of public health, the safety and manufacturing standards of compounders should be held to rigorous standards to ensure patient safety,” she said.
“It is our strong recommendation that the committee support FDA’s rigorous oversight of pharmaceutical compounding.”
By Rachel Schwartz, AAM Director of Communications