If the guidance is approved, drug manufacturers would be legally required to immediately notify the FDA of permanently discontinued products and interruptions “likely to lead to a meaningful disruption in supply,” according to the draft published April 6 in the Federal Register.
The draft guidance also asks for notifications on permanently discontinued manufacturing of active pharmaceutical ingredients and possible supply disruptions of APIs.
At a Senate committee hearing in March, pharmaceutical supply experts testified about decadeslong issues with drug supply chains, including the lack of transparency from drug manufacturers and how it leads to a “never-ending game of drug shortage Whac-A-Mole,” one expert said.
The agency is asking for comments on the draft until June 5.
