TBA Law Blog

Posted by: Katharine Heriges on Oct 23, 2018
On Tuesday, a U.S. District Court judge issued a consent decree of permanent injunction against Tennessee over-the-counter drugmaker Keystone Laboratories barring the company from manufacturing or distributing drugs until it complies with the requirements in the decree, Regulatory Focus reports. The injunction comes after the Department of Justice, on behalf of the U.S. Food and Drug Administration, filed a complaint against the company and its owner and operator in September. According to the complaint, Keystone violated the Food, Drug and Cosmetic Act by distributing over-the-counter drug products that were not manufactured in accordance with current good manufacturing practices and in some cases did not have adequate labeling. The company has agreed to be bound by the consent decree.