Case Against Compounding Facility, Owner Over Insanitary Conditions Resolved in Federal Court – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889
A complaint filed by the US Department of Justice on behalf of the FDA against a Pennsylvania compounding facility and its owner was settled today in the US District Court for the Western District of Pennsylvania. The court entered a consent decree of permanent injunction between the United States and Ranier’s Rx Laboratory Inc. of Jeanette, Pennsylvania, and owner-pharmacist Francis H. Ranier.
“We continue to see concerning activity when it comes to some compounded drugs, including problems related to the conditions under which compounded sterile medicines are made, which can raise significant risks to patients. This is an area of intense focus for the FDA. We’re committed to making sure that compounded drugs are made under appropriate production standards and, when necessary, taking enforcement actions against compounders who fail to produce sterile drugs in compliance with the law,” said FDA Commissioner Scott Gottlieb, MD, in a statement. “Despite our warning, Ranier’s and its owner placed patients at risk by compounding purportedly sterile drug products under insanitary conditions. The FDA will continue to pursue enforcement action against companies and owners who place American consumers at risk.”