Compounder prohibited from making, distributing drugs
The U.S. District Court for the Western District of Pennsylvania has entered a consent decree prohibiting Ranier’s Rx Laboratory Inc. from manufacturing or distributing compounded drugs until they comply with the Federal Food, Drug, and Cosmetic Act and Food and Drug Administration regulations, the FDA announced yesterday. A complaint filed with the consent decree alleges that the company’s purportedly sterile drug products were made under insanitary conditions. FDA last year alerted health care providers and patients not to use those products.
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