Edge Pharma to Stop Producing and Distributing Compound Drugs

Edge Pharma, a compounding pharmacy based in Colchester, Vt., has entered into a consent decree in a federal court to cease manufacturing and distributing drugs until it takes steps to get back into compliance with FDA requirements.

In a May 20 complaint in the U.S. District Court for the District of Vermont, the Department of Justice (DOJ) accused the company of manufacturing and distributing adulterated and misbranded drugs and of introducing unapproved drugs into interstate commerce.

The complaint noted that FDA inspections between 2014 and 2021 had found a variety of problems, including recordkeeping violations, labeling inadequacies, improper airflow, structural disrepair and the presence of mold in cleanrooms.

DOJ said it will “continue to work closely with the FDA to ensure that drugs are compounded in compliance with the law.”