Federal Court Enters Consent Decree Against Compounder

On Feb. 6, 2019, the US District Court for the Western District of Pennsylvania entered a consent decree of permanent injunction between the United States and Ranier’s Rx Laboratory Inc., doing business as Ranier’s Compounding Laboratory, of Jeanette, Pennsylvania, and pharmacist Francis H. Ranier, who owns the compounding facility. The consent decree prohibits the company and its owner from manufacturing, holding, or distributing human or animal sterile drugs until the company complies with the Federal Food, Drug, and Cosmetic Act (FD&C) and FDA regulations.

The consent decree states that the company manufactured and distributed products purportedly to be sterile that were made under insanitary conditions. The company and its owner may not resume sterile compounding until they complete corrective actions and then receive authorization from FDA.

“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 press release. “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.”

Source: FDA