Public comments submitted to the US Food and Drug Administration’s (FDA) draft guidance on how and when to inform the agency of certain drug and biologic product manufacturing shortages mainly came from manufacturers wanted to know more about the notification process and what constitutes a discontinuation in the eyes of the agency.
FDA’s draft guidance instructs manufacturers to notify the agency at least 6 months in advance of when they have permanently discontinued the manufacturing of certain finished products or active pharmaceutical ingredients (APIs), or when an interruption in the manufacturing of certain finished products or APIs “likely to lead to a meaningful disruption in supply” in the United States.
The draft guidance also recommends manufacturers provide additional information in the notifications to the agency to give FDA the information it needs to help prevent or lessen shortages, such as the names of the finished products, alternative standards for identification and labeling, application holder name or manufacturer and drug master file number…
