FDA Rips Compounders Making Unapproved J&J Drug

Law360, New York (March 18, 2014, 3:54 PM EDT) -- The U.S. Food and Drug Administration on Tuesday released warning letters sharply criticizing two compounding pharmacies for allegedly producing a version of Johnson & Johnson gastrointestinal drug Motilium despite its lack of U.S. approval and for doing so in unsanitary conditions.

In letters to Louisiana-based Total Pharmacy Services Inc. and Florida-based Olympia Pharmacy, the FDA cited several areas of alleged noncompliance, some of which have become familiar during the agency’s lengthy crackdown on compounders.

Those included the manufacturing of drugs without individual prescriptions for specific patients...
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