Federal Court Enters Consent Decree Against Florida Compounder, Prohibiting Manufacture and Distribution of Drugs Due to Insanitary Conditions The U.S. District Court for the Middle District of Florida has entered a consent decree of permanent injunction that prohibits a Florida-based company from producing or distributing any drugs until the company complies with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and other requirements. According to the complaint, filed by the U.S. Department of Justice on behalf of the U.S. Food and Drug Administration (FDA), Premier Pharmacy Labs Inc. and the company's owner, Vern A. Allen, manufactured and distributed drugs made under insanitary conditions at Premier Pharmacy's facility, despite multiple warnings from the FDA. Premier stopped manufacturing drugs following an FDA inspection in June 2019. The consent decree requires Premier Pharmacy to not engage in any compounding operations or distribution until it completes corrective actions, to ensure the company and its facility are in compliance with the FD&C Act. Under the consent decree, Premier Pharmacy may not resume compounding operations until it establishes and implements, among other things, a comprehensive quality control system and receives authorization from the FDA. | 
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