U.S. District Judge Lee Yeakel entered a consent decree of permanent injunction on March 10, 2015 between the United States and Specialty Compounding LLC, of Cedar Park, Texas, a compounding manufacturer who previously had drugs it manufactured recalled for potential contamination.
Specialty Compounding manufactured purportedly sterile injectable drug products that tested positive for bacterial contamination. The U.S. Department of Justice brought suit on behalf of the FDA in the Western District of Texas.
The consent decree prohibits Specialty Compounding and its owners from manufacturing, holding or distributing sterile drugs until they comply with the Federal Food, Drug, and Cosmetic Act and its regulations, in addition to other requirements.
The FDA issued a press release, noting: “Injectable drugs must be produced under sterile conditions,” said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research. “Specialty Compounding’s manufacturing practices and products put patients at risk. This consent decree reflects the FDA’s commitment to taking enforcement action against companies that fail to produce sterile drugs in compliance with the law.”