February 3, 2023

PHE to end—and with it—temporary compounding GFIs

On Monday, Biden Administration announced it will end the Covid-19 national and public health emergencies on May 11. That means temporary guidance for industry that allowed 503As and 503Bs to prepare 13 COVID drugs for hospitals during the PHE will expire as well.

Responses to a 2021 APC survey indicated that at least 80 503As had sourced COVID shortage drugs to hospitals under that temporary guidance. Last September in an interview at APC’s Compounders on Capitol Hill event, FDA Director of the Office of Compounding Quality and Compliance Gail Bormel said she was not aware of any adverse events reported as a result of 503As compounding shortage drugs under the guidance.

“We’d like to see that guidance broadened to include not only all shortage drugs, but also urgent use drugs needed by hospitals and clinics, within tight regulatory guidelines,” said APC’s Scott Brunner. “HR3662 in the last Congress would have done that. We’re working now on a possible legislative proposal for this new Congress that would implement some provisions of that previous legislation, as well as eliminate the MOU in law (and replace it with mandatory reporting) and create a federally mandated adverse events reporting framework for 503A compounding pharmacies.”