March 4, 2022

APC to FDA‘s Califf: Engage on compounding

APC this week sent a letter to newly confirmed FDA Commissioner Robert Califf, reminding him of the critical role compounding plays for millions of Americans. CEO Scott Brunner pointed out, for example, that Dr. Califf’s patients at Duke University Medical Center likely benefited from some of the half-million doses a year provided by Duke Compounding Facility.

Our hope is that Commissioner Califf will engage with us on compounding issues — cBHT access, adverse-event reporting, FDA’s MOU, and more in ways that previous commissioners have not always done.

To that end, Brunner reiterated APC’s desire to find common (or at least middle-) ground where APC can help FDA “achieve some of its patient safety-focused policy aims regarding compounding, while also elevating the practice of pharmacy compounding and its rightful place in the drug supply chain and American healthcare system.”

You can read the full letter (2-page PDF) here.